Trial Outcomes & Findings for LEO 29102 Cream in the Treatment of Atopic Dermatitis (NCT NCT01037881)
NCT ID: NCT01037881
Last Updated: 2025-03-10
Results Overview
The EASI is a composite score based on the evaluation of four characteristic atopic dermatitis (AD) signs and symptoms; erythema, oedema/induration/papulation, excoriation and lichenification together with the area involved. For each body region, the investigator rated four clinical signs of AD using the following severity scale: 0 = none/absent 1. = mild 2. = moderate 3. = severe The EASI score ranges from 0-12, a higher score equals a worse outcome. Baseline was defined as Day 0. Mean values in table are least squares mean adjusted for the effect of (pooled) country.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
183 participants
Primary outcome timeframe
Baseline (Day 0) and end of treatment (Day 28)
Results posted on
2025-03-10
Participant Flow
Participants received investigational medicinal products for up to 4-weeks followed by a 28 day follow-up period.
Participant milestones
| Measure |
LEO 29102 Vehicle
LEO 29102 cream vehicle applied topically twice daily - in the morning and in the evening - on a total area of 3-10% of the total body surface area (BSA) for up to 4 weeks. Participants who were evaluated by the investigator to be symptom-free (as defined by an investigator's global assessment \[IGA\] of 0 or 1, i.e. clear or almost clear of symptoms) at any of Visits 2(Day 7), 3(Day 14) or 4(Day 21) could stop treatment at the investigator's discretion. They were to remain in the study and attend all visits up to and including Visit 6 (Day 56). The participants had to have study medication dispensed and should restart treatment if required, based on the participant's own judgement. More than one discontinuation/restart cycle was allowed.
|
LEO 29102 0.03 mg/g
LEO 29102 0.03 mg/g cream applied topically twice daily - in the morning and in the evening - on a total area of 3-10% of the total BSA for up to 4 weeks. Participants who were evaluated by the investigator to be symptom-free (as defined by an IGA of 0 or 1, i.e. clear or almost clear of symptoms) at any of Visits 2(Day 7), 3(Day 14) or 4(Day 21) could stop treatment at the investigator's discretion. They were to remain in the study and attend all visits up to and including Day 56. The participants had to have study medication dispensed and should restart treatment if required, based on the participant's own judgement. More than one discontinuation/restart cycle was allowed.
|
LEO 29102 0.1 mg/g
LEO 29102 0.1 mg/g cream applied topically twice daily - in the morning and in the evening - on a total area of 3-10% of the total BSA for up to 4 weeks. Participants who were evaluated by the investigator to be symptom-free (as defined by an IGA of 0 or 1) at any of Visits 2(Day 7), 3(Day 14) or 4(Day 21) could stop treatment at the investigator's discretion. They were to remain in the study and attend all visits up to and including Day 56. The participants had to have study medication dispensed and should restart treatment if required, based on the participant's own judgement. More than one discontinuation/restart cycle was allowed.
|
LEO 29102 0.3 mg/g
LEO 29102 0.3 mg/g cream applied topically twice daily - in the morning and in the evening - on a total area of 3-10% of the total BSA for up to 4 weeks. Participants who were evaluated by the investigator to be symptom-free (as defined by an IGA of 0 or 1) at any of Visits 2(Day 7), 3(Day 14) or 4(Day 21) could stop treatment at the investigator's discretion. They were to remain in the study and attend all visits up to and including Day 56. The participants had to have study medication dispensed and should restart treatment if required, based on the participant's own judgement. More than one discontinuation/restart cycle was allowed.
|
LEO 29102 1.0 mg/g
LEO 29102 1.0 mg/g cream applied topically twice daily - in the morning and in the evening - on a total area of 3-10% of the total BSA for up to 4 weeks. Participants who were evaluated by the investigator to be symptom-free (as defined by an IGA of 0 or 1) at any of Visits 2(Day 7), 3(Day 14) or 4(Day 21) could stop treatment at the investigator's discretion. They were to remain in the study and attend all visits up to and including Day 56. The participant had to have study medication dispensed and should restart treatment if required, based on the participant's own judgement. More than one discontinuation/restart cycle was allowed.
Participants were not randomized to this treatment until the results from the hormone screen blood samples from at least 10 participants in each of the five initial treatment arms (LEO 29102 0.03 mg/g cream, 0.1 mg/g cream,0.3 mg/g cream, cream vehicle, and Elidel®) were available and no safety concerns had been raised.
|
LEO 29102 2.5 mg/g
LEO 29102 2.5 mg/g cream applied topically twice daily - in the morning and in the evening - on a total area of 3-10% of the total BSA for up to 4 weeks. Participants who were evaluated by the investigator to be symptom-free (as defined by an IGA of 0 or 1) at any of Visits 2(Day 7), 3(Day 14) or 4(Day 21) could stop treatment at the investigator's discretion. They were to remain in the study and attend all visits up to and including Day 56. The participants had to have study medication dispensed and should restart treatment if required, based on the participant's own judgement. More than one discontinuation/restart cycle was allowed.
Participants were not randomized to this treatment until the results from the hormone screen blood samples from at least 10 participants in each of the five initial treatment arms (LEO 29102 0.03 mg/g cream, 0.1 mg/g cream,0.3 mg/g cream, cream vehicle, and Elidel®) were available and no safety concerns had been raised.
|
Elidel® 10 mg/g
Elidel® applied topically twice daily - in the morning and in the evening - on a total area of 3-10% of the total BSA for up to 4 weeks.
Participants who were evaluated by the investigator to be symptom-free (as defined by an IGA of 0 or 1) at any of Visits 2(Day 7), 3(Day 14) or 4(Day 21) could stop treatment at the investigator's discretion. They were to remain in the study and attend all visits up to and including Day 56. The participants had to have study medication dispensed and should restart treatment if required, based on the participant's own judgement. More than one discontinuation/restart cycle was allowed.
|
|---|---|---|---|---|---|---|---|
|
Overall Study
STARTED
|
25
|
24
|
25
|
25
|
29
|
30
|
25
|
|
Overall Study
COMPLETED
|
19
|
22
|
22
|
24
|
26
|
27
|
23
|
|
Overall Study
NOT COMPLETED
|
6
|
2
|
3
|
1
|
3
|
3
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
LEO 29102 Cream in the Treatment of Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
LEO 29102 Vehicle
n=25 Participants
Treatment with LEO 29102 cream vehicle twice daily - in the morning and in the evening - for up to 4 weeks
|
LEO 29102 0.03 mg/g
n=24 Participants
Treatment with LEO 29102 0.03 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks
|
LEO 29102 0.1 mg/g
n=25 Participants
Treatment with LEO 29102 0.1 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks
|
LEO 29102 0.3 mg/g
n=25 Participants
Treatment with LEO 29102 0.3 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks
|
LEO 29102 1.0 mg/g
n=29 Participants
Treatment with LEO 29102 1.0 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks
|
LEO 29102 2.5 mg/g
n=30 Participants
Treatment with LEO 29102 2.5 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks
|
Elidel® 10 mg/g
n=25 Participants
Treatment with Elidel® twice daily - in the morning and in the evening - for up to 4 weeks
|
Total
n=183 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|---|---|
|
Age, Continuous
|
39.1 years
STANDARD_DEVIATION 14.0 • n=5 Participants
|
36.2 years
STANDARD_DEVIATION 14.4 • n=7 Participants
|
34.9 years
STANDARD_DEVIATION 11.8 • n=5 Participants
|
38.3 years
STANDARD_DEVIATION 12.6 • n=4 Participants
|
32.0 years
STANDARD_DEVIATION 10.0 • n=21 Participants
|
35.5 years
STANDARD_DEVIATION 13.7 • n=8 Participants
|
29.9 years
STANDARD_DEVIATION 8.8 • n=8 Participants
|
35.1 years
STANDARD_DEVIATION 12.5 • n=24 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
13 Participants
n=8 Participants
|
9 Participants
n=8 Participants
|
70 Participants
n=24 Participants
|
|
Sex: Female, Male
Male
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
21 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
17 Participants
n=8 Participants
|
16 Participants
n=8 Participants
|
113 Participants
n=24 Participants
|
|
Region of Enrollment
Canada
|
4 participants
n=5 Participants
|
6 participants
n=7 Participants
|
5 participants
n=5 Participants
|
6 participants
n=4 Participants
|
6 participants
n=21 Participants
|
6 participants
n=8 Participants
|
4 participants
n=8 Participants
|
37 participants
n=24 Participants
|
|
Region of Enrollment
Finland
|
3 participants
n=5 Participants
|
0 participants
n=7 Participants
|
2 participants
n=5 Participants
|
2 participants
n=4 Participants
|
6 participants
n=21 Participants
|
6 participants
n=8 Participants
|
3 participants
n=8 Participants
|
22 participants
n=24 Participants
|
|
Region of Enrollment
Germany
|
18 participants
n=5 Participants
|
18 participants
n=7 Participants
|
18 participants
n=5 Participants
|
17 participants
n=4 Participants
|
17 participants
n=21 Participants
|
18 participants
n=8 Participants
|
18 participants
n=8 Participants
|
124 participants
n=24 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 0) and end of treatment (Day 28)The EASI is a composite score based on the evaluation of four characteristic atopic dermatitis (AD) signs and symptoms; erythema, oedema/induration/papulation, excoriation and lichenification together with the area involved. For each body region, the investigator rated four clinical signs of AD using the following severity scale: 0 = none/absent 1. = mild 2. = moderate 3. = severe The EASI score ranges from 0-12, a higher score equals a worse outcome. Baseline was defined as Day 0. Mean values in table are least squares mean adjusted for the effect of (pooled) country.
Outcome measures
| Measure |
LEO 29102 Vehicle
n=25 Participants
Treatment with LEO 29102 cream vehicle twice daily - in the morning and in the evening - for up to 4 weeks
|
LEO 29102 0.03 mg/g
n=24 Participants
Treatment with LEO 29102 0.03 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks
|
LEO 29102 0.1 mg/g
n=25 Participants
Treatment with LEO 29102 0.1 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks
|
LEO 29102 0.3 mg/g
n=25 Participants
Treatment with LEO 29102 0.3 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks
|
LEO 29102 1.0 mg/g
n=29 Participants
Treatment with LEO 29102 1.0 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks
|
LEO 29102 2.5 mg/g
n=30 Participants
Treatment with LEO 29102 2.5 mg/g cream twice daily - in the morning and in the evening - for up to 4 week
|
Elidel® 10 mg/g
n=25 Participants
Treatment with Elidel® twice daily - in the morning and in the evening - for up to 4 weeks
|
|---|---|---|---|---|---|---|---|
|
Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline (Last Observation Carried Forward [LOCF])
|
-0.85 units on a scale
Standard Deviation 6.85
|
-2.13 units on a scale
Standard Deviation 3.00
|
-1.09 units on a scale
Standard Deviation 5.81
|
-2.86 units on a scale
Standard Deviation 2.99
|
-2.41 units on a scale
Standard Deviation 2.38
|
-2.50 units on a scale
Standard Deviation 3.28
|
-3.30 units on a scale
Standard Deviation 2.51
|
SECONDARY outcome
Timeframe: At end of treatment (Day 28)The IGA (Investigator's global assessment) of disease severity on the body (trunk and limbs excluding the hands) was assessed based on visual evaluation by use of the following definitions of severity: 0\. Clear - no inflammatory signs of AD 1. Almost clear - just perceptible erythema, and just perceptible papulation/infiltration 2. Mild - mild erythema, and mild papulation/infiltration 3. Moderate - moderate erythema, and moderate papulation/infiltration 4. Severe - severe erythema, and-severe papulation/infiltration 5. Very severe - severe erythema, and severe papulation/infiltration with oozing/crusting. Symptom free responders were defined as an IGA of 0 (Clear) or 1 (Almost clear) at the end of treatment.
Outcome measures
| Measure |
LEO 29102 Vehicle
n=25 Participants
Treatment with LEO 29102 cream vehicle twice daily - in the morning and in the evening - for up to 4 weeks
|
LEO 29102 0.03 mg/g
n=24 Participants
Treatment with LEO 29102 0.03 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks
|
LEO 29102 0.1 mg/g
n=25 Participants
Treatment with LEO 29102 0.1 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks
|
LEO 29102 0.3 mg/g
n=25 Participants
Treatment with LEO 29102 0.3 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks
|
LEO 29102 1.0 mg/g
n=29 Participants
Treatment with LEO 29102 1.0 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks
|
LEO 29102 2.5 mg/g
n=30 Participants
Treatment with LEO 29102 2.5 mg/g cream twice daily - in the morning and in the evening - for up to 4 week
|
Elidel® 10 mg/g
n=25 Participants
Treatment with Elidel® twice daily - in the morning and in the evening - for up to 4 weeks
|
|---|---|---|---|---|---|---|---|
|
Number of Participants That Were Symptom Free Responders (LOCF)
Responder
|
6 Participants
|
2 Participants
|
5 Participants
|
9 Participants
|
10 Participants
|
13 Participants
|
12 Participants
|
|
Number of Participants That Were Symptom Free Responders (LOCF)
Non-responder
|
19 Participants
|
22 Participants
|
20 Participants
|
16 Participants
|
19 Participants
|
17 Participants
|
13 Participants
|
SECONDARY outcome
Timeframe: At end of treatment (Day 28)Participants' assessment of pruritus on trunk and limbs was assessed at end of treatment by use of the scale below. * Absent - no itching * Mild - occasional, slight itching * Moderate - constant or intermittent itching which is not disturbing sleep * Severe - intolerable itching which is disturbing sleep The assessment was based on the average degree of pruritus over the last 24 hours.
Outcome measures
| Measure |
LEO 29102 Vehicle
n=25 Participants
Treatment with LEO 29102 cream vehicle twice daily - in the morning and in the evening - for up to 4 weeks
|
LEO 29102 0.03 mg/g
n=24 Participants
Treatment with LEO 29102 0.03 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks
|
LEO 29102 0.1 mg/g
n=25 Participants
Treatment with LEO 29102 0.1 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks
|
LEO 29102 0.3 mg/g
n=25 Participants
Treatment with LEO 29102 0.3 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks
|
LEO 29102 1.0 mg/g
n=29 Participants
Treatment with LEO 29102 1.0 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks
|
LEO 29102 2.5 mg/g
n=30 Participants
Treatment with LEO 29102 2.5 mg/g cream twice daily - in the morning and in the evening - for up to 4 week
|
Elidel® 10 mg/g
n=25 Participants
Treatment with Elidel® twice daily - in the morning and in the evening - for up to 4 weeks
|
|---|---|---|---|---|---|---|---|
|
Participants' Assessment of Pruritus on Trunk and Limbs
Absent
|
5 Participants
|
1 Participants
|
4 Participants
|
7 Participants
|
5 Participants
|
7 Participants
|
6 Participants
|
|
Participants' Assessment of Pruritus on Trunk and Limbs
Mild
|
8 Participants
|
7 Participants
|
9 Participants
|
7 Participants
|
15 Participants
|
13 Participants
|
14 Participants
|
|
Participants' Assessment of Pruritus on Trunk and Limbs
Moderate
|
8 Participants
|
9 Participants
|
9 Participants
|
11 Participants
|
8 Participants
|
6 Participants
|
4 Participants
|
|
Participants' Assessment of Pruritus on Trunk and Limbs
Severe
|
4 Participants
|
7 Participants
|
3 Participants
|
0 Participants
|
1 Participants
|
4 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: At end of treatment (Day 28)Participants' overall assessment of disease severity on trunk and limbs (excluding the hands) was assessed at end of treatment by use of the following scale: clear, very mild, mild, moderate, severe. The assessment was based on the condition of the disease at the time of the evaluation and not in relation to the condition at a previous visit.
Outcome measures
| Measure |
LEO 29102 Vehicle
n=25 Participants
Treatment with LEO 29102 cream vehicle twice daily - in the morning and in the evening - for up to 4 weeks
|
LEO 29102 0.03 mg/g
n=24 Participants
Treatment with LEO 29102 0.03 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks
|
LEO 29102 0.1 mg/g
n=25 Participants
Treatment with LEO 29102 0.1 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks
|
LEO 29102 0.3 mg/g
n=25 Participants
Treatment with LEO 29102 0.3 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks
|
LEO 29102 1.0 mg/g
n=29 Participants
Treatment with LEO 29102 1.0 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks
|
LEO 29102 2.5 mg/g
n=30 Participants
Treatment with LEO 29102 2.5 mg/g cream twice daily - in the morning and in the evening - for up to 4 week
|
Elidel® 10 mg/g
n=25 Participants
Treatment with Elidel® twice daily - in the morning and in the evening - for up to 4 weeks
|
|---|---|---|---|---|---|---|---|
|
Participants' Overall Assessment of Disease Severity
Clear
|
2 Participants
|
1 Participants
|
2 Participants
|
3 Participants
|
4 Participants
|
1 Participants
|
2 Participants
|
|
Participants' Overall Assessment of Disease Severity
Very mild
|
5 Participants
|
1 Participants
|
4 Participants
|
5 Participants
|
5 Participants
|
12 Participants
|
11 Participants
|
|
Participants' Overall Assessment of Disease Severity
Moderate
|
6 Participants
|
9 Participants
|
7 Participants
|
11 Participants
|
10 Participants
|
4 Participants
|
3 Participants
|
|
Participants' Overall Assessment of Disease Severity
Severe
|
4 Participants
|
3 Participants
|
3 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Participants' Overall Assessment of Disease Severity
Mild
|
8 Participants
|
10 Participants
|
9 Participants
|
5 Participants
|
10 Participants
|
10 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: At Visit 2 (Day 7), Visit 3 (Day 14), Visit 4 (Day 21) and end of treatment (Day 28)Population: Occurrences of early withdrawal, non-compliance, prohibited medication, missing application of study medication and participants missing visits resulted in not all participants being analyzed at all visits.
Symptom free responders were defined as an IGA of 0 (Clear) or 1 (Almost clear) according to Investigator's global assessment of disease severity on trunk and limbs at the end of treatment.
Outcome measures
| Measure |
LEO 29102 Vehicle
n=25 Participants
Treatment with LEO 29102 cream vehicle twice daily - in the morning and in the evening - for up to 4 weeks
|
LEO 29102 0.03 mg/g
n=24 Participants
Treatment with LEO 29102 0.03 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks
|
LEO 29102 0.1 mg/g
n=25 Participants
Treatment with LEO 29102 0.1 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks
|
LEO 29102 0.3 mg/g
n=25 Participants
Treatment with LEO 29102 0.3 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks
|
LEO 29102 1.0 mg/g
n=29 Participants
Treatment with LEO 29102 1.0 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks
|
LEO 29102 2.5 mg/g
n=30 Participants
Treatment with LEO 29102 2.5 mg/g cream twice daily - in the morning and in the evening - for up to 4 week
|
Elidel® 10 mg/g
n=25 Participants
Treatment with Elidel® twice daily - in the morning and in the evening - for up to 4 weeks
|
|---|---|---|---|---|---|---|---|
|
Number of Participants That Were Symptom Free Responders by Visit
Visit 2 (Day 7) · Responder
|
2 Participants
|
1 Participants
|
2 Participants
|
1 Participants
|
5 Participants
|
5 Participants
|
2 Participants
|
|
Number of Participants That Were Symptom Free Responders by Visit
Visit 2 (Day 7) · Non-responder
|
23 Participants
|
22 Participants
|
23 Participants
|
23 Participants
|
23 Participants
|
25 Participants
|
23 Participants
|
|
Number of Participants That Were Symptom Free Responders by Visit
Visit 3 (Day 14) · Responder
|
4 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
5 Participants
|
7 Participants
|
8 Participants
|
|
Number of Participants That Were Symptom Free Responders by Visit
Visit 3 (Day 14) · Non-responder
|
17 Participants
|
23 Participants
|
20 Participants
|
21 Participants
|
22 Participants
|
22 Participants
|
16 Participants
|
|
Number of Participants That Were Symptom Free Responders by Visit
Visit 4 (Day 21) · Non-responder
|
16 Participants
|
20 Participants
|
17 Participants
|
16 Participants
|
20 Participants
|
16 Participants
|
15 Participants
|
|
Number of Participants That Were Symptom Free Responders by Visit
Visit 5 (Day 28) · Responder
|
6 Participants
|
2 Participants
|
5 Participants
|
9 Participants
|
10 Participants
|
12 Participants
|
12 Participants
|
|
Number of Participants That Were Symptom Free Responders by Visit
Visit 4 (Day 21) · Responder
|
4 Participants
|
2 Participants
|
6 Participants
|
7 Participants
|
5 Participants
|
11 Participants
|
8 Participants
|
|
Number of Participants That Were Symptom Free Responders by Visit
Visit 5 (Day 28) · Non-responder
|
13 Participants
|
20 Participants
|
17 Participants
|
15 Participants
|
16 Participants
|
15 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: Baseline and at Visit 2 (Day 7), Visit 3 (Day 14), Visit 4 (Day 21)Population: Data was tabulated using an observed cases approach and therefore only contains data from participants who attended the specific visit.
The EASI is a composite score based on the evaluation of four characteristic atopic dermatitis (AD) signs and symptoms; erythema, oedema/induration/papulation, excoriation and lichenification together with the area involved. For each body region, the investigator rated four clinical signs of AD using the following severity scale: 0 = none/absent 1. = mild 2. = moderate 3. = severe The EASI score ranges from 0-12, a higher score equals a worse outcome. Baseline was defined as Day 0. Mean values in table are least squares mean adjusted for the effect of (pooled) country.
Outcome measures
| Measure |
LEO 29102 Vehicle
n=25 Participants
Treatment with LEO 29102 cream vehicle twice daily - in the morning and in the evening - for up to 4 weeks
|
LEO 29102 0.03 mg/g
n=24 Participants
Treatment with LEO 29102 0.03 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks
|
LEO 29102 0.1 mg/g
n=25 Participants
Treatment with LEO 29102 0.1 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks
|
LEO 29102 0.3 mg/g
n=25 Participants
Treatment with LEO 29102 0.3 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks
|
LEO 29102 1.0 mg/g
n=29 Participants
Treatment with LEO 29102 1.0 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks
|
LEO 29102 2.5 mg/g
n=30 Participants
Treatment with LEO 29102 2.5 mg/g cream twice daily - in the morning and in the evening - for up to 4 week
|
Elidel® 10 mg/g
n=25 Participants
Treatment with Elidel® twice daily - in the morning and in the evening - for up to 4 weeks
|
|---|---|---|---|---|---|---|---|
|
Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline by Visit
Visit 3 (Day 14)
|
-1.77 units on a scale
Standard Deviation 2.77
|
-1.48 units on a scale
Standard Deviation 2.19
|
-1.30 units on a scale
Standard Deviation 2.28
|
-2.19 units on a scale
Standard Deviation 3.14
|
-1.67 units on a scale
Standard Deviation 2.15
|
-1.52 units on a scale
Standard Deviation 3.17
|
-1.82 units on a scale
Standard Deviation 2.39
|
|
Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline by Visit
Visit 4 (Day 21)
|
-1.62 units on a scale
Standard Deviation 4.18
|
-1.76 units on a scale
Standard Deviation 2.67
|
-0.89 units on a scale
Standard Deviation 5.94
|
-2.21 units on a scale
Standard Deviation 3.27
|
-1.90 units on a scale
Standard Deviation 2.57
|
-2.53 units on a scale
Standard Deviation 2.18
|
-2.16 units on a scale
Standard Deviation 2.22
|
|
Absolute Change in Eczema Area and Severity Index (EASI) Score From Baseline by Visit
Visit 2 (Day 7)
|
-0.09 units on a scale
Standard Deviation 5.27
|
-1.26 units on a scale
Standard Deviation 1.72
|
-0.93 units on a scale
Standard Deviation 1.82
|
-1.43 units on a scale
Standard Deviation 2.53
|
-1.64 units on a scale
Standard Deviation 1.71
|
-1.48 units on a scale
Standard Deviation 2.28
|
-1.21 units on a scale
Standard Deviation 2.17
|
Adverse Events
LEO 29102 Cream Vehicle - Treatment Phase
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
LEO 29102 0.03 mg/g Cream - Treatment Phase
Serious events: 0 serious events
Other events: 11 other events
Deaths: 0 deaths
LEO 29102 0.1 mg/g Cream - Treatment Phase
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
LEO 29102 0.3 mg/g Cream - Treatment Phase
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
LEO 29102 1.0 mg/g Cream - Treatment Phase
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
LEO 29102 2.5 mg/g Cream - Treatment Phase
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
Elidel® Cream (Pimecrolimus) 10 mg/g - Treatment Phase
Serious events: 0 serious events
Other events: 8 other events
Deaths: 0 deaths
LEO 29102 Cream Vehicle - Follow-up Phase
Serious events: 0 serious events
Other events: 1 other events
Deaths: 0 deaths
LEO 29102 0.03 mg/g Cream - Follow-up Phase
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
LEO 29102 0.1 mg/g Cream - Follow-up Phase
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
LEO 29102 0.3 mg/g Cream - Follow-up Phase
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
LEO 29102 1.0 mg/g Cream - Follow-up Phase
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
LEO 29102 2.5 mg/g Cream - Follow-up Phase
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
Elidel® 10 mg/g - Follow-up Phase
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LEO 29102 Cream Vehicle - Treatment Phase
n=25 participants at risk
Treatment with LEO 29102 cream vehicle twice daily - in the morning and in the evening - for up to 4 weeks
|
LEO 29102 0.03 mg/g Cream - Treatment Phase
n=24 participants at risk
Treatment with LEO 29102 0.03 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks
|
LEO 29102 0.1 mg/g Cream - Treatment Phase
n=25 participants at risk
Treatment with LEO 29102 0.1 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks
|
LEO 29102 0.3 mg/g Cream - Treatment Phase
n=25 participants at risk
Treatment with LEO 29102 0.3 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks
|
LEO 29102 1.0 mg/g Cream - Treatment Phase
n=28 participants at risk
Treatment with LEO 29102 1.0 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks
|
LEO 29102 2.5 mg/g Cream - Treatment Phase
n=30 participants at risk
Treatment with LEO 29102 2.5 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks
|
Elidel® Cream (Pimecrolimus) 10 mg/g - Treatment Phase
n=25 participants at risk
Treatment with Elidel® twice daily - in the morning and in the evening - for up to 4 weeks
|
LEO 29102 Cream Vehicle - Follow-up Phase
n=25 participants at risk
Treatment with LEO 29102 cream vehicle twice daily - in the morning and in the evening - for up to 4 weeks
|
LEO 29102 0.03 mg/g Cream - Follow-up Phase
n=24 participants at risk
Treatment with LEO 29102 0.03 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks
|
LEO 29102 0.1 mg/g Cream - Follow-up Phase
n=25 participants at risk
Treatment with LEO 29102 0.1 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks
|
LEO 29102 0.3 mg/g Cream - Follow-up Phase
n=25 participants at risk
Treatment with LEO 29102 0.3 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks
|
LEO 29102 1.0 mg/g Cream - Follow-up Phase
n=28 participants at risk
Treatment with LEO 29102 1.0 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks
|
LEO 29102 2.5 mg/g Cream - Follow-up Phase
n=30 participants at risk
Treatment with LEO 29102 2.5 mg/g cream twice daily - in the morning and in the evening - for up to 4 weeks
|
Elidel® 10 mg/g - Follow-up Phase
n=25 participants at risk
Treatment with Elidel® twice daily - in the morning and in the evening - for up to 4 weeks
|
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
|
Eye disorders
Conjunctivitis
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
3.3%
1/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
|
Eye disorders
Conjunctivitis allergic
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
3.3%
1/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
|
Eye disorders
Keratitis
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
3.6%
1/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
4.2%
1/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
3.6%
1/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
3.6%
1/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
3.6%
1/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
4.0%
1/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
4.0%
1/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
|
General disorders
Application site irritation
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
4.2%
1/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
|
General disorders
Application site pain
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
8.3%
2/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
4.0%
1/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
3.6%
1/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
4.0%
1/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
|
General disorders
Application site pruritus
|
4.0%
1/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
4.2%
1/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
4.0%
1/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
3.6%
1/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
|
General disorders
Application site vesicles
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
4.2%
1/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
|
General disorders
Influenza like illness
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
4.2%
1/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
4.0%
1/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
3.3%
1/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
|
General disorders
Pain
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
3.3%
1/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
|
Infections and infestations
Abdominal abscess
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
3.6%
1/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
|
Infections and infestations
Acute tonsillitis
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
4.0%
1/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
|
Infections and infestations
Bronchitis
|
4.0%
1/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
|
Infections and infestations
Cellulitis
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
3.6%
1/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
|
Infections and infestations
Fungal infection
|
4.0%
1/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
3.6%
1/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
4.0%
1/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
|
Infections and infestations
Gastrointestinal infection
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
4.2%
1/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
4.0%
1/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
|
Infections and infestations
Herpes simplex ophthalmic
|
4.0%
1/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
|
Infections and infestations
Nasopharyngitis
|
8.0%
2/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
8.0%
2/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
8.0%
2/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
3.6%
1/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
3.3%
1/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
12.0%
3/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
3.3%
1/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
4.2%
1/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
|
Infections and infestations
Rhinitis
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
8.0%
2/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
|
Infections and infestations
Sinusitis
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
3.6%
1/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
4.0%
1/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
4.0%
1/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
|
Infections and infestations
Wound infection
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
3.6%
1/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
3.3%
1/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
4.0%
1/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
4.0%
1/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Cholesteatoma
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
4.2%
1/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
|
Nervous system disorders
Burning sensation
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
4.0%
1/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
|
Nervous system disorders
Headache
|
4.0%
1/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
4.2%
1/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
4.0%
1/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
7.1%
2/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
|
Nervous system disorders
Migraine
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
4.0%
1/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
4.0%
1/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
|
Nervous system disorders
Paraesthesia
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
4.0%
1/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
3.6%
1/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
|
Reproductive system and breast disorders
Breast swelling
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
4.0%
1/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Asthma
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
4.0%
1/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
4.0%
1/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
3.6%
1/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Cholestatic pruritus
|
4.0%
1/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
12.0%
3/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
4.2%
1/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
12.0%
3/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
3.6%
1/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
13.3%
4/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
3.3%
1/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
4.0%
1/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
4.0%
1/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
8.0%
2/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
3.6%
1/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
4.0%
1/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Swelling face
|
4.0%
1/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
4.0%
1/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
3.3%
1/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
|
Surgical and medical procedures
Knee operation
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
4.0%
1/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
|
Surgical and medical procedures
Osteotomy
|
4.0%
1/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
|
General disorders
Local swelling
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
4.0%
1/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
|
Immune system disorders
Seasonal allergy
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
4.0%
1/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
|
Investigations
Arthroscopy
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
3.3%
1/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/24 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/28 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
0.00%
0/30 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
4.0%
1/25 • From baseline (Day 0) to Day 28±3 (end of treatment) and follow-up phase (from end of treatment to Day 56±4)
The Safety Analysis Set only consisted of participants who applied study medication. One participant from the LEO 29102 1.0 mg/g arm, did not apply any study medication and was therefore excluded from the safety analysis.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Company acknowledges the investigators' right to publish the entire results of the study, irrespective of outcome. The Company retains the right to have any publication submitted to the Company for review at least 30 days prior to the same paper being submitted for publication or presentation. Investigators must undertake not to submit any part of their individual data for publication without the prior consent of LEO.
- Publication restrictions are in place
Restriction type: OTHER