Trial Outcomes & Findings for Safety and Efficacy of Once Daily Topical Treatment With LEO 90100 Aerosol Foam in Adolescent Subjects With Plaque Psoriasis (NCT NCT02387853)
NCT ID: NCT02387853
Last Updated: 2025-03-10
Results Overview
Number of subjects with adverse events in the safety analysis set, defined by excluding subjects from the full analysis set who either received no treatment with the IMP and/or for whom no post-baseline safety evaluations are available.
COMPLETED
PHASE2
117 participants
From Week -1 to Week 8
2025-03-10
Participant Flow
117 subjects were enrolled, this number includes all subjects who provided consent for participation in the trial and were screened. Out of the 117 subjects who were screened, 106 subjects met all inclusion criteria and none of the exclusion criteria, and were started on treatment in the LEO 90100 arm.
Participant milestones
| Measure |
LEO 90100
LEO 90100, an aerosol foam formulation containing calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) was applied once daily to body and scalp psoriasis lesions.
|
|---|---|
|
Overall Study
STARTED
|
106
|
|
Overall Study
COMPLETED
|
103
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy of Once Daily Topical Treatment With LEO 90100 Aerosol Foam in Adolescent Subjects With Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
LEO 90100
n=106 Participants
LEO 90100, an aerosol foam formulation containing calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) was applied once daily to body and scalp psoriasis lesions. This arm contains all 106 subjects that were assigned to treatment and constitutes the full analysis set and the safety analysis set. 33 subjects in this arm performed additional baseline and post-baseline HPA axis assessments and constitute the per protocol analysis set.
|
|---|---|
|
Age, Continuous
|
14.2 years
STANDARD_DEVIATION 1.4 • n=5 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
45 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
103 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
102 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
Netherlands
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
Romania
|
32 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
2 Participants
n=5 Participants
|
|
Region of Enrollment
Poland
|
63 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Type I
|
5 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Type II
|
44 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Type III
|
46 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Type IV
|
10 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Type V
|
1 Participants
n=5 Participants
|
|
Height
|
165.79 cm
STANDARD_DEVIATION 9.77 • n=5 Participants
|
|
Weight
|
60.01 kg
STANDARD_DEVIATION 14.41 • n=5 Participants
|
|
Duration of plaque psoriasis
|
4.3 years
STANDARD_DEVIATION 2.9 • n=5 Participants
|
PRIMARY outcome
Timeframe: From Week -1 to Week 8Population: Safety analysis set
Number of subjects with adverse events in the safety analysis set, defined by excluding subjects from the full analysis set who either received no treatment with the IMP and/or for whom no post-baseline safety evaluations are available.
Outcome measures
| Measure |
LEO 90100
n=106 Participants
LEO 90100, an aerosol foam formulation containing calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) was applied once daily to body and scalp psoriasis lesions.
|
|---|---|
|
Number of Subjects With Adverse Events (AEs)
Upper respiratory tract infection
|
8 Participants
|
|
Number of Subjects With Adverse Events (AEs)
Nasopharyngitis
|
4 Participants
|
|
Number of Subjects With Adverse Events (AEs)
Folliculitis
|
1 Participants
|
|
Number of Subjects With Adverse Events (AEs)
Impetigo
|
1 Participants
|
|
Number of Subjects With Adverse Events (AEs)
Oral herpes
|
1 Participants
|
|
Number of Subjects With Adverse Events (AEs)
Pharyngitis
|
1 Participants
|
|
Number of Subjects With Adverse Events (AEs)
Pulpitis dental
|
1 Participants
|
|
Number of Subjects With Adverse Events (AEs)
Rhinitis
|
1 Participants
|
|
Number of Subjects With Adverse Events (AEs)
Acne
|
2 Participants
|
|
Number of Subjects With Adverse Events (AEs)
Erythema
|
1 Participants
|
|
Number of Subjects With Adverse Events (AEs)
Pruritus generalised
|
1 Participants
|
|
Number of Subjects With Adverse Events (AEs)
Psoriasis
|
1 Participants
|
|
Number of Subjects With Adverse Events (AEs)
Skin reaction
|
1 Participants
|
|
Number of Subjects With Adverse Events (AEs)
Application site pain
|
1 Participants
|
|
Number of Subjects With Adverse Events (AEs)
Product physical consistency issue
|
1 Participants
|
|
Number of Subjects With Adverse Events (AEs)
Arthralgia
|
1 Participants
|
|
Number of Subjects With Adverse Events (AEs)
Myalgia
|
1 Participants
|
|
Number of Subjects With Adverse Events (AEs)
Myopia
|
1 Participants
|
|
Number of Subjects With Adverse Events (AEs)
Arthropod bite
|
1 Participants
|
|
Number of Subjects With Adverse Events (AEs)
Haemangioma of liver
|
1 Participants
|
|
Number of Subjects With Adverse Events (AEs)
Skin neoplasm excision
|
1 Participants
|
PRIMARY outcome
Timeframe: 30 minutes after ACTH-challenge at Week 4Population: Per protocol analysis set
Number of subjects with serum cortisol concentration of ≤18 mcg/dl at 30 minutes after ACTH-challenge at Week 4 in the per protocol analysis set, defined as all subjects from the full analysis set who were in the HPA axis cohort but excluding subjects who did not receive any treatment with the IMP, did not provide any results for the HPA axis test at Week 4, or did not meet the inclusion criterion concerning evidence of normal adrenal function at baseline.
Outcome measures
| Measure |
LEO 90100
n=33 Participants
LEO 90100, an aerosol foam formulation containing calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) was applied once daily to body and scalp psoriasis lesions.
|
|---|---|
|
Number of Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 4
Serum cortisol equal to or below 18 mcg/dl
|
3 Participants
|
|
Number of Subjects With Serum Cortisol Concentration of ≤18 mcg/dl at 30 Minutes After ACTH-challenge at Week 4
Serum cortisol above 18 mcg/dl
|
30 Participants
|
PRIMARY outcome
Timeframe: From baseline to Week 4Population: Safety analysis set
Change in albumin-corrected serum calcium from baseline to Week 4 in safety analysis set. The safety analysis set, defined by excluding subjects from the full analysis set who either received no treatment with the IMP and/or for whom no post-baseline safety evaluations are available.
Outcome measures
| Measure |
LEO 90100
n=101 Participants
LEO 90100, an aerosol foam formulation containing calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) was applied once daily to body and scalp psoriasis lesions.
|
|---|---|
|
Change in Albumin-corrected Serum Calcium From Baseline to Week 4
|
-0.016 mmol/L
Standard Deviation 0.119
|
PRIMARY outcome
Timeframe: From baseline to Week 4Population: 24-hour urine HPA set
Change in calcium excretion in 24-hour urine collection from baseline to Week 4 in the 24-hour urine HPA set, defined as all subjects in the safety analysis set. The safety analysis set is defined, according to the Consolidated Trial Protocol, by excluding subjects from the full analysis set who either received no treatment with the IMP and/or for whom no post-baseline safety evaluations are available.
Outcome measures
| Measure |
LEO 90100
n=32 Participants
LEO 90100, an aerosol foam formulation containing calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) was applied once daily to body and scalp psoriasis lesions.
|
|---|---|
|
Change in Calcium Excretion in 24-hour Urine From Baseline to Week 4
|
-0.335 mmol/24hr
Standard Deviation 2.076
|
PRIMARY outcome
Timeframe: From baseline to Week 4Population: 24-hour urine in HPA set
Change in calcium:creatinine ratio in 24-hour urine collection from baseline to Week 4 in the 24-hour urine in HPA set, defined as all subjects in the safety analysis set who underwent HPA-axis testing.
Outcome measures
| Measure |
LEO 90100
n=31 Participants
LEO 90100, an aerosol foam formulation containing calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) was applied once daily to body and scalp psoriasis lesions.
|
|---|---|
|
Change in Calcium:Creatinine Ratio in 24-hour Urine From Baseline to Week 4
|
-0.2892 mmol/g
Standard Deviation 2.1185
|
SECONDARY outcome
Timeframe: 30 and 60 minutes after ACTH-challenge at Week 4Population: Per protocol analysis set
Number of subjects with serum cortisol concentration ≤18 mcg/dL at both 30 and 60 minutes after ACTH-challenge at Week 4 in the per protocol analysis set, defined as all subjects from the full analysis set who were in the HPA axis cohort but excluding subjects who did not receive any treatment with the IMP, did not provide any results for the HPA axis test at Week 4, or did not meet the inclusion criterion concerning evidence of normal adrenal function at baseline.
Outcome measures
| Measure |
LEO 90100
n=33 Participants
LEO 90100, an aerosol foam formulation containing calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) was applied once daily to body and scalp psoriasis lesions.
|
|---|---|
|
Number of Subjects With Serum Cortisol Concentration ≤18 mcg/dL at Both 30 and 60 Minutes After ACTH-challenge at Week 4
Serum cortisol equal to or below 18 mcg/dL
|
1 Participants
|
|
Number of Subjects With Serum Cortisol Concentration ≤18 mcg/dL at Both 30 and 60 Minutes After ACTH-challenge at Week 4
Serum cortisol above 18 mcg/dl
|
32 Participants
|
SECONDARY outcome
Timeframe: From baseline to Week 4Population: Spot urine non-HPA set
Change in calcium:creatinine ratio in spot urine samples from baseline to Week 4 in the spot urine non-HPA set, defined as all subjects in the safety analysis set who did not undergo HPA-axis testing.
Outcome measures
| Measure |
LEO 90100
n=48 Participants
LEO 90100, an aerosol foam formulation containing calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) was applied once daily to body and scalp psoriasis lesions.
|
|---|---|
|
Change in Calcium:Creatinine Ratio in Spot Urine Samples From Baseline to Week 4
|
0.4620 mmol/g
Standard Deviation 1.8892
|
SECONDARY outcome
Timeframe: Week 4Population: Full analysis set. 3 subjects withdrew from the trial prior to the Week 4 visit, the remaining 103 subjects were included in the analysis of this outcome measure.
Number of subjects with 'treatment success' according to Physician's Global Assessment (PGA) on Body in the full analysis set, defined as the 106 subjects assigned to treatment. Treatment success was defined as 'clear' or 'almost clear' for subjects with at least 'moderate' disease at baseline according to the PGA, and defined as 'clear' for subjects with mild disease at baseline according to the PGA.
Outcome measures
| Measure |
LEO 90100
n=103 Participants
LEO 90100, an aerosol foam formulation containing calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) was applied once daily to body and scalp psoriasis lesions.
|
|---|---|
|
Number of Subjects With 'Treatment Success' According to Physician's Global Assessment (PGA) on Body
Yes
|
74 Participants
|
|
Number of Subjects With 'Treatment Success' According to Physician's Global Assessment (PGA) on Body
No
|
29 Participants
|
SECONDARY outcome
Timeframe: Week 4Population: Full analysis set. 3 subjects withdrew from the trial prior to the Week 4 visit, the remaining 103 subjects were included in the analysis of this outcome measure.
Number of subjects with 'treatment success' according to Physician's Global Assessment (PGA) on Scalp in the full analysis set, defined as the 106 subjects assigned to treatment. Treatment success was defined as 'clear' or 'almost clear' for subjects with at least 'moderate' disease at baseline according to the PGA, and defined as 'clear' for subjects with mild disease at baseline according to the PGA.
Outcome measures
| Measure |
LEO 90100
n=103 Participants
LEO 90100, an aerosol foam formulation containing calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) was applied once daily to body and scalp psoriasis lesions.
|
|---|---|
|
Number of Subjects With 'Treatment Success' According to Physician's Global Assessment (PGA) on Scalp
Yes
|
78 Participants
|
|
Number of Subjects With 'Treatment Success' According to Physician's Global Assessment (PGA) on Scalp
No
|
25 Participants
|
SECONDARY outcome
Timeframe: From baseline to Week 4Population: Full analysis set. 3 subjects withdrew from the trial prior to the Week 4 visit, the remaining 103 subjects were included in the analysis of this outcome measure.
Percentage change in Psoriasis area and severity index (PASI) score from baseline to Week 4. Psoriasis area and severity index (PASI) assesses extent and severity of clinical signs of psoriasis vulgaris. Body surface is divided in 4 ares: head (incl. neck), arms (incl. hands), trunk (incl. flexures) and legs (incl. buttocks and feet). Each area is scored from 0-6 for extent of psoriasis and from 0-4 for redness, thickness, and scaliness, and an area PASI score is calculated. The total PASI score is calculated from each area's score. The PASI score ranges from 0 (clear skin) to 72 (maximum disease), a PASI score higher than 10 generally corresponds to moderate-to-severe disease.
Outcome measures
| Measure |
LEO 90100
n=103 Participants
LEO 90100, an aerosol foam formulation containing calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) was applied once daily to body and scalp psoriasis lesions.
|
|---|---|
|
Percentage Change in PASI From Baseline to Week 4
|
-82.05 Percentage change in PASI
Standard Deviation 17.87
|
SECONDARY outcome
Timeframe: Week 4Population: Full analysis set. 3 subjects withdrew from the trial prior to the Week 4 visit, the remaining 103 subjects were included in the analysis of this outcome measure.
Number of subjects with 'treatment success' according to the Subject's Global Assessment of disease severity on the body at Week 4 in the full analysis set, defined as the 106 subjects assigned to treatment. Treatment success was defined as 'clear' or 'very mild' according to the Subject's Global Assessment of disease severity.
Outcome measures
| Measure |
LEO 90100
n=103 Participants
LEO 90100, an aerosol foam formulation containing calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) was applied once daily to body and scalp psoriasis lesions.
|
|---|---|
|
Number of Subjects With 'Treatment Success' According to the Subject's Global Assessment of Disease Severity on the Body at Week 4
Yes
|
86 Participants
|
|
Number of Subjects With 'Treatment Success' According to the Subject's Global Assessment of Disease Severity on the Body at Week 4
No
|
17 Participants
|
SECONDARY outcome
Timeframe: Week 4Population: Full analysis set. 3 subjects withdrew from the trial prior to the Week 4 visit, the remaining 103 subjects were included in the analysis of this outcome measure.
Number of subjects with 'treatment success' according to the Subject's Global Assessment of disease severity on the scalp at Week 4 in the full analysis set, defined as the 106 subjects assigned to treatment. Treatment success was defined as 'clear' or 'very mild' according to the Subject's Global Assessment of disease severity.
Outcome measures
| Measure |
LEO 90100
n=103 Participants
LEO 90100, an aerosol foam formulation containing calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) was applied once daily to body and scalp psoriasis lesions.
|
|---|---|
|
Number of Subjects With 'Treatment Success' According to the Subject's Global Assessment of Disease Severity on the Scalp at Week 4
Yes
|
84 Participants
|
|
Number of Subjects With 'Treatment Success' According to the Subject's Global Assessment of Disease Severity on the Scalp at Week 4
No
|
19 Participants
|
SECONDARY outcome
Timeframe: From baseline to Week 4Population: Full analysis set. 3 subjects withdrew from the trial prior to the Week 4 visit, the remaining 103 subjects were included in the analysis of this outcome measure.
Change in itch as assessed on a visual analog scale (VAS) from baseline to Week 4 in the full analysis set, defined as the 106 subjects assigned to treatment. The assessments were made on a 100 mm (100 mm = 10 cm) horizontal VAS anchored at 0 ('no itch at all') and 10 ('worst itch you can imagine'). Subjects were asked to put a vertical line on the scale at the spot he/she felt best reflected the maximal itch intensity during the last 24 hours. The distance from 0 to the subject's indication line was measured in mm, thus higher scores indicated a worse outcome.
Outcome measures
| Measure |
LEO 90100
n=103 Participants
LEO 90100, an aerosol foam formulation containing calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) was applied once daily to body and scalp psoriasis lesions.
|
|---|---|
|
Change in Itch as Assessed on a Visual Analog Scale (VAS) From Baseline to Week 4
|
-32.5 mm on VAS scale
Standard Deviation 27.3
|
Adverse Events
LEO 90100
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
LEO 90100
n=106 participants at risk
LEO 90100, an aerosol foam formulation containing calcipotriol 50 mcg/g (as hydrate) and betamethasone 0.5 mg/g (as dipropionate) was applied once daily to body and scalp psoriasis lesions. This arm contains all 106 subjects that were assigned to treatment and constitutes the full analysis set and the safety analysis set. 33 subjects in this arm performed additional HPA axis assessments and constitute the per protocol analysis set.
|
|---|---|
|
Infections and infestations
Upper respiratory tract infection
|
7.5%
8/106 • Number of events 8 • From Day -28 up to Day 56
During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
|
|
Infections and infestations
Nasopharyngitis
|
3.8%
4/106 • Number of events 4 • From Day -28 up to Day 56
During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
|
|
Infections and infestations
Folliculitis
|
0.94%
1/106 • Number of events 1 • From Day -28 up to Day 56
During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
|
|
Infections and infestations
Impetigo
|
0.94%
1/106 • Number of events 1 • From Day -28 up to Day 56
During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
|
|
Infections and infestations
Oral herpes
|
0.94%
1/106 • Number of events 1 • From Day -28 up to Day 56
During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
|
|
Infections and infestations
Pharyngitis
|
0.94%
1/106 • Number of events 1 • From Day -28 up to Day 56
During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
|
|
Infections and infestations
Pulpitis dental
|
0.94%
1/106 • Number of events 1 • From Day -28 up to Day 56
During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
|
|
Infections and infestations
Rhinitis
|
0.94%
1/106 • Number of events 1 • From Day -28 up to Day 56
During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
|
|
Skin and subcutaneous tissue disorders
Acne
|
1.9%
2/106 • Number of events 2 • From Day -28 up to Day 56
During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
|
|
Skin and subcutaneous tissue disorders
Erythema
|
0.94%
1/106 • Number of events 1 • From Day -28 up to Day 56
During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
|
|
Skin and subcutaneous tissue disorders
Pruritus generalised
|
0.94%
1/106 • Number of events 1 • From Day -28 up to Day 56
During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
0.94%
1/106 • Number of events 1 • From Day -28 up to Day 56
During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
|
|
Skin and subcutaneous tissue disorders
Skin reaction
|
0.94%
1/106 • Number of events 1 • From Day -28 up to Day 56
During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
|
|
General disorders
Application site pain
|
0.94%
1/106 • Number of events 1 • From Day -28 up to Day 56
During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
|
|
General disorders
Product physical consistency issue
|
0.94%
1/106 • Number of events 1 • From Day -28 up to Day 56
During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.94%
1/106 • Number of events 1 • From Day -28 up to Day 56
During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.94%
1/106 • Number of events 1 • From Day -28 up to Day 56
During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
|
|
Eye disorders
Myopia
|
0.94%
1/106 • Number of events 1 • From Day -28 up to Day 56
During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
0.94%
1/106 • Number of events 1 • From Day -28 up to Day 56
During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
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Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Haemangioma of liver
|
0.94%
1/106 • Number of events 1 • From Day -28 up to Day 56
During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
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Surgical and medical procedures
Skin neoplasm excision
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0.94%
1/106 • Number of events 1 • From Day -28 up to Day 56
During the trial, the investigator followed up all AEs (SAEs) until the final outcome was determined. After a subject had left the trial, the investigator followed up all non-serious AEs classified as possibly or probably related to the IMP for 14± 2 days or until the final outcome was determined, whichever came first. SAEs were followed up until a final outcome had been determined, that is, the follow-up could continue beyond the end of the trial.
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee LEO acknowledges the investigators' right to publish the entire results of the study, irrespective of outcome. LEO retains the right to have any publication submitted to LEO for review. 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