Trial Outcomes & Findings for Safety and Efficacy of Azelaic Acid Foam, 15 % in Papulopustular Rosacea (NCT NCT01555463)
NCT ID: NCT01555463
Last Updated: 2023-06-09
Results Overview
Static evaluation of overall severity of papulopustular rosacea at a given time: 1) Clear: no papules and/or pustules; no erythema; 2) Minimal: rare papules and/or pustules; faint up to but not including mild erythema; 3) Mild: few papules and/or pustules; mild erythema; 4) Moderate: pronounced number of papules and/or pustules (but less than numerous papules and/or pustules); moderate erythema; 5) Severe: numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate to severe erythema. Therapeutic success is defined as an IGA score of clear or minimal.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
961 participants
Primary outcome timeframe
At end of treatment (LOCF), up to 12 weeks
Results posted on
2023-06-09
Participant Flow
Participant milestones
| Measure |
Azelaic Acid Foam, 15% (BAY39-6251)
0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
|
Vehicle Foam
0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
|
|---|---|---|
|
Treatment
STARTED
|
483
|
478
|
|
Treatment
COMPLETED
|
419
|
399
|
|
Treatment
NOT COMPLETED
|
64
|
79
|
|
Follow up
STARTED
|
447
|
439
|
|
Follow up
COMPLETED
|
409
|
394
|
|
Follow up
NOT COMPLETED
|
38
|
45
|
Reasons for withdrawal
| Measure |
Azelaic Acid Foam, 15% (BAY39-6251)
0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
|
Vehicle Foam
0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
|
|---|---|---|
|
Treatment
Adverse Event
|
6
|
12
|
|
Treatment
Withdrawal by Subject
|
24
|
36
|
|
Treatment
Lost to Follow-up
|
28
|
23
|
|
Treatment
Protocol Violation
|
4
|
5
|
|
Treatment
Other reason
|
2
|
3
|
|
Follow up
Adverse Event
|
2
|
5
|
|
Follow up
Death
|
0
|
1
|
|
Follow up
Withdrawal by Subject
|
22
|
22
|
|
Follow up
Lost to Follow-up
|
9
|
10
|
|
Follow up
Protocol Violation
|
2
|
4
|
|
Follow up
Other reason
|
3
|
3
|
Baseline Characteristics
Safety and Efficacy of Azelaic Acid Foam, 15 % in Papulopustular Rosacea
Baseline characteristics by cohort
| Measure |
Azelaic Acid Foam, 15% (BAY39-6251)
n=483 Participants
0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
|
Vehicle Foam
n=478 Participants
0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
|
Total
n=961 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.2 Years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
51.9 Years
STANDARD_DEVIATION 13.2 • n=7 Participants
|
51.5 Years
STANDARD_DEVIATION 12.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
354 Participants
n=5 Participants
|
348 Participants
n=7 Participants
|
702 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
129 Participants
n=5 Participants
|
130 Participants
n=7 Participants
|
259 Participants
n=5 Participants
|
|
Investigator's Global Assessment (IGA)
Clear
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Investigator's Global Assessment (IGA)
Minimal
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Investigator's Global Assessment (IGA)
Mild
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Investigator's Global Assessment (IGA)
Moderate
|
418 Participants
n=5 Participants
|
416 Participants
n=7 Participants
|
834 Participants
n=5 Participants
|
|
Investigator's Global Assessment (IGA)
Severe
|
65 Participants
n=5 Participants
|
62 Participants
n=7 Participants
|
127 Participants
n=5 Participants
|
|
Lesion count
|
21.7 Inflammatory lesions
STANDARD_DEVIATION 9.1 • n=5 Participants
|
21.2 Inflammatory lesions
STANDARD_DEVIATION 8.7 • n=7 Participants
|
21.4 Inflammatory lesions
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Erythema rating
Clear or almost clear
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Erythema rating
Mild
|
43 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
82 Participants
n=5 Participants
|
|
Erythema rating
Moderate
|
364 Participants
n=5 Participants
|
370 Participants
n=7 Participants
|
734 Participants
n=5 Participants
|
|
Erythema rating
Severe
|
76 Participants
n=5 Participants
|
69 Participants
n=7 Participants
|
145 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At end of treatment (LOCF), up to 12 weeksPopulation: All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline.
Static evaluation of overall severity of papulopustular rosacea at a given time: 1) Clear: no papules and/or pustules; no erythema; 2) Minimal: rare papules and/or pustules; faint up to but not including mild erythema; 3) Mild: few papules and/or pustules; mild erythema; 4) Moderate: pronounced number of papules and/or pustules (but less than numerous papules and/or pustules); moderate erythema; 5) Severe: numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate to severe erythema. Therapeutic success is defined as an IGA score of clear or minimal.
Outcome measures
| Measure |
Azelaic Acid Foam, 15% (BAY39-6251)
n=483 Participants
0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
|
Vehicle Foam
n=478 Participants
0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
|
|---|---|---|
|
Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Success at End of Treatment (LOCF: Last Observation Carried Forward)
|
32.1 Percentage of participants
|
23.4 Percentage of participants
|
PRIMARY outcome
Timeframe: Baseline and end of treatment (LOCF), up to 12 weeksPopulation: All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline.
The mean (standard deviation) change from baseline in the inflammatory lesion count at the end of treatment is provided.
Outcome measures
| Measure |
Azelaic Acid Foam, 15% (BAY39-6251)
n=483 Participants
0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
|
Vehicle Foam
n=478 Participants
0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
|
|---|---|---|
|
Nominal Change From Baseline in Inflammatory Lesion (IL) Count at End of Treatment (LOCF)
|
-13.2 Inflammatory lesions
Standard Deviation 9.5
|
-10.3 Inflammatory lesions
Standard Deviation 9.8
|
SECONDARY outcome
Timeframe: Baseline and end of treatment (LOCF), up to 12 weeksPopulation: All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline.
The mean (standard deviation) percentage change in inflammatory lesion count from baseline to end of study is provided.
Outcome measures
| Measure |
Azelaic Acid Foam, 15% (BAY39-6251)
n=483 Participants
0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
|
Vehicle Foam
n=478 Participants
0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
|
|---|---|---|
|
Percent Change From Baseline in Inflammatory Lesion Count at End of Treatment (LOCF)
|
-61.6 Percent change of inflammatory lesions
Standard Deviation 33.5
|
-50.8 Percent change of inflammatory lesions
Standard Deviation 40.0
|
SECONDARY outcome
Timeframe: At end of treatment (LOCF), up to 12 weeksPopulation: All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline.
Participants achieving a clear, minimal, or mild IGA at the end of treatment were considered as 'responder'. Participants with an IGA of moderate or severe at the end of treatment were considered as 'non-responder'. Participants who prematurely withdraw from study treatment because of lack of efficacy were coded as 'non-responders'. The percentage of responders is presented.
Outcome measures
| Measure |
Azelaic Acid Foam, 15% (BAY39-6251)
n=483 Participants
0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
|
Vehicle Foam
n=478 Participants
0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
|
|---|---|---|
|
Percentage of Participants With Investigator's Global Assessment (IGA) Based Therapeutic Response at End of Treatment (LOCF)
|
66.3 Percentage of participants
|
54.4 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and end of treatment (LOCF), up to 12 weeksPopulation: All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline.
Erythema was rated as: clear or almost clear; mild; moderate; or severe. For the assessment of the grouped change in erythema ratings, the baseline examination was used to group into 'improved', 'no change', or 'worsened'. A participant was considered to have an 'improved' erythema rating if the erythema rating was lower compared to the baseline rating, 'no change' if the rating was identical, and 'worsened' if the rating was higher. The percentage of participants in each of these categories is presented.
Outcome measures
| Measure |
Azelaic Acid Foam, 15% (BAY39-6251)
n=483 Participants
0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
|
Vehicle Foam
n=478 Participants
0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
|
|---|---|---|
|
Grouped Changes From Baseline in Erythema Intensity Score at End of Treatment (LOCF)
Improved
|
61.5 Percentage of participants
|
51.3 Percentage of participants
|
|
Grouped Changes From Baseline in Erythema Intensity Score at End of Treatment (LOCF)
No change
|
36.9 Percentage of participants
|
46.2 Percentage of participants
|
|
Grouped Changes From Baseline in Erythema Intensity Score at End of Treatment (LOCF)
Worse
|
1.7 Percentage of participants
|
2.5 Percentage of participants
|
SECONDARY outcome
Timeframe: At end of treatment (LOCF), up to 12 weeksPopulation: All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline.
The IGA consists of 5 scores: 1) Clear: no papules and/or pustules; no erythema; 2) Minimal: rare papules and/or pustules; faint up to but not including mild erythema; 3) Mild: few papules and/or pustules; mild erythema; 4) Moderate: pronounced number of papules and/or pustules (but less than numerous papules and/or pustules); moderate erythema; 5) Severe: numerous papules and/or pustules, occasionally with confluent areas of inflamed lesions; moderate to severe erythema. The percentage of participants with each score at the end of treatment is provided.
Outcome measures
| Measure |
Azelaic Acid Foam, 15% (BAY39-6251)
n=483 Participants
0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
|
Vehicle Foam
n=478 Participants
0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
|
|---|---|---|
|
Percentage of Participants With Investigator's Global Assessment (IGA) Scores at End of Treatment (LOCF)
Clear
|
4.6 Percentage of participants
|
4.4 Percentage of participants
|
|
Percentage of Participants With Investigator's Global Assessment (IGA) Scores at End of Treatment (LOCF)
Minimal
|
27.5 Percentage of participants
|
19.0 Percentage of participants
|
|
Percentage of Participants With Investigator's Global Assessment (IGA) Scores at End of Treatment (LOCF)
Mild
|
34.2 Percentage of participants
|
31.0 Percentage of participants
|
|
Percentage of Participants With Investigator's Global Assessment (IGA) Scores at End of Treatment (LOCF)
Moderate
|
30.2 Percentage of participants
|
38.7 Percentage of participants
|
|
Percentage of Participants With Investigator's Global Assessment (IGA) Scores at End of Treatment (LOCF)
Severe
|
3.5 Percentage of participants
|
6.9 Percentage of participants
|
SECONDARY outcome
Timeframe: At end of treatment (LOCF), up to 12 weeksPopulation: All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline.
The mean (standard deviation) lesion count at the end of treatment is provided.
Outcome measures
| Measure |
Azelaic Acid Foam, 15% (BAY39-6251)
n=483 Participants
0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
|
Vehicle Foam
n=478 Participants
0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
|
|---|---|---|
|
Nominal Value of Inflammatory Lesion Count at End of Treatment (LOCF)
|
8.5 Inflammatory lesions
Standard Deviation 8.9
|
10.8 Inflammatory lesions
Standard Deviation 11.3
|
SECONDARY outcome
Timeframe: At end of treatment (LOCF), up to 12 weeksPopulation: All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline.
The percentage of participants in each rating category of erythema (clear or almost clear; mild; moderate; severe) at the end of treatment is provided.
Outcome measures
| Measure |
Azelaic Acid Foam, 15% (BAY39-6251)
n=483 Participants
0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
|
Vehicle Foam
n=478 Participants
0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
|
|---|---|---|
|
Percentage of Participants With Erythema Intensity Score at End of Treatment (LOCF)
Clear or almost clear
|
9.3 Percentage of participants
|
8.4 Percentage of participants
|
|
Percentage of Participants With Erythema Intensity Score at End of Treatment (LOCF)
Mild
|
51.8 Percentage of participants
|
41.8 Percentage of participants
|
|
Percentage of Participants With Erythema Intensity Score at End of Treatment (LOCF)
Moderate
|
34.2 Percentage of participants
|
43.1 Percentage of participants
|
|
Percentage of Participants With Erythema Intensity Score at End of Treatment (LOCF)
Severe
|
4.8 Percentage of participants
|
6.7 Percentage of participants
|
SECONDARY outcome
Timeframe: Baseline and end of treatment (LOCF), up to 12 weeksPopulation: All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline.
Telangiectasia was rated as: no; mild; moderate; or severe. At the end of study, a participant was considered to have an 'improved' telangiectasia rating if the telangiectasia rating was lower compared to the baseline rating, 'no change' if the rating was identical, and 'worsened' if the rating was higher. The percentage of participants in each category is presented.
Outcome measures
| Measure |
Azelaic Acid Foam, 15% (BAY39-6251)
n=483 Participants
0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
|
Vehicle Foam
n=478 Participants
0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
|
|---|---|---|
|
Grouped Changes From Baseline in Telangiectasia Intensity Score at End of Treatment (LOCF)
No change
|
65.8 Percentage of participants
|
69.7 Percentage of participants
|
|
Grouped Changes From Baseline in Telangiectasia Intensity Score at End of Treatment (LOCF)
Worse
|
6.8 Percentage of participants
|
7.7 Percentage of participants
|
|
Grouped Changes From Baseline in Telangiectasia Intensity Score at End of Treatment (LOCF)
Improved
|
27.3 Percentage of participants
|
22.6 Percentage of participants
|
SECONDARY outcome
Timeframe: At end of treatment (LOCF), up to 12 weeksPopulation: All subjects who were randomized and who were dispensed any study medication. For subjects with missing end of treatment observation the last non-missing observation was carried forward, including baseline.
Facial skin color (as compared with skin outside the treatment area) was rated as: normal; barely visible skin lightening; mild skin lightening; moderate skin lightening; severe skin lightening. The percentage of participants in each category of facial skin color at the end of study is presented.
Outcome measures
| Measure |
Azelaic Acid Foam, 15% (BAY39-6251)
n=483 Participants
0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
|
Vehicle Foam
n=478 Participants
0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
|
|---|---|---|
|
Percentage of Participants With Facial Skin Color Rating at End of Treatment (LOCF)
Normal skin color
|
80.1 Percentage of participants
|
78.7 Percentage of participants
|
|
Percentage of Participants With Facial Skin Color Rating at End of Treatment (LOCF)
Barely visible skin-lightening
|
8.7 Percentage of participants
|
10.5 Percentage of participants
|
|
Percentage of Participants With Facial Skin Color Rating at End of Treatment (LOCF)
Mild skin lightening
|
8.3 Percentage of participants
|
7.7 Percentage of participants
|
|
Percentage of Participants With Facial Skin Color Rating at End of Treatment (LOCF)
Moderate skin lightening
|
2.7 Percentage of participants
|
3.1 Percentage of participants
|
|
Percentage of Participants With Facial Skin Color Rating at End of Treatment (LOCF)
Severe skin lightening
|
0.2 Percentage of participants
|
0 Percentage of participants
|
SECONDARY outcome
Timeframe: At end of treatment, up to 12 weeksPopulation: All subjects who were randomized, were dispensed any study medication and had a non-missing observation at end of treatment.
At the end of treatment, participants assessed the change of papulopustular rosacea from baseline (how it looked, felt, appeared to others) as excellent improvement, good improvement, fair improvement, no improvement, or worse. The number of participants in each category of this assessment is presented.
Outcome measures
| Measure |
Azelaic Acid Foam, 15% (BAY39-6251)
n=435 Participants
0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
|
Vehicle Foam
n=432 Participants
0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
|
|---|---|---|
|
Participants' Global Assessment of Treatment Response at End of Treatment
Excellent improvement
|
75 Participants
|
42 Participants
|
|
Participants' Global Assessment of Treatment Response at End of Treatment
Good improvement
|
174 Participants
|
151 Participants
|
|
Participants' Global Assessment of Treatment Response at End of Treatment
Fair improvement
|
121 Participants
|
128 Participants
|
|
Participants' Global Assessment of Treatment Response at End of Treatment
No improvement
|
57 Participants
|
84 Participants
|
|
Participants' Global Assessment of Treatment Response at End of Treatment
Worse
|
8 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: At end of treatment, up to 12 weeksPopulation: All subjects who were randomized, were dispensed any study medication and had a non-missing observation at end of treatment.
At the end of treatment, participants provided their opinion on local tolerability of the investigational product as excellent, good, acceptable despite minor irritation, less acceptable due to continuous irritation, non-acceptable, or no opinion. The number of participants in each category of this assessment is presented.
Outcome measures
| Measure |
Azelaic Acid Foam, 15% (BAY39-6251)
n=435 Participants
0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
|
Vehicle Foam
n=432 Participants
0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
|
|---|---|---|
|
Participants' Global Assessment of Tolerability at End of Treatment
Excellent
|
167 Participants
|
165 Participants
|
|
Participants' Global Assessment of Tolerability at End of Treatment
Good
|
128 Participants
|
173 Participants
|
|
Participants' Global Assessment of Tolerability at End of Treatment
Acceptable despite minor irritation
|
112 Participants
|
49 Participants
|
|
Participants' Global Assessment of Tolerability at End of Treatment
Less acceptable due to continuous irritation
|
15 Participants
|
27 Participants
|
|
Participants' Global Assessment of Tolerability at End of Treatment
Not acceptable
|
6 Participants
|
7 Participants
|
|
Participants' Global Assessment of Tolerability at End of Treatment
No opinion
|
7 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: At end of treatment, up to 12 weeksPopulation: All subjects who were randomized, were dispensed any study medication and had a non-missing observation at end of treatment.
At the end of treatment, participants provided their opinion on cosmetic acceptability of the investigational product as very good, good, satisfactory, poor, or no opinion. The number of participants in each category of this assessment is presented.
Outcome measures
| Measure |
Azelaic Acid Foam, 15% (BAY39-6251)
n=435 Participants
0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
|
Vehicle Foam
n=432 Participants
0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
|
|---|---|---|
|
Participants' Opinion on Cosmetic Acceptability at End of Treatment
Very good
|
176 Participants
|
124 Participants
|
|
Participants' Opinion on Cosmetic Acceptability at End of Treatment
Good
|
112 Participants
|
142 Participants
|
|
Participants' Opinion on Cosmetic Acceptability at End of Treatment
Satisfactory
|
95 Participants
|
99 Participants
|
|
Participants' Opinion on Cosmetic Acceptability at End of Treatment
Poor
|
36 Participants
|
46 Participants
|
|
Participants' Opinion on Cosmetic Acceptability at End of Treatment
No opinion
|
16 Participants
|
21 Participants
|
SECONDARY outcome
Timeframe: At end of treatment, up to 12 weeksPopulation: All subjects who were randomized, were dispensed any study medication and had a non-missing observation at end of treatment.
At the end of treatment, participants provided their opinion on the practicability of the use of the investigational product in facial areas next to the hairline as very good, good, satisfactory, poor, or no opinion. The number of participants in each category of this assessment is presented.
Outcome measures
| Measure |
Azelaic Acid Foam, 15% (BAY39-6251)
n=435 Participants
0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
|
Vehicle Foam
n=432 Participants
0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
|
|---|---|---|
|
Participants' Opinion on Practicability of Product Use in Facial Areas Next to the Hairline at End of Treatment
Satisfactory
|
67 Participants
|
75 Participants
|
|
Participants' Opinion on Practicability of Product Use in Facial Areas Next to the Hairline at End of Treatment
No opinion
|
25 Participants
|
24 Participants
|
|
Participants' Opinion on Practicability of Product Use in Facial Areas Next to the Hairline at End of Treatment
Very good
|
186 Participants
|
155 Participants
|
|
Participants' Opinion on Practicability of Product Use in Facial Areas Next to the Hairline at End of Treatment
Good
|
143 Participants
|
151 Participants
|
|
Participants' Opinion on Practicability of Product Use in Facial Areas Next to the Hairline at End of Treatment
Poor
|
14 Participants
|
27 Participants
|
SECONDARY outcome
Timeframe: Baseline and end of treatment, up to 12 weeksPopulation: All subjects who were randomized, were dispensed any study medication and had a non-missing observation at end of treatment.
The Rosacea Quality of Life (RosaQoL) is a questionnaire to evaluate the effect of rosacea on a participant's quality of life. Each of the 21 items in this questionnaire asks about the frequency with which a particular aspect of living with rosacea affects the participant: possible responses for each item are "never" (score=1), "rarely" (score=2), "sometimes" (score=3), "often" (score=4), or "all the time" (score=5). The overall score is the sum of the results from all 21 questions, with possible scores ranging from 21 (best) to 105 (worst); the higher the score, the more quality of life is impaired. The mean (standard deviation) of the change, defined as end of treatment overall score minus baseline overall score, is presented.
Outcome measures
| Measure |
Azelaic Acid Foam, 15% (BAY39-6251)
n=435 Participants
0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
|
Vehicle Foam
n=432 Participants
0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Rosacea Quality of Life (RosaQoL) Questionnaire at End of Treatment - Overall Quality of Life Score
|
-6.8 Scores on a scale
Standard Deviation 12.6
|
-6.4 Scores on a scale
Standard Deviation 12.1
|
SECONDARY outcome
Timeframe: Baseline and end of treatment, up to 12 weeksPopulation: All subjects who were randomized, were dispensed any study medication and had a non-missing observation at end of treatment.
The Dermatology Life Quality Index (DLQI) is a questionnaire consisting of a set of 10 questions that evaluate the degree to which the participant's skin has affected certain behaviors and quality of life over the past week. Possible responses to each question are: "very much" (question 7: "yes") (score=3), "a lot" (score=2), "a little" (score=1), or "not at all"/"not relevant" (score=0). The DLQI overall score is the sum of the results from all 10 questions, with possible scores ranging from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired. The number of participants with score changes (end of treatment - baseline) in DLQI overall score from baseline to end of treatment \<=-5 and \>-5 are presented.
Outcome measures
| Measure |
Azelaic Acid Foam, 15% (BAY39-6251)
n=435 Participants
0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
|
Vehicle Foam
n=431 Participants
0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
|
|---|---|---|
|
Number of Participants With Change From Baseline in Dermatology Life Quality Index (DLQI) Questionnaire at End of Treatment - Overall Score
Score change <=-5
|
107 Participants
|
82 Participants
|
|
Number of Participants With Change From Baseline in Dermatology Life Quality Index (DLQI) Questionnaire at End of Treatment - Overall Score
Score change >-5
|
328 Participants
|
349 Participants
|
SECONDARY outcome
Timeframe: Baseline and end of treatment, up to 12 weeksPopulation: All subjects who were randomized, were dispensed any study medication and had a non-missing observation at end of treatment.
The EuroQol Group Questionnaire-Visual Analogue Scale (EQ-VAS) is a standardized instrument for use as a measure of health outcome. The EQ-VAS asks for a judgment of the overall health status assessed by the participant her/himself. The 20-cm visual analog scale (VAS) has endpoints labeled "best imaginable health state" and "worst imaginable health state" that are anchored at 100 and 0, respectively. Respondents are asked to indicate how they rate their own health by drawing a line from an anchor box to that point on the EQ-VAS, which best represents their own health on that day; higher scores indicate a better health state. The median (range) of the change, defined as EQ-VAS at end of treatment minus EQ-VAS at baseline, is presented.
Outcome measures
| Measure |
Azelaic Acid Foam, 15% (BAY39-6251)
n=435 Participants
0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
|
Vehicle Foam
n=431 Participants
0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
|
|---|---|---|
|
Change From Baseline in EuroQol Group Questionnaire-Visual Analogue Scale (EQ-VAS) at End of Treatment
|
0 Scores on a scale
Interval -67.0 to 38.0
|
0 Scores on a scale
Interval -60.0 to 50.0
|
SECONDARY outcome
Timeframe: Baseline and end of treatment, up to 12 weeksPopulation: All subjects who were randomized, were dispensed any study medication and had a non-missing observation at end of treatment.
The EuroQol Group Questionnaire-5 Dimensions-5 Levels (EQ-5D-5L) is a standardized instrument for use as a measure of health outcome. Applicable to a wide range of health conditions and treatments, it provides a simple descriptive profile and a single index value for health status. It is used to assess the level of current health for 5 domains: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. Each dimension is evaluated using 5 levels: "no problems" (level 1), "slight problems" (level 2), "moderate problems" (level 3), "severe problems" (level 4), and "extreme problems" (level 5). A scoring formula developed by EuroQol Group calculates a single index value from the results from all 5 domains along a continuum of 0 (death) to 1 (full health). The median (range) change, defined as the index value at end of treatment minus the index value at baseline, is presented.
Outcome measures
| Measure |
Azelaic Acid Foam, 15% (BAY39-6251)
n=435 Participants
0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
|
Vehicle Foam
n=431 Participants
0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
|
|---|---|---|
|
Change From Baseline in Index Value at End of Treatment
|
0.000 Scores on a scale
Interval -0.41 to 0.339
|
0.000 Scores on a scale
Interval -0.36 to 0.488
|
Adverse Events
Azelaic Acid Foam, 15% (BAY39-6251)
Serious events: 3 serious events
Other events: 148 other events
Deaths: 0 deaths
Vehicle Foam
Serious events: 4 serious events
Other events: 117 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Azelaic Acid Foam, 15% (BAY39-6251)
n=483 participants at risk
0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
|
Vehicle Foam
n=478 participants at risk
0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
|
|---|---|---|
|
Cardiac disorders
Cardiac failure congestive
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
General disorders
Accidental death
|
0.00%
0/483 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
Hepatobiliary disorders
Hepatotoxicity
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Infections and infestations
Gastroenteritis viral
|
0.00%
0/483 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/483 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
Vascular disorders
Deep vein thrombosis
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Vascular disorders
Haemorrhage
|
0.00%
0/483 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
Other adverse events
| Measure |
Azelaic Acid Foam, 15% (BAY39-6251)
n=483 participants at risk
0.5 g azelaic acid (AzA) foam, 15% applied twice daily (BID) topical and nonocclusive on facial skin for 12 weeks.
|
Vehicle Foam
n=478 participants at risk
0.5 g vehicle foam applied twice daily topical and nonocclusive on facial skin for 12 weeks.
|
|---|---|---|
|
Blood and lymphatic system disorders
Lymph node pain
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Cardiac disorders
Tachycardia
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Ear and labyrinth disorders
Vertigo
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Endocrine disorders
Hypothyroidism
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Eye disorders
Conjunctival hyperaemia
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Eye disorders
Conjunctivitis
|
0.41%
2/483 • Number of events 2 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
Eye disorders
Dry eye
|
0.00%
0/483 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
Eye disorders
Eye swelling
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
Eye disorders
Eyelid bleeding
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Eye disorders
Eyelids pruritus
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/483 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
Gastrointestinal disorders
Chapped lips
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/483 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
Gastrointestinal disorders
Gastrooesophageal reflux disease
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/483 • From start of treatment until end of study.
|
0.63%
3/478 • Number of events 3 • From start of treatment until end of study.
|
|
General disorders
Application site acne
|
0.00%
0/483 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
General disorders
Application site dermatitis
|
0.00%
0/483 • From start of treatment until end of study.
|
0.42%
2/478 • Number of events 2 • From start of treatment until end of study.
|
|
General disorders
Application site dryness
|
1.0%
5/483 • Number of events 5 • From start of treatment until end of study.
|
0.63%
3/478 • Number of events 3 • From start of treatment until end of study.
|
|
General disorders
Application site erosion
|
0.00%
0/483 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 4 • From start of treatment until end of study.
|
|
General disorders
Application site erythema
|
0.83%
4/483 • Number of events 5 • From start of treatment until end of study.
|
0.84%
4/478 • Number of events 4 • From start of treatment until end of study.
|
|
General disorders
Application site exfoliation
|
0.41%
2/483 • Number of events 2 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
General disorders
Application site hypersensitivity
|
0.00%
0/483 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
General disorders
Application site inflammation
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
General disorders
Application site irritation
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.63%
3/478 • Number of events 4 • From start of treatment until end of study.
|
|
General disorders
Application site pain
|
3.5%
17/483 • Number of events 23 • From start of treatment until end of study.
|
1.3%
6/478 • Number of events 6 • From start of treatment until end of study.
|
|
General disorders
Application site paraesthesia
|
0.62%
3/483 • Number of events 3 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
General disorders
Application site pruritus
|
1.4%
7/483 • Number of events 7 • From start of treatment until end of study.
|
0.42%
2/478 • Number of events 2 • From start of treatment until end of study.
|
|
General disorders
Application site reaction
|
0.62%
3/483 • Number of events 3 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
General disorders
Application site scab
|
0.00%
0/483 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 2 • From start of treatment until end of study.
|
|
General disorders
Application site warmth
|
0.00%
0/483 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
General disorders
Cyst
|
0.00%
0/483 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
General disorders
Fatigue
|
0.41%
2/483 • Number of events 2 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
General disorders
Influenza like illness
|
0.00%
0/483 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
General disorders
Pain
|
0.00%
0/483 • From start of treatment until end of study.
|
0.63%
3/478 • Number of events 3 • From start of treatment until end of study.
|
|
General disorders
Pyrexia
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/483 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
Immune system disorders
Allergy to arthropod bite
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Immune system disorders
Drug hypersensitivity
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Immune system disorders
Mycotic allergy
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Immune system disorders
Seasonal allergy
|
0.62%
3/483 • Number of events 3 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Infections and infestations
Acute sinusitis
|
0.00%
0/483 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
Infections and infestations
Bronchitis
|
0.62%
3/483 • Number of events 3 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Infections and infestations
Candida infection
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Infections and infestations
Cystitis
|
0.41%
2/483 • Number of events 3 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
Infections and infestations
Ear infection
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Infections and infestations
Folliculitis
|
0.00%
0/483 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
Infections and infestations
Fungal infection
|
0.00%
0/483 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
Infections and infestations
Gastroenteritis viral
|
0.41%
2/483 • Number of events 3 • From start of treatment until end of study.
|
0.42%
2/478 • Number of events 2 • From start of treatment until end of study.
|
|
Infections and infestations
Genital herpes
|
0.00%
0/483 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
Infections and infestations
Herpes zoster
|
0.00%
0/483 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
Infections and infestations
Influenza
|
1.0%
5/483 • Number of events 5 • From start of treatment until end of study.
|
0.63%
3/478 • Number of events 3 • From start of treatment until end of study.
|
|
Infections and infestations
Kidney infection
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Infections and infestations
Laryngitis
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
Infections and infestations
Lower respiratory tract infection
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Infections and infestations
Nasopharyngitis
|
3.9%
19/483 • Number of events 21 • From start of treatment until end of study.
|
3.8%
18/478 • Number of events 19 • From start of treatment until end of study.
|
|
Infections and infestations
Oral herpes
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Infections and infestations
Otitis media
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
Infections and infestations
Periodontitis
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/483 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
Infections and infestations
Pharyngitis streptococcal
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.42%
2/478 • Number of events 2 • From start of treatment until end of study.
|
|
Infections and infestations
Pneumonia
|
0.41%
2/483 • Number of events 2 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
Infections and infestations
Rhinitis
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
Infections and infestations
Sinusitis
|
0.62%
3/483 • Number of events 3 • From start of treatment until end of study.
|
0.63%
3/478 • Number of events 3 • From start of treatment until end of study.
|
|
Infections and infestations
Tooth infection
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Infections and infestations
Upper respiratory tract infection
|
2.1%
10/483 • Number of events 10 • From start of treatment until end of study.
|
1.3%
6/478 • Number of events 6 • From start of treatment until end of study.
|
|
Infections and infestations
Urinary tract infection
|
0.83%
4/483 • Number of events 4 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
Infections and infestations
Viral infection
|
0.41%
2/483 • Number of events 2 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Injury, poisoning and procedural complications
Animal bite
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
Injury, poisoning and procedural complications
Excoriation
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/483 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
Injury, poisoning and procedural complications
Hand fracture
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Injury, poisoning and procedural complications
Laceration
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Injury, poisoning and procedural complications
Ligament rupture
|
0.00%
0/483 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
0.41%
2/483 • Number of events 2 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
Injury, poisoning and procedural complications
Limb injury
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Injury, poisoning and procedural complications
Muscle strain
|
0.00%
0/483 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
Injury, poisoning and procedural complications
Patella fracture
|
0.00%
0/483 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
Injury, poisoning and procedural complications
Periorbital haematoma
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Injury, poisoning and procedural complications
Rib fracture
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Injury, poisoning and procedural complications
Subcutaneous haematoma
|
0.00%
0/483 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
Injury, poisoning and procedural complications
Sunburn
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Injury, poisoning and procedural complications
Thermal burn
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Investigations
Biopsy lip
|
0.00%
0/483 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
Investigations
Biopsy skin
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/483 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
Metabolism and nutrition disorders
Hypercholesterolaemia
|
0.00%
0/483 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
Metabolism and nutrition disorders
Polydipsia
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Metabolism and nutrition disorders
Vitamin D deficiency
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.62%
3/483 • Number of events 3 • From start of treatment until end of study.
|
0.42%
2/478 • Number of events 3 • From start of treatment until end of study.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.62%
3/483 • Number of events 3 • From start of treatment until end of study.
|
0.42%
2/478 • Number of events 2 • From start of treatment until end of study.
|
|
Musculoskeletal and connective tissue disorders
Intervertebral disc protrusion
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/483 • From start of treatment until end of study.
|
0.63%
3/478 • Number of events 3 • From start of treatment until end of study.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.00%
0/483 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
0.00%
0/483 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Basal cell carcinoma
|
0.41%
2/483 • Number of events 2 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Dysplastic naevus
|
0.41%
2/483 • Number of events 3 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Melanocytic naevus
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Neuroendocrine carcinoma
|
0.00%
0/483 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Prostate cancer recurrent
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Pyogenic granuloma
|
0.00%
0/483 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/483 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Squamous cell carcinoma of skin
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Nervous system disorders
Dizziness
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
Nervous system disorders
Dysgeusia
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Nervous system disorders
Headache
|
4.3%
21/483 • Number of events 25 • From start of treatment until end of study.
|
2.3%
11/478 • Number of events 13 • From start of treatment until end of study.
|
|
Nervous system disorders
Migraine
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
Nervous system disorders
Presyncope
|
0.00%
0/483 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
Pregnancy, puerperium and perinatal conditions
Unintended pregnancy
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Psychiatric disorders
Abnormal dreams
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Psychiatric disorders
Affective disorder
|
0.00%
0/483 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
Psychiatric disorders
Depression
|
0.00%
0/483 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
Psychiatric disorders
Major depression
|
0.00%
0/483 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Renal and urinary disorders
Pollakiuria
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Renal and urinary disorders
Renal cyst
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Reproductive system and breast disorders
Dysmenorrhoea
|
0.41%
2/483 • Number of events 2 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic sinusitis
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.41%
2/483 • Number of events 2 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
0.41%
2/483 • Number of events 2 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Respiratory, thoracic and mediastinal disorders
Nasal dryness
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.84%
4/478 • Number of events 4 • From start of treatment until end of study.
|
|
Respiratory, thoracic and mediastinal disorders
Rhinorrhoea
|
0.00%
0/483 • From start of treatment until end of study.
|
0.42%
2/478 • Number of events 2 • From start of treatment until end of study.
|
|
Respiratory, thoracic and mediastinal disorders
Sinus congestion
|
0.41%
2/483 • Number of events 2 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract congestion
|
0.00%
0/483 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
Skin and subcutaneous tissue disorders
Actinic keratosis
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.63%
3/478 • Number of events 7 • From start of treatment until end of study.
|
|
Skin and subcutaneous tissue disorders
Dermal cyst
|
0.00%
0/483 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis allergic
|
0.00%
0/483 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 2 • From start of treatment until end of study.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.62%
3/483 • Number of events 3 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
0.00%
0/483 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
Skin and subcutaneous tissue disorders
Hand dermatitis
|
0.00%
0/483 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
Skin and subcutaneous tissue disorders
Keloid scar
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Skin and subcutaneous tissue disorders
Morbihan disease
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
0.00%
0/483 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
Skin and subcutaneous tissue disorders
Onychoclasis
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.62%
3/483 • Number of events 3 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Skin and subcutaneous tissue disorders
Rosacea
|
0.00%
0/483 • From start of treatment until end of study.
|
0.42%
2/478 • Number of events 2 • From start of treatment until end of study.
|
|
Skin and subcutaneous tissue disorders
Skin burning sensation
|
0.83%
4/483 • Number of events 4 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
0.00%
0/483 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 3 • From start of treatment until end of study.
|
|
Skin and subcutaneous tissue disorders
Skin lesion
|
0.00%
0/483 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Surgical and medical procedures
Artificial crown procedure
|
0.00%
0/483 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
Surgical and medical procedures
Shoulder operation
|
0.00%
0/483 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
|
Surgical and medical procedures
Skin neoplasm excision
|
0.21%
1/483 • Number of events 1 • From start of treatment until end of study.
|
0.00%
0/478 • From start of treatment until end of study.
|
|
Vascular disorders
Hypotension
|
0.00%
0/483 • From start of treatment until end of study.
|
0.21%
1/478 • Number of events 1 • From start of treatment until end of study.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The PI may publish study results of their own patients only after review/comment by the sponsor. At least 60 days prior to submitting a manuscript to a publisher, a copy of the manuscript will be provided to the sponsor for review. No publication of confidential information shall be made without the sponsor's prior written consent. The PI agrees to delete any confidential information which would prejudice the securing of adequate intellectual property protection from the proposed publication.
- Publication restrictions are in place
Restriction type: OTHER