Trial Outcomes & Findings for Adapalene BPO Gel Pump, Moisturizer SPF 30 and Foam Wash in Patients With Mild to Moderate Acne Vulgaris (NCT NCT01951417)
NCT ID: NCT01951417
Last Updated: 2022-08-23
Results Overview
The change in total lesion count after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 2 weeks, 4 weeks, and 8 weeks.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
81 participants
Primary outcome timeframe
Baseline, 2, 4, and 8 weeks
Results posted on
2022-08-23
Participant Flow
Participant milestones
| Measure |
Adapalene/BPO Gel/Foam Wash/Moisturizer
Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
Foam Wash: Foam Wash (twice daily)
|
|---|---|
|
Overall Study
STARTED
|
81
|
|
Overall Study
COMPLETED
|
72
|
|
Overall Study
NOT COMPLETED
|
9
|
Reasons for withdrawal
| Measure |
Adapalene/BPO Gel/Foam Wash/Moisturizer
Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
Foam Wash: Foam Wash (twice daily)
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Protocol Violation
|
2
|
|
Overall Study
Lost to Follow-up
|
6
|
Baseline Characteristics
Adapalene BPO Gel Pump, Moisturizer SPF 30 and Foam Wash in Patients With Mild to Moderate Acne Vulgaris
Baseline characteristics by cohort
| Measure |
Adapalene/BPO Gel/Foam Wash/Moisturizer
n=81 Participants
Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
Foam Wash: Foam Wash (twice daily)
|
|---|---|
|
Age, Continuous
|
19.0 years
STANDARD_DEVIATION 7.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
40 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
41 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
24 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
48 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
17 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
64 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Skin Type
Dry
|
5 participants
n=5 Participants
|
|
Skin Type
Normal
|
22 participants
n=5 Participants
|
|
Skin Type
Oily
|
32 participants
n=5 Participants
|
|
Skin Type
Combination
|
22 participants
n=5 Participants
|
|
Fitzpatrick Skin Type
I
|
3 participants
n=5 Participants
|
|
Fitzpatrick Skin Type
II
|
20 participants
n=5 Participants
|
|
Fitzpatrick Skin Type
III
|
16 participants
n=5 Participants
|
|
Fitzpatrick Skin Type
IV
|
19 participants
n=5 Participants
|
|
Fitzpatrick Skin Type
V
|
13 participants
n=5 Participants
|
|
Fitzpatrick Skin Type
VI
|
10 participants
n=5 Participants
|
|
History of Acne
|
4.4 years
STANDARD_DEVIATION 4.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 2, 4, and 8 weeksPopulation: ITT population (all subjects who had at least 1 post-treatment administration evaluation)
The change in total lesion count after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 2 weeks, 4 weeks, and 8 weeks.
Outcome measures
| Measure |
Adapalene/BPO Gel/Foam Wash/Moisturizer
n=77 Participants
Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
Foam Wash: Foam Wash (twice daily)
|
Week 2
Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
* Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
* Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
* Foam Wash: Foam Wash (twice daily)
|
Week 4
Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
* Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
* Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
* Foam Wash: Foam Wash (twice daily)
|
Week 8
Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
* Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
* Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
* Foam Wash: Foam Wash (twice daily)
|
|---|---|---|---|---|
|
Total Lesion Count
Baseline
|
76.7 lesions
Standard Deviation 21.1
|
—
|
—
|
—
|
|
Total Lesion Count
Week 2
|
53.9 lesions
Standard Deviation 25.5
|
—
|
—
|
—
|
|
Total Lesion Count
Week 4
|
50.0 lesions
Standard Deviation 27.8
|
—
|
—
|
—
|
|
Total Lesion Count
Week 8
|
43.7 lesions
Standard Deviation 22.7
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 2, 4, and 8 weeksPopulation: ITT population (all subjects who had at least 1 post-treatment administration evaluation)
The change in inflammatory lesions after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 2 weeks, 4 weeks, and 8 weeks.
Outcome measures
| Measure |
Adapalene/BPO Gel/Foam Wash/Moisturizer
n=77 Participants
Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
Foam Wash: Foam Wash (twice daily)
|
Week 2
Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
* Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
* Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
* Foam Wash: Foam Wash (twice daily)
|
Week 4
Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
* Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
* Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
* Foam Wash: Foam Wash (twice daily)
|
Week 8
Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
* Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
* Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
* Foam Wash: Foam Wash (twice daily)
|
|---|---|---|---|---|
|
Inflammatory Lesions
Baseline
|
27.3 lesions
Standard Deviation 6.4
|
—
|
—
|
—
|
|
Inflammatory Lesions
Week 2
|
17.4 lesions
Standard Deviation 9.0
|
—
|
—
|
—
|
|
Inflammatory Lesions
Week 4
|
15.7 lesions
Standard Deviation 11.3
|
—
|
—
|
—
|
|
Inflammatory Lesions
Week 8
|
14.4 lesions
Standard Deviation 9.5
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 2, 4, and 8 weeksPopulation: ITT population (all subjects who had at least 1 post-treatment administration evaluation)
The change in non-inflammatory lesions after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 2 weeks, 4 weeks, and 8 weeks
Outcome measures
| Measure |
Adapalene/BPO Gel/Foam Wash/Moisturizer
n=77 Participants
Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
Foam Wash: Foam Wash (twice daily)
|
Week 2
Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
* Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
* Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
* Foam Wash: Foam Wash (twice daily)
|
Week 4
Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
* Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
* Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
* Foam Wash: Foam Wash (twice daily)
|
Week 8
Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
* Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
* Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
* Foam Wash: Foam Wash (twice daily)
|
|---|---|---|---|---|
|
Non-inflammatory Lesions
Baseline
|
49.4 lesions
Standard Deviation 18.3
|
—
|
—
|
—
|
|
Non-inflammatory Lesions
Week 2
|
36.4 lesions
Standard Deviation 21.5
|
—
|
—
|
—
|
|
Non-inflammatory Lesions
Week 4
|
34.1 lesions
Standard Deviation 23.4
|
—
|
—
|
—
|
|
Non-inflammatory Lesions
Week 8
|
29.2 lesions
Standard Deviation 18.3
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, 2, 4, and 8 weeksPopulation: ITT population (all subjects who had at least 1 post-treatment administration evaluation)
Describe subject satisfaction after use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks.
Outcome measures
| Measure |
Adapalene/BPO Gel/Foam Wash/Moisturizer
n=77 Participants
Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
Foam Wash: Foam Wash (twice daily)
|
Week 2
Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
* Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
* Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
* Foam Wash: Foam Wash (twice daily)
|
Week 4
Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
* Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
* Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
* Foam Wash: Foam Wash (twice daily)
|
Week 8
Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
* Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
* Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
* Foam Wash: Foam Wash (twice daily)
|
|---|---|---|---|---|
|
Subject Questionnaire
Very satisfied
|
23 participants
|
—
|
—
|
—
|
|
Subject Questionnaire
Satisfied
|
42 participants
|
—
|
—
|
—
|
|
Subject Questionnaire
Undecided
|
5 participants
|
—
|
—
|
—
|
|
Subject Questionnaire
Dissatisfied
|
3 participants
|
—
|
—
|
—
|
|
Subject Questionnaire
Very dissatisfied
|
1 participants
|
—
|
—
|
—
|
|
Subject Questionnaire
Missing
|
3 participants
|
—
|
—
|
—
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 2, 4, and 8 weeksPopulation: As observed population
Cutaneous irritability assessments (stinging/burning, erythema, scaling, dryness) experienced during use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks.
Outcome measures
| Measure |
Adapalene/BPO Gel/Foam Wash/Moisturizer
n=81 Participants
Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
Foam Wash: Foam Wash (twice daily)
|
Week 2
n=76 Participants
Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
* Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
* Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
* Foam Wash: Foam Wash (twice daily)
|
Week 4
n=76 Participants
Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
* Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
* Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
* Foam Wash: Foam Wash (twice daily)
|
Week 8
n=72 Participants
Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
* Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
* Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
* Foam Wash: Foam Wash (twice daily)
|
|---|---|---|---|---|
|
Erythema
None
|
50 participants
|
49 participants
|
45 participants
|
52 participants
|
|
Erythema
Mild
|
28 participants
|
20 participants
|
26 participants
|
18 participants
|
|
Erythema
Moderate
|
3 participants
|
7 participants
|
5 participants
|
2 participants
|
|
Erythema
Severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 2, 4, and 8 weeksPopulation: As observed population
Cutaneous irritability assessments (stinging/burning, erythema, scaling, dryness) experienced during use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks.
Outcome measures
| Measure |
Adapalene/BPO Gel/Foam Wash/Moisturizer
n=81 Participants
Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
Foam Wash: Foam Wash (twice daily)
|
Week 2
n=76 Participants
Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
* Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
* Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
* Foam Wash: Foam Wash (twice daily)
|
Week 4
n=76 Participants
Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
* Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
* Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
* Foam Wash: Foam Wash (twice daily)
|
Week 8
n=72 Participants
Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
* Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
* Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
* Foam Wash: Foam Wash (twice daily)
|
|---|---|---|---|---|
|
Scaling
None
|
73 participants
|
57 participants
|
65 participants
|
63 participants
|
|
Scaling
Mild
|
8 participants
|
15 participants
|
9 participants
|
9 participants
|
|
Scaling
Moderate
|
0 participants
|
4 participants
|
2 participants
|
0 participants
|
|
Scaling
Severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 2, 4, and 8 weeksPopulation: As observed population
Cutaneous irritability assessments (stinging/burning, erythema, scaling, dryness) experienced during use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks.
Outcome measures
| Measure |
Adapalene/BPO Gel/Foam Wash/Moisturizer
n=81 Participants
Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
Foam Wash: Foam Wash (twice daily)
|
Week 2
n=76 Participants
Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
* Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
* Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
* Foam Wash: Foam Wash (twice daily)
|
Week 4
n=76 Participants
Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
* Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
* Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
* Foam Wash: Foam Wash (twice daily)
|
Week 8
n=72 Participants
Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
* Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
* Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
* Foam Wash: Foam Wash (twice daily)
|
|---|---|---|---|---|
|
Dryness
None
|
71 participants
|
45 participants
|
56 participants
|
60 participants
|
|
Dryness
Mild
|
10 participants
|
22 participants
|
19 participants
|
11 participants
|
|
Dryness
Moderate
|
0 participants
|
9 participants
|
1 participants
|
1 participants
|
|
Dryness
Severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: Baseline, 2, 4, and 8 weeksPopulation: As observed population
Cutaneous irritability assessments (stinging/burning, erythema, scaling, dryness) experienced during use of adapalene BPO gel in conjunction with Foam Wash and Moisturizer SPF 30 for 8 weeks.
Outcome measures
| Measure |
Adapalene/BPO Gel/Foam Wash/Moisturizer
n=81 Participants
Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
Foam Wash: Foam Wash (twice daily)
|
Week 2
n=76 Participants
Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
* Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
* Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
* Foam Wash: Foam Wash (twice daily)
|
Week 4
n=76 Participants
Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
* Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
* Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
* Foam Wash: Foam Wash (twice daily)
|
Week 8
n=72 Participants
Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
* Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
* Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
* Foam Wash: Foam Wash (twice daily)
|
|---|---|---|---|---|
|
Stinging/Burning
None
|
80 participants
|
48 participants
|
63 participants
|
62 participants
|
|
Stinging/Burning
Mild
|
1 participants
|
23 participants
|
12 participants
|
10 participants
|
|
Stinging/Burning
Moderate
|
0 participants
|
5 participants
|
1 participants
|
0 participants
|
|
Stinging/Burning
Severe
|
0 participants
|
0 participants
|
0 participants
|
0 participants
|
Adverse Events
Adapalene/BPO Gel/Foam Wash/Moisturizer
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Adapalene/BPO Gel/Foam Wash/Moisturizer
n=81 participants at risk
Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)
Adapalene/BPO Gel: Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)
Moisturizer SPF 30: Moisturizer SPF 30 (once daily)
Foam Wash: Foam Wash (twice daily)
|
|---|---|
|
Skin and subcutaneous tissue disorders
Erythema
|
7.4%
6/81 • Number of events 6 • 8 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
4.9%
4/81 • Number of events 4 • 8 weeks
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
2.5%
2/81 • Number of events 2 • 8 weeks
|
|
Skin and subcutaneous tissue disorders
Skin irritation
|
1.2%
1/81 • Number of events 1 • 8 weeks
|
|
Skin and subcutaneous tissue disorders
Skin burning sensatation
|
1.2%
1/81 • Number of events 1 • 8 weeks
|
|
General disorders
Pain
|
2.5%
2/81 • Number of events 2 • 8 weeks
|
|
Injury, poisoning and procedural complications
Muscle strain
|
1.2%
1/81 • Number of events 1 • 8 weeks
|
|
Injury, poisoning and procedural complications
Accidental exposure to product by child
|
1.2%
1/81 • Number of events 1 • 8 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: LTE60