Trial Outcomes & Findings for Comparative Safety and Bioequivalence of Two Treatments in the Treatment of Acne Vulgaris (NCT NCT02525549)
NCT ID: NCT02525549
Last Updated: 2021-11-02
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
903 participants
Primary outcome timeframe
84 days
Results posted on
2021-11-02
Participant Flow
Participant milestones
| Measure |
Test Product
Adapalene and Benzoyl Peroxide Gel
Adapalene and Benzoyl Peroxide Gel
|
Reference Product
Adapalene and Benzoyl Peroxide Gel (Reference)
Adapalene and Benzoyl Peroxide Gel (Reference)
|
Placebo Product
Placebo gel
Placebo gel
|
|---|---|---|---|
|
Overall Study
STARTED
|
365
|
360
|
178
|
|
Overall Study
COMPLETED
|
330
|
307
|
159
|
|
Overall Study
NOT COMPLETED
|
35
|
53
|
19
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparative Safety and Bioequivalence of Two Treatments in the Treatment of Acne Vulgaris
Baseline characteristics by cohort
| Measure |
Test Product
n=365 Participants
Adapalene and Benzoyl Peroxide Gel
Adapalene and Benzoyl Peroxide Gel
|
Reference Product
n=360 Participants
Adapalene and Benzoyl Peroxide Gel (Reference)
Adapalene and Benzoyl Peroxide Gel (Reference)
|
Placebo Product
n=178 Participants
Placebo gel
Placebo gel
|
Total
n=903 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
19.9 years
STANDARD_DEVIATION 6.25 • n=93 Participants
|
20.4 years
STANDARD_DEVIATION 6.96 • n=4 Participants
|
19.5 years
STANDARD_DEVIATION 6.55 • n=27 Participants
|
20.0 years
STANDARD_DEVIATION 6.60 • n=483 Participants
|
|
Sex: Female, Male
Female
|
199 Participants
n=93 Participants
|
213 Participants
n=4 Participants
|
103 Participants
n=27 Participants
|
515 Participants
n=483 Participants
|
|
Sex: Female, Male
Male
|
166 Participants
n=93 Participants
|
147 Participants
n=4 Participants
|
75 Participants
n=27 Participants
|
388 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
70 Participants
n=93 Participants
|
59 Participants
n=4 Participants
|
27 Participants
n=27 Participants
|
156 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
295 Participants
n=93 Participants
|
301 Participants
n=4 Participants
|
151 Participants
n=27 Participants
|
747 Participants
n=483 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=93 Participants
|
4 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Asian
|
17 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
43 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
4 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Black or African American
|
73 Participants
n=93 Participants
|
87 Participants
n=4 Participants
|
34 Participants
n=27 Participants
|
194 Participants
n=483 Participants
|
|
Race (NIH/OMB)
White
|
259 Participants
n=93 Participants
|
245 Participants
n=4 Participants
|
132 Participants
n=27 Participants
|
636 Participants
n=483 Participants
|
|
Race (NIH/OMB)
More than one race
|
6 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
9 Participants
n=483 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
3 Participants
n=27 Participants
|
7 Participants
n=483 Participants
|
PRIMARY outcome
Timeframe: 84 daysPopulation: Per protocol population
Outcome measures
| Measure |
Test Product
n=268 Participants
Adapalene and Benzoyl Peroxide Gel
Adapalene and Benzoyl Peroxide Gel
|
Reference Product
n=247 Participants
Adapalene and Benzoyl Peroxide Gel (Reference)
Adapalene and Benzoyl Peroxide Gel (Reference)
|
Placebo Product
n=134 Participants
Placebo gel
Placebo gel
|
|---|---|---|---|
|
Mean Percent Change From Baseline to Day 84 in Inflammatory (Papules and Pustules) Lesions
|
61.07 percent change of lesion counts
Standard Deviation 36.6
|
65.58 percent change of lesion counts
Standard Deviation 28.42
|
41.63 percent change of lesion counts
Standard Deviation 28.05
|
PRIMARY outcome
Timeframe: 84 daysPopulation: Per protocol population
Outcome measures
| Measure |
Test Product
n=268 Participants
Adapalene and Benzoyl Peroxide Gel
Adapalene and Benzoyl Peroxide Gel
|
Reference Product
n=247 Participants
Adapalene and Benzoyl Peroxide Gel (Reference)
Adapalene and Benzoyl Peroxide Gel (Reference)
|
Placebo Product
n=134 Participants
Placebo gel
Placebo gel
|
|---|---|---|---|
|
Mean Percent Change From Baseline to Day 84 in Non-inflammatory (Open and Closed Comedones) Lesions
|
54.33 percent change of lesion counts
Standard Deviation 32.00
|
55.06 percent change of lesion counts
Standard Deviation 32.62
|
36.40 percent change of lesion counts
Standard Deviation 38.61
|
Adverse Events
Test Product
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Reference Product
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Product
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Test Product
n=365 participants at risk
Adapalene and Benzoyl Peroxide Gel
Adapalene and Benzoyl Peroxide Gel
|
Reference Product
n=360 participants at risk
Adapalene and Benzoyl Peroxide Gel (Reference)
Adapalene and Benzoyl Peroxide Gel (Reference)
|
Placebo Product
n=178 participants at risk
Placebo gel
Placebo gel
|
|---|---|---|---|
|
Nervous system disorders
Convulsion
|
0.00%
0/365 • 84 Days
|
0.28%
1/360 • Number of events 1 • 84 Days
|
0.00%
0/178 • 84 Days
|
|
Infections and infestations
Appendicitis
|
0.00%
0/365 • 84 Days
|
0.28%
1/360 • Number of events 1 • 84 Days
|
0.00%
0/178 • 84 Days
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/365 • 84 Days
|
0.00%
0/360 • 84 Days
|
0.56%
1/178 • Number of events 1 • 84 Days
|
|
Pregnancy, puerperium and perinatal conditions
Abortion Spontaneous
|
0.00%
0/365 • 84 Days
|
0.00%
0/360 • 84 Days
|
0.56%
1/178 • Number of events 1 • 84 Days
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER