Trial Outcomes & Findings for Bioequivalence Study of Two Treatments in the Treatment of Acne Vulgaris on the Face (NCT NCT03393494)
NCT ID: NCT03393494
Last Updated: 2021-11-08
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
825 participants
Primary outcome timeframe
Day 1 to week 12
Results posted on
2021-11-08
Participant Flow
Participant milestones
| Measure |
Test Product
Adapalene and Benzoyl Peroxide Topical Gel
|
Reference Product
Epiduo Topical Gel
|
Placebo Product
Placebo gel
|
|---|---|---|---|
|
Overall Study
STARTED
|
329
|
331
|
165
|
|
Overall Study
COMPLETED
|
261
|
256
|
140
|
|
Overall Study
NOT COMPLETED
|
68
|
75
|
25
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Bioequivalence Study of Two Treatments in the Treatment of Acne Vulgaris on the Face
Baseline characteristics by cohort
| Measure |
Perrigo Active
n=329 Participants
Test product
Adapalene and Benzoyl Peroxide Topical Gel: Test product
|
Reference Active
n=331 Participants
RLD product
Epiduo Topical Product: RLD product
|
Perrigo Placebo
n=165 Participants
placebo product
Placebo: Placebo gel
|
Total
n=825 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
160 Participants
n=99 Participants
|
161 Participants
n=107 Participants
|
76 Participants
n=206 Participants
|
397 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
169 Participants
n=99 Participants
|
170 Participants
n=107 Participants
|
89 Participants
n=206 Participants
|
428 Participants
n=7 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Sex: Female, Male
Female
|
117 Participants
n=99 Participants
|
129 Participants
n=107 Participants
|
69 Participants
n=206 Participants
|
315 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
212 Participants
n=99 Participants
|
202 Participants
n=107 Participants
|
96 Participants
n=206 Participants
|
510 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
126 Participants
n=99 Participants
|
120 Participants
n=107 Participants
|
53 Participants
n=206 Participants
|
299 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
203 Participants
n=99 Participants
|
211 Participants
n=107 Participants
|
112 Participants
n=206 Participants
|
526 Participants
n=7 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
4 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
23 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
1 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Black or African American
|
51 Participants
n=99 Participants
|
48 Participants
n=107 Participants
|
30 Participants
n=206 Participants
|
129 Participants
n=7 Participants
|
|
Race (NIH/OMB)
White
|
241 Participants
n=99 Participants
|
256 Participants
n=107 Participants
|
122 Participants
n=206 Participants
|
619 Participants
n=7 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
0 Participants
n=7 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
21 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
9 Participants
n=206 Participants
|
49 Participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Day 1 to week 12Population: Per protocol population
Outcome measures
| Measure |
Perrigo Active
n=202 Participants
Test product
Adapalene and Benzoyl Peroxide Topical Gel: Test product
|
Reference Active
n=218 Participants
RLD product
Epiduo Topical Product: RLD product
|
Perrigo Placebo
n=120 Participants
placebo product
Placebo: Placebo gel
|
|---|---|---|---|
|
Mean Percent Change From Baseline in the Papules and Pustules Lesion Count
|
68.18 percentage of lesion change
Standard Deviation 28.96
|
63.56 percentage of lesion change
Standard Deviation 31.57
|
50.72 percentage of lesion change
Standard Deviation 35.12
|
PRIMARY outcome
Timeframe: Day 1 to week 12Population: Per protocol population
Per protocol population
Outcome measures
| Measure |
Perrigo Active
n=202 Participants
Test product
Adapalene and Benzoyl Peroxide Topical Gel: Test product
|
Reference Active
n=218 Participants
RLD product
Epiduo Topical Product: RLD product
|
Perrigo Placebo
n=120 Participants
placebo product
Placebo: Placebo gel
|
|---|---|---|---|
|
Mean Percent Change From Baseline in the Open and Closed Comedones Lesion Count
|
62.75 percentage of lesion change
Standard Deviation 28.09
|
60.78 percentage of lesion change
Standard Deviation 33.73
|
43.45 percentage of lesion change
Standard Deviation 36.30
|
Adverse Events
Perrigo Active
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Reference Active
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Perrigo Placebo
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Perrigo Active
n=329 participants at risk
Test product
Adapalene and Benzoyl Peroxide Topical Gel: Test product
|
Reference Active
n=331 participants at risk
RLD product
Epiduo Topical Product: RLD product
|
Perrigo Placebo
n=165 participants at risk
placebo product
Placebo: Placebo gel
|
|---|---|---|---|
|
Nervous system disorders
Cervical Radiculopathy
|
0.00%
0/329 • 12 Weeks
|
0.00%
0/331 • 12 Weeks
|
0.61%
1/165 • Number of events 1 • 12 Weeks
|
|
Pregnancy, puerperium and perinatal conditions
Abortion spontaneous
|
0.00%
0/329 • 12 Weeks
|
0.00%
0/331 • 12 Weeks
|
0.61%
1/165 • Number of events 1 • 12 Weeks
|
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