Trial Outcomes & Findings for Comparative Safety and Efficacy of Two Treatments in the Treatment of Acne Vulgaris (NCT NCT02515305)
NCT ID: NCT02515305
Last Updated: 2021-11-08
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
890 participants
Primary outcome timeframe
Baseline to Day 84
Results posted on
2021-11-08
Participant Flow
Participant milestones
| Measure |
Test Product
Clindamycin and Benzoyl Peroxide Gel (combination)
|
Reference Product
Clindamycin and Benzoyl Peroxide Gel (Reference) (combination)
|
Placebo Product
Placebo gel (combination)
|
|---|---|---|---|
|
Overall Study
STARTED
|
385
|
378
|
127
|
|
Overall Study
COMPLETED
|
356
|
343
|
113
|
|
Overall Study
NOT COMPLETED
|
29
|
35
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Comparative Safety and Efficacy of Two Treatments in the Treatment of Acne Vulgaris
Baseline characteristics by cohort
| Measure |
Test Product
n=385 Participants
Clindamycin and Benzoyl Peroxide Gel (combination)
|
Reference Product
n=378 Participants
Clindamycin and Benzoyl Peroxide Gel (Reference) (combination)
|
Placebo Product
n=127 Participants
Placebo gel (combination)
|
Total
n=890 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
20.1 years
STANDARD_DEVIATION 5.83 • n=5 Participants
|
20.3 years
STANDARD_DEVIATION 6.07 • n=7 Participants
|
18.9 years
STANDARD_DEVIATION 5.34 • n=5 Participants
|
20.0 years
STANDARD_DEVIATION 5.88 • n=4 Participants
|
|
Sex: Female, Male
Female
|
216 Participants
n=5 Participants
|
213 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
491 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
169 Participants
n=5 Participants
|
165 Participants
n=7 Participants
|
65 Participants
n=5 Participants
|
399 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
230 Participants
n=5 Participants
|
230 Participants
n=7 Participants
|
74 Participants
n=5 Participants
|
534 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
155 Participants
n=5 Participants
|
148 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
356 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
19 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
35 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
66 Participants
n=5 Participants
|
44 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
125 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
226 Participants
n=5 Participants
|
243 Participants
n=7 Participants
|
75 Participants
n=5 Participants
|
544 Participants
n=4 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
73 Participants
n=5 Participants
|
79 Participants
n=7 Participants
|
28 Participants
n=5 Participants
|
180 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to Day 84Population: per protocol population
Outcome measures
| Measure |
Test Product
n=322 Participants
Clindamycin and Benzoyl Peroxide Gel (combination)
|
Reference Product
n=316 Participants
Clindamycin and Benzoyl Peroxide Gel (Reference) (combination)
|
Placebo Product
n=101 Participants
Placebo gel (combination)
|
|---|---|---|---|
|
Mean Percent Change From Baseline in Inflammatory (Papules and Pustules) Lesions
|
71.05 percentage of lesion change
Standard Deviation 29.823
|
72.84 percentage of lesion change
Standard Deviation 26.926
|
51.53 percentage of lesion change
Standard Deviation 28.403
|
PRIMARY outcome
Timeframe: Baseline to Day 84Population: Per protocol population
Outcome measures
| Measure |
Test Product
n=322 Participants
Clindamycin and Benzoyl Peroxide Gel (combination)
|
Reference Product
n=316 Participants
Clindamycin and Benzoyl Peroxide Gel (Reference) (combination)
|
Placebo Product
n=101 Participants
Placebo gel (combination)
|
|---|---|---|---|
|
Mean Percent Change From Baseline in Non-inflammatory (Open and Closed Comedones) Lesions
|
58.99 percentage of lesion change
Standard Deviation 30.032
|
58.93 percentage of lesion change
Standard Deviation 29.046
|
32.25 percentage of lesion change
Standard Deviation 41.322
|
Adverse Events
Test Product
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Reference Product
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Placebo Product
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
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