Trial Outcomes & Findings for A Study to Compare Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5% to Acanya® Topical Gel in the Treatment of Acne Vulgaris (NCT NCT01796665)
NCT ID: NCT01796665
Last Updated: 2021-10-22
Results Overview
Per protocol population
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
1180 participants
Primary outcome timeframe
Baseline to week 12
Results posted on
2021-10-22
Participant Flow
Participant milestones
| Measure |
Test Product
Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5% applied to the affected areas of the face once daily.
Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5%
|
Reference Product
Acanya Gel applied to the affected areas of the face once daily.
Acanya Gel
|
Placebo Product
Placebo of the Test product applied to the affected areas of the face once daily.
Placebo of Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5% product
|
|---|---|---|---|
|
Overall Study
STARTED
|
474
|
469
|
237
|
|
Overall Study
COMPLETED
|
416
|
396
|
195
|
|
Overall Study
NOT COMPLETED
|
58
|
73
|
42
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study to Compare Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5% to Acanya® Topical Gel in the Treatment of Acne Vulgaris
Baseline characteristics by cohort
| Measure |
Test Product
n=474 Participants
Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5% applied to the affected areas of the face once daily.
Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5%
|
Reference Product
n=469 Participants
Acanya Gel applied to the affected areas of the face once daily.
Acanya Gel
|
Placebo Product
n=237 Participants
Placebo of the Test product applied to the affected areas of the face once daily.
Placebo of Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5% product
|
Total
n=1180 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
19.7 years
STANDARD_DEVIATION 6.6 • n=5 Participants
|
19.9 years
STANDARD_DEVIATION 6.37 • n=7 Participants
|
19.8 years
STANDARD_DEVIATION 6.23 • n=5 Participants
|
19.8 years
STANDARD_DEVIATION 6.43 • n=4 Participants
|
|
Sex: Female, Male
Female
|
274 Participants
n=5 Participants
|
257 Participants
n=7 Participants
|
130 Participants
n=5 Participants
|
661 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
200 Participants
n=5 Participants
|
212 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
519 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
146 Participants
n=5 Participants
|
147 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
374 Participants
n=4 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
328 Participants
n=5 Participants
|
322 Participants
n=7 Participants
|
156 Participants
n=5 Participants
|
806 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
|
5 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
19 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
4 Participants
n=4 Participants
|
|
Race (NIH/OMB)
Black or African American
|
130 Participants
n=5 Participants
|
108 Participants
n=7 Participants
|
62 Participants
n=5 Participants
|
300 Participants
n=4 Participants
|
|
Race (NIH/OMB)
White
|
289 Participants
n=5 Participants
|
304 Participants
n=7 Participants
|
153 Participants
n=5 Participants
|
746 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
|
44 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
100 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Baseline to week 12Population: Per protocol population
Per protocol population
Outcome measures
| Measure |
Test Product
n=365 Participants
Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5% applied to the affected areas of the face once daily.
Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5%
|
Reference Product
n=339 Participants
Acanya Gel applied to the affected areas of the face once daily.
Acanya Gel
|
Placebo Product
n=163 Participants
Placebo of the Test product applied to the affected areas of the face once daily.
Placebo of Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5% product
|
|---|---|---|---|
|
Mean Percent Change in the Inflammatory (Papules and Pustules) Lesion Count
|
61.70 percent change of lesion counts
Standard Deviation 34.55
|
63.89 percent change of lesion counts
Standard Deviation 39.21
|
42.22 percent change of lesion counts
Standard Deviation 43.03
|
PRIMARY outcome
Timeframe: Baseline to week 12Population: Per protocol population
Outcome measures
| Measure |
Test Product
n=365 Participants
Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5% applied to the affected areas of the face once daily.
Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5%
|
Reference Product
n=339 Participants
Acanya Gel applied to the affected areas of the face once daily.
Acanya Gel
|
Placebo Product
n=163 Participants
Placebo of the Test product applied to the affected areas of the face once daily.
Placebo of Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5% product
|
|---|---|---|---|
|
Mean Percent Change in the Non-inflammatory (Open and Closed Comedones) Lesion Count
|
51.57 percent change of lesion counts
Standard Deviation 31.79
|
51.59 percent change of lesion counts
Standard Deviation 39.85
|
33.33 percent change of lesion counts
Standard Deviation 36.58
|
SECONDARY outcome
Timeframe: Baseline to week 12Population: Per protocol population
Percentage of subjects with a clinical response of "success", defined as an IGA score that is at least 2 grades less than the baseline assessment.
Outcome measures
| Measure |
Test Product
n=365 Participants
Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5% applied to the affected areas of the face once daily.
Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5%
|
Reference Product
n=339 Participants
Acanya Gel applied to the affected areas of the face once daily.
Acanya Gel
|
Placebo Product
n=163 Participants
Placebo of the Test product applied to the affected areas of the face once daily.
Placebo of Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5% product
|
|---|---|---|---|
|
Clinical Success on Investigator's Global Evaluation
|
103 Participants
|
120 Participants
|
23 Participants
|
Adverse Events
Test Product
Serious events: 2 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: 1 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Test Product
n=474 participants at risk
Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5% applied to the affected areas of the face once daily.
Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5%
|
Reference Product
n=469 participants at risk
Acanya Gel applied to the affected areas of the face once daily.
Acanya Gel
|
Placebo Product
n=237 participants at risk
Placebo of the Test product applied to the affected areas of the face once daily.
Placebo of Clindamycin Phosphate and Benzoyl Peroxide Topical Gel 1.2%/2.5% product
|
|---|---|---|---|
|
Nervous system disorders
Skull Fracture, Brain Injury
|
0.21%
1/474 • Number of events 1 • 84 days
|
0.00%
0/469 • 84 days
|
0.00%
0/237 • 84 days
|
|
Psychiatric disorders
Affective Disorder, Attention Deficit/Hyperactivity Disorder, and Oppositional Defiant Disorder
|
0.21%
1/474 • Number of events 1 • 84 days
|
0.00%
0/469 • 84 days
|
0.00%
0/237 • 84 days
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/474 • 84 days
|
0.00%
0/469 • 84 days
|
0.42%
1/237 • 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