Trial Outcomes & Findings for Clinical Study Between Two 1% Clindamycin/5% Benzoyl Peroxide Topical Gel Formulations (NCT NCT01044264)
NCT ID: NCT01044264
Last Updated: 2023-07-12
Results Overview
The primary endpoint of the study was the mean percent reduction from baseline to week 11 in inflamed lesion count (papules and pustules).
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
602 participants
Primary outcome timeframe
Baseline and week 11
Results posted on
2023-07-12
Participant Flow
FIRST PATIENT ENROLLED: 12/11/2007 LAST PATIENT COMPLETED: 9/18/2008
Participant milestones
| Measure |
1% Clindamycin/5% Benzoyl Peroxide Topical Gel
Test product
1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel
|
DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel
Reference product
1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel
|
Placebo
Placebo : Placebo
|
|---|---|---|---|
|
Overall Study
STARTED
|
200
|
202
|
200
|
|
Overall Study
COMPLETED
|
110
|
108
|
108
|
|
Overall Study
NOT COMPLETED
|
90
|
94
|
92
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Clinical Study Between Two 1% Clindamycin/5% Benzoyl Peroxide Topical Gel Formulations
Baseline characteristics by cohort
| Measure |
1% Clindamycin/5% Benzoyl Peroxide Topical Gel
n=200 Participants
Test product
1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel
|
DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel
n=202 Participants
Reference product
1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel
|
Placebo
n=200 Participants
Placebo : Placebo
|
Total
n=602 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
117 Participants
n=99 Participants
|
113 Participants
n=107 Participants
|
113 Participants
n=206 Participants
|
343 Participants
n=7 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
83 Participants
n=99 Participants
|
89 Participants
n=107 Participants
|
87 Participants
n=206 Participants
|
259 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
|
|
Age, Continuous
|
19.2 years
STANDARD_DEVIATION 7.3 • n=99 Participants
|
19.5 years
STANDARD_DEVIATION 7.1 • n=107 Participants
|
20.1 years
STANDARD_DEVIATION 8.3 • n=206 Participants
|
19.6 years
STANDARD_DEVIATION 7.6 • n=7 Participants
|
|
Sex: Female, Male
Female
|
103 Participants
n=99 Participants
|
101 Participants
n=107 Participants
|
113 Participants
n=206 Participants
|
317 Participants
n=7 Participants
|
|
Sex: Female, Male
Male
|
97 Participants
n=99 Participants
|
101 Participants
n=107 Participants
|
87 Participants
n=206 Participants
|
285 Participants
n=7 Participants
|
|
Region of Enrollment
United States
|
200 participants
n=99 Participants
|
202 participants
n=107 Participants
|
200 participants
n=206 Participants
|
602 participants
n=7 Participants
|
PRIMARY outcome
Timeframe: Baseline and week 11Population: per-protocol population
The primary endpoint of the study was the mean percent reduction from baseline to week 11 in inflamed lesion count (papules and pustules).
Outcome measures
| Measure |
1% Clindamycin/5% Benzoyl Peroxide Topical Gel
n=110 Participants
Test product
1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel
|
DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel
n=108 Participants
Reference product
1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel
|
Placebo
n=185 Participants
Placebo : Placebo
|
|---|---|---|---|
|
Reduction of Inflammatory Lesions
|
64.39 percentage reduction of lesions
|
63.10 percentage reduction of lesions
|
49.89 percentage reduction of lesions
|
Adverse Events
1% Clindamycin/5% Benzoyl Peroxide Topical Gel
Serious events: 1 serious events
Other events: 40 other events
Deaths: 0 deaths
DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel
Serious events: 0 serious events
Other events: 35 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
1% Clindamycin/5% Benzoyl Peroxide Topical Gel
n=200 participants at risk
Test product
1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel
|
DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel
n=202 participants at risk
Reference product
1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel
|
Placebo
n=200 participants at risk
Placebo : Placebo
|
|---|---|---|---|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Kidney Cancer
|
0.50%
1/200 • Number of events 1 • 11 week treatment period
|
0.00%
0/202 • 11 week treatment period
|
0.00%
0/200 • 11 week treatment period
|
|
Renal and urinary disorders
Hematuria
|
0.50%
1/200 • Number of events 1 • 11 week treatment period
|
0.00%
0/202 • 11 week treatment period
|
0.00%
0/200 • 11 week treatment period
|
|
Psychiatric disorders
Mild Bipolar Conduct Disorder
|
0.00%
0/200 • 11 week treatment period
|
0.00%
0/202 • 11 week treatment period
|
0.50%
1/200 • Number of events 1 • 11 week treatment period
|
Other adverse events
| Measure |
1% Clindamycin/5% Benzoyl Peroxide Topical Gel
n=200 participants at risk
Test product
1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel
|
DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel
n=202 participants at risk
Reference product
1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel
|
Placebo
n=200 participants at risk
Placebo : Placebo
|
|---|---|---|---|
|
Skin and subcutaneous tissue disorders
application site dryness
|
12.5%
25/200 • 11 week treatment period
|
10.4%
21/202 • 11 week treatment period
|
10.5%
21/200 • 11 week treatment period
|
|
Nervous system disorders
headache
|
1.5%
3/200 • 11 week treatment period
|
4.0%
8/202 • 11 week treatment period
|
1.5%
3/200 • 11 week treatment period
|
|
Ear and labyrinth disorders
Nasopharyngitis
|
2.0%
4/200 • 11 week treatment period
|
1.5%
3/202 • 11 week treatment period
|
1.0%
2/200 • 11 week treatment period
|
|
Skin and subcutaneous tissue disorders
Application Site Burning
|
2.0%
4/200 • 11 week treatment period
|
0.99%
2/202 • 11 week treatment period
|
0.50%
1/200 • 11 week treatment period
|
|
Infections and infestations
Influenza
|
2.0%
4/200 • 11 week treatment period
|
0.50%
1/202 • 11 week treatment period
|
0.50%
1/200 • 11 week treatment period
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER