Acne Vulgaris
Conditions
Keywords
Acne Vulgaris, bioequivalency, clindamycin, benzoyl peroxide
Brief summary
A randomized, double-blind, multiple-site, placebo-controlled, parallel-group clinical study conducted to evaluate the bioequivalence of two 1% Clindamycin/5% Benzoyl Peroxide Topical Gel formulations.
Interventions
DRUG1% Clindamycin/5% Benzoyl Peroxide Topical Gel
Topical Gel
DRUGPlacebo
Placebo
Sponsors
Padagis LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
12 Years to 40 Years
Healthy volunteers
Yes
Inclusion criteria
* healthy men or women, 12 years of age and older * willing to participate and sign a copy of the informed consent form * moderate to severe facial acne
Exclusion criteria
* history of allergy or hypersensitivity to clindamycin or benzoyl peroxide * pregnant or lactating women * evidence of a clinically significant disorder * receipt of any drugs as part of a research study within 30 days prior to study dosing * use of systemic, topical or facial products which may interfere with study * significant facial hair, tattoos, excessive facial scarring, active facial sunburn, or peeling due to sunburn
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of Inflammatory Lesions | Baseline and week 11 | The primary endpoint of the study was the mean percent reduction from baseline to week 11 in inflamed lesion count (papules and pustules). |
Participant flow
Recruitment details
FIRST PATIENT ENROLLED: 12/11/2007 LAST PATIENT COMPLETED: 9/18/2008
Participants by arm
| Arm | Count |
|---|---|
| 1% Clindamycin/5% Benzoyl Peroxide Topical Gel Test product
1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel | 200 |
| DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel Reference product
1% Clindamycin/5% Benzoyl Peroxide Topical Gel : Topical Gel | 202 |
| Placebo Placebo : Placebo | 200 |
| Total | 602 |
Baseline characteristics
| Characteristic | DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel | Placebo | 1% Clindamycin/5% Benzoyl Peroxide Topical Gel | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 113 Participants | 113 Participants | 117 Participants | 343 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 89 Participants | 87 Participants | 83 Participants | 259 Participants |
| Age, Continuous | 19.5 years STANDARD_DEVIATION 7.1 | 20.1 years STANDARD_DEVIATION 8.3 | 19.2 years STANDARD_DEVIATION 7.3 | 19.6 years STANDARD_DEVIATION 7.6 |
| Region of Enrollment United States | 202 participants | 200 participants | 200 participants | 602 participants |
| Sex: Female, Male Female | 101 Participants | 113 Participants | 103 Participants | 317 Participants |
| Sex: Female, Male Male | 101 Participants | 87 Participants | 97 Participants | 285 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 40 / 200 | 35 / 202 | 28 / 200 |
| serious Total, serious adverse events | 1 / — | 0 / — | 1 / — |
Outcome results
Primary
Reduction of Inflammatory Lesions
The primary endpoint of the study was the mean percent reduction from baseline to week 11 in inflamed lesion count (papules and pustules).
Time frame: Baseline and week 11
Population: per-protocol population
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1% Clindamycin/5% Benzoyl Peroxide Topical Gel | Reduction of Inflammatory Lesions | 64.39 percentage reduction of lesions |
| DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel | Reduction of Inflammatory Lesions | 63.10 percentage reduction of lesions |
| Placebo | Reduction of Inflammatory Lesions | 49.89 percentage reduction of lesions |
90% CI: [92.47, 113.54]Wilcoxon Rank Sum Test