NCT01044264
Completed
Not Applicable
A Randomized, Double-Blind, Multiple-Site, Placebo-Controlled Study Comparing Two 1% Clindamycin/5% Benzoyl Peroxide Topical Gel Formulations in the Treatment of Moderate to Severe Acne Vulgaris
ConditionsAcne Vulgaris
Overview
- Phase
- Not Applicable
- Intervention
- 1% Clindamycin/5% Benzoyl Peroxide Topical Gel
- Conditions
- Acne Vulgaris
- Sponsor
- Padagis LLC
- Enrollment
- 602
- Primary Endpoint
- Reduction of Inflammatory Lesions
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
Eligibility Criteria
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
Arms & Interventions
1% Clindamycin/5% Benzoyl Peroxide Topical Gel
Test product
Intervention: 1% Clindamycin/5% Benzoyl Peroxide Topical Gel
DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel
Reference product
Intervention: 1% Clindamycin/5% Benzoyl Peroxide Topical Gel
Placebo
Intervention: Placebo
Outcomes
Primary Outcomes
Reduction of Inflammatory Lesions
Time Frame: 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).
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