N/A
Completed N=602
Clinical Study Between Two 1% Clindamycin/5% Benzoyl Peroxide Topical Gel Formulations
Source: ClinicalTrials.gov NCT01044264 ↗Enrolled (actual)
602
Serious AEs
—
Results posted
Dec 2012
Primary outcomePrimary: Reduction of Inflammatory Lesions — 64.39; 63.10; 49.89 percentage reduction of lesions
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Reduction of Inflammatory Lesions |
64.39; 63.10; 49.89 | — |
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
Data sourced from ClinicalTrials.gov (NCT01044264). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.