Clinical Study Between Two 1% Clindamycin/5% Benzoyl Peroxide Topical Gel Formulations

Not Applicable

Completed

• Conditions: Acne Vulgaris
• Interventions: Drug: 1% Clindamycin/5% Benzoyl Peroxide Topical Gel; Drug: Placebo

• Registration Number: NCT01044264
• Lead Sponsor: Padagis LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-12
• Primary Completion: 2008-09
• Study Completion: 2008-09
• Study First Submitted: 2010-01-04
• Study First Submitted QC: 2010-01-05
• Study First Posted: 2010-01-07
• Disposition First Submitted: 2012-03-15
• Disposition First Submitted QC: 2012-03-15
• Disposition First Posted: 2012-03-19
• Results First Submitted: 2012-09-14
• Results First Submitted QC: 2012-11-19
• Results First Posted: 2012-12-17
• Status Verified: 2023-07
• Last Update Submitted: 2023-07-07
• Last Update Posted: 2023-07-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 602

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1% Clindamycin/5% Benzoyl Peroxide Topical Gel	1% Clindamycin/5% Benzoyl Peroxide Topical Gel	Test product
DUAC® 1% Clindamycin/5% Benzoyl Peroxide Topical Gel	1% Clindamycin/5% Benzoyl Peroxide Topical Gel	Reference product
Placebo	Placebo	-

Primary Outcome Measures

Name	Time	Method
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).