Clinical Study Between Two Clindamycin 1%/Benzoyl Peroxide 5% Topical Gels
Phase 3
Completed
- Conditions
- Acne Vulgaris
- Interventions
- Registration Number
- NCT01138514
- Lead Sponsor
- Padagis LLC
- Brief Summary
The purpose of this study is to compare the efficacy and safety profiles of Perrigo Israel Pharmaceuticals, Ltd. Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel and Benzaclin® Topical Gel (Clindamycin- Benzoyl Peroxide Gel).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1555
Inclusion Criteria
- Healthy men or women, 12 to 65 years of age
- Willing to participate and sign provide written consent
- Moderate to severe acne
Exclusion Criteria
- Pregnant or lactating women
- History of unresponsiveness or hypersensitivity to clindamycin, benzoyl peroxide or lincomycin
- Use of systemic, topical or facial products which may interfere with the study
- Participation in any clinical study in the 30 days prior to study entry
- Prolonged exposure to sunlight or excessive exposure to UV lights
- Chronic use of NSAIDS
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Clindamycin 1%/Benzoyl Peroxide 5% Clindamycin 1% / Benzoyl Peroxide 5% (Perrigo) - Reference Product Clindamycin 1% / Benzoyl Peroxide 5% (Benzaclin) - Vehicle Placebo -
- Primary Outcome Measures
Name Time Method Percent Change From Baseline in Non-inflammatory Lesions 10 weeks Percent Change From Baseline in Inflammatory Lesions 10 weeks
- Secondary Outcome Measures
Name Time Method Number of Participant With Clinical Success on the Investigator's Global Assessment (IGA) 10 weeks Clinical success was defined as a score of clear (0) or almost clear (1) at Week 10.