A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multiple-Site Study to Evaluate the Therapeutic Equivalence of a Generic Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Glenmark Generics, Ltd) to the Marketed Product BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5% (Valeant Pharmaceuticals, US) in the Treatment of Acne Vulgaris.
Overview
- Phase
- Phase 3
- Intervention
- Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel
- Conditions
- Acne Vulgaris
- Sponsor
- Glenmark Pharmaceuticals Ltd. India
- Enrollment
- 1100
- Locations
- 15
- Primary Endpoint
- Mean Percent Change in the Number of Inflamed Lesions (Papules/Pustules)
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
This is a randomized, double-blind, multiple-site, placebo-controlled, parallel-group study, designed to compare the efficacy and safety of generic Clindamycin 1%/ Benzoyl peroxide 5% topical gel (Glenmark Generics, Ltd), and the marketed product BenzaClin® Topical Gel, Clindamycin 1%/ Benzoyl peroxide 5% (Valeant Pharmaceuticals, US) in the treatment of acne vulgaris.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Male or non-pregnant, non-lactating female, ≥12 and ≤40 years of age with a clinical diagnosis of acne vulgaris.
- •Have facial acne with: ≥20 facial inflammatory lesions (papules and pustules) and ≥25 non-inflammatory lesions (open and closed comedones), and ≤2 nodulocystic lesions (nodules and cysts) and have an IGA score of 2, 3 or 4.
Exclusion Criteria
- •Subject has more than 2 facial nodular lesions; any nodules present will be documented but not included in the inflammatory lesion count for analysis.
- •Subject has active cystic acne.
- •Subject has acne conglobata.
- •Subjects with excessive facial hair such as beards, sideburns, moustaches, etc. that would interfere with the diagnosis or assessment of acne.
Arms & Interventions
Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel
apply a thin layer of gel to the face
Intervention: Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel
BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5%
apply a thin layer of the gel to the face
Intervention: BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5%
Placebo topical gel
apply a thin layer of the gel to the face
Intervention: Placebo
Outcomes
Primary Outcomes
Mean Percent Change in the Number of Inflamed Lesions (Papules/Pustules)
Time Frame: Baseline and 10 Weeks
The number of inflammatory lesions (papules and pustules) count between the treatment groups were estimated.
Mean Percent Change in the Number of Non-inflamed Lesions (Open and Closed Comedones)
Time Frame: Baseline and 10 Weeks
The number of non-inflamed lesions (open and closed comedones) count between treatment groups were estimated.