To Study Generic Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel (Glenmark Generics, Ltd) in the Treatment of Acne Vulgaris.

Overview

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.

Full Title of Study: “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.”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Triple (Participant, Care Provider, Investigator)
  • Study Primary Completion Date: November 2015

Interventions

  • Drug: Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel
  • Drug: BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5%
  • Drug: Placebo

Arms, Groups and Cohorts

  • Experimental: Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel
    • apply a thin layer of gel to the face
  • Active Comparator: BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5%
    • apply a thin layer of the gel to the face
  • Placebo Comparator: Placebo topical gel
    • apply a thin layer of the gel to the face

Clinical Trial Outcome Measures

Primary Measures

  • 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.

Participating in This Clinical Trial

Inclusion Criteria

1. Male or non-pregnant, non-lactating female, ≥12 and ≤40 years of age with a clinical diagnosis of acne vulgaris. 2. 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:

1. Subject has more than 2 facial nodular lesions; any nodules present will be documented but not included in the inflammatory lesion count for analysis. 2. Subject has active cystic acne. 3. Subject has acne conglobata. 4. Subjects with excessive facial hair such as beards, sideburns, moustaches, etc. that would interfere with the diagnosis or assessment of acne.

Gender Eligibility: All

Minimum Age: 12 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Glenmark Pharmaceuticals Ltd. India
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Mahesh V Deshpande, Study Director, Glenmark Pharmaceuticals Ltd

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