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OpenTrials
Completed

NCT Number: NCT02465632

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

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.

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

12 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Glenmark Investigational Site 10, Belize City, Belize

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel

Drug

BenzaClin® Topical Gel, Clindamycin 1%/Benzoyl Peroxide 5%

Drug

Placebo

Drug

Primary outcomes

  1. 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.

  2. 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.

Sponsors and collaborators

Lead sponsor

Glenmark Pharmaceuticals Ltd. India

Industry

Registry information

Official study title

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.

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 8, 2015
Registry last updated
Jun 28, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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