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Completed

NCT Number: NCT02578043

A Study Comparing Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% to Onexton™ Gel in the Treatment of Acne Vulgaris

The objectives of this study are to evaluate the therapeutic equivalence and safety.

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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 1

About this study

The objectives of this study are to evaluate the therapeutic equivalence and safety of the test product Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% to the reference product Onexton™ Gel (Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%) in the treatment of acne vulgaris and to demonstrate the superiority of the efficacy of these test and reference products over the placebo control.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Healthy male or non pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.
  • Must have a minimum ≥ 25 non-inflammatory lesions and ≥ 20 inflammatory lesions and ≤ 2 nodulocystic lesions at baseline on the face.
  • Must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment.

Exclusion criteria

  • Female subjects who are pregnant, nursing or planning to become pregnant during study participation.
  • A history or presence of Crohn's disease, ulcerative colitis, regional enteritis, or antibiotic-associated colitis.
  • A history of hypersensitivity or allergy to clindamycin, benzoyl peroxide and/or any of the study medication ingredients and its excipients.

Treatment and study plan

Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%

Drug

Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% (Taro Pharmaceuticals Inc.)

Other names: Clindamycin, BPO

Onexton™ Gel

Drug

Onexton™ Gel (Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%) (Valeant Pharmaceuticals LLC)

Other names: Clindamycin, BPO

Placebo

Drug

Placebo (vehicle of the test product) (Taro Pharmaceuticals Inc.)

Other names: Vehicle

Primary outcomes

  1. Demonstration of Bioequivalence

    Time frame: Week 12

    Demonstration of Bioequivalence in percent change in inflammatory and non-inflammatory lesion counts

Secondary outcomes

  1. Clinical response of success

    Time frame: Week 12

    The proportion of subjects with a clinical response of success at week 12 defined as an Investigator's Global Assessment score that is at least 2 grades less than the baseline assessment.

Sponsors and collaborators

Lead sponsor

Sun Pharmaceutical Industries, Inc.

Industry

Registry information

Official study title

A Multi Center Double Blind Randomized Placebo Controlled Parallel Group Study Comparing Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% to Onexton™ Gel and Both Active Treatments to a Placebo Control in the Treatment of Acne Vulgaris

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Oct 16, 2015
Registry last updated
May 18, 2018

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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