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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

844 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-04-30

Study Completion Date

2015-09-30

Brief Summary

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

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Detailed Description

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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.

Conditions

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Acne Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Clindamycin and BPO Gel 1.2%/3.75%

Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75% applied to the face once daily for 84 days.

Group Type EXPERIMENTAL

Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%

Intervention Type DRUG

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

Onexton™ Gel

Onexton™ Gel (Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%) applied to the face once daily for 84 days.

Group Type ACTIVE_COMPARATOR

Onexton™ Gel

Intervention Type DRUG

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

Placebo

Placebo (vehicle of the test product) applied to the face once daily for 84 days.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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Clindamycin and Benzoyl Peroxide Gel 1.2%/3.75%

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

Intervention Type DRUG

Onexton™ Gel

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Other Intervention Names

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Clindamycin, BPO Clindamycin, BPO Vehicle

Eligibility Criteria

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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.

Minimum Eligible Age

12 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No