Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris

Study Overview
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Brief Summary
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This study is to evaluate the therapeutic equivalence and safety of Taro Product to RLD in the treatment of acne vulgaris.

Detailed Description
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The study objectives are to evaluate the therapeutic equivalence and safety of Taro Product to RLD in the treatment of acne vulgaris and to demonstrate the superiority of the efficacy of the test and reference products over the placebo control.

Official Title
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A Randomized, Double-Blind, Multiple Center Placebo Controlled Study Comparing Taro Product to RLD and Both Treatments to a Placebo Control in the Treatment of Acne Vulgaris.

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: CLPG Topical Gel 1%
* Drug: Clindamycin
* Drug: Placebo


Participation Criteria
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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 Subjects who are 18 years of age or older (up to the age of 40) must have provided IRB approved written informed consent. Subjects 12 to 17 years of age, inclusive, must have provided IRB approved written assent; this written assent must be accompanied by an IRB approved written informed consent from the Subject's legally acceptable representative (i.e., parent or guardian). Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA). Exclusion Criteria: Female Subjects who are pregnant, nursing or planning to become pregnant during study participation. Subjects with a known hypersensitivity to clindamycin or lincomycin and/or any ingredients in the study drugs. Subjects with the presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneiform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CLPG Topical Gel 1%<br>Clindamycin Phosphate Topical Gel 1%, applied to the face twice a day for 84 days. | Drug: CLPG Topical Gel 1%<br>* Clindamycin Phosphate Topical Gel 1% (Taro Pharmaceuticals U.S.A, Inc.)<br>* Other names: Topical Gel 1%;|
| Active Comparator: Clindamycin Phosphate Topical Gel 1%<br>Clindamycin Phosphate Topical Gel 1%, applied to the face twice a day for 84 days. | Drug: Clindamycin<br>* Clindamycin Phosphate topical gel 1%<br>* Other names: Topical Gel 1%;|
| Placebo Comparator: Vehicle of the test product<br>Placebo (vehicle of the test product), applied to the face twice a day for 84 days. | Drug: Placebo<br>* Placebo (vehicle of the test product) (Taro Pharmaceuticals Inc.)<br>* Other names: Vehicle;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Demonstration of Bioequivalence | Demonstration of Bioequivalence in percent change in inflammatory and non-inflammatory lesion counts. | Week 12 |