Study Comparing Adapalene Gel 0.3% to Differin® and Both to a Placebo Control in Treatment of Acne Vulgaris

Study Overview
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Brief Summary
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The objectives of this study are to evaluate the therapeutic equivalence and safety of Adapalene Gel 0.3% and Differin® (adapalene gel 0.3%).

Detailed Description
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The objectives of this study are to evaluate the therapeutic equivalence and safety of Adapalene Gel 0.3% and Differin® (adapalene gel 0.3%) in the treatment of acne vulgaris and to demonstrate the superiority of the efficacy of the test and reference products over the placebo.

Official Title
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A Multi-Center, Double-Blind, Randomized, Placebo Controlled, Parallel-Group Study Comparing Adapalene Gel 0.3% to Differin® (Adapalene Gel 0.3%) and Both Active 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: Adapalene Gel 0.3%
* Drug: Differin®
* 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 aged 18 years and older must have provided written consent. Subjects aged 12 to 17 years must have provided written assent accompanied by written consent from their legally acceptable representative. All subjects or their legally acceptable representatives must sign Health Insurance Portability and Accountability Act authorization. Must have a minimum of ≥ 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. Have a history of hypersensitivity or allergy to adapalene, retinoids and/or any of the study medication ingredients. Presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris.

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: Adapalene Gel 0.3%<br>Adapalene Gel 0.3% (Taro Pharmaceuticals Inc.) | Drug: Adapalene Gel 0.3%<br>* Adapalene Gel 0.3% applied to the entire face once daily for 84 consecutive days<br>* Other names: Adapalene;|
| Active Comparator: Differin®<br>Differin® (adapalene gel 0.3%) (Galderma Laboratories, LP, US) | Drug: Differin®<br>* Differin® applied to the entire face once daily for 84 consecutive days<br>* Other names: Adapalene;|
| Placebo Comparator: Placebo<br>Placebo (vehicle of the test product) (Taro Pharmaceuticals Inc.) | Drug: Placebo<br>* Placebo (vehicle of the test product) applied to the entire face once daily for 84 consecutive days<br>* Other names: Vehicle;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in inflammatory lesion counts | Percent change from baseline to week 12 in the inflammatory (papules and pustules) lesion counts | Week 12 | 
| Change in non-inflammatory lesion counts | Percent change from baseline to week 12 in the non-inflammatory (open and closed comedones) lesion counts | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical response of success | The proportion of subjects with a clinical response of success at week 12, success defined as an Investigator's Global Assessment score that is at least two grades less than the baseline assessment | Week 12 |