Clinical Endpoint Bioequivalence Study of Adapalene Gel 0.1%

Study Overview
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Brief Summary
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To evaluate the therapeutic equivalence of topical Adapalene Gel, 0.1 % and Differin®(Adapalene) Gel, 0.1 % in the treatment of acne vulgaris and to demonstrate the superiority of the efficacy of the test and reference products over the placebo.

Detailed Description
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Bio-Equivalence study with a clinical endpoint in the treatment of acne vulgaris comparing adapalene cream, 0.1% test product versus the reference listed drug (RLD) and placebo (vehicle) control, each administered as one application once a day in the evening for 12 weeks

Official Title
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Randomized, Double Blind, Placebo Controlled, Parallel Group Design, Three Arm, Multicentric Study to Evaluate the Efficacy and Safety of Topical Adapalene Gel, 0.1 % in Healthy Males and Nonpregnant Female Subjects With Acne Vulgaris

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: Adapalene 0.1% Gel
* Drug: Differin 0.1% Topical Gel
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or nonpregnant, nonlactating female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris On the face, ≥ 25 non-inflammatory lesions (i.e., open and closed comedones) AND ≥ 20 inflammatory lesions (i.e., papules and pustules) AND ≤ 2 nodulocystic lesions (i.e., nodules and cysts) Investigator's Global Assessment (IGA) of acne severity Grade 2, 3, or 4 Willing to refrain from use of all other topical acne medications or antibiotics during the 12-week treatment period If female of childbearing potential, willing to use an acceptable form of birth control during the study Exclusion Criteria: Pregnant, breast feeding or planning a pregnancy 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, acneform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis) Excessive facial hair (e.g., beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris History of hypersensitivity or allergy to adapalene, retinoids and/or any of the study medication ingredients Use within 6 months prior to baseline or during the study of oral retinoids (e.g., Accutane®) or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed) Use for less than 3 months prior to baseline of estrogens or oral contraceptives; use of such therapy must remain constant throughout the study Use on the face within 1 month prior to baseline or during the study of 1) cryo destruction or chemo destruction, 2) dermabrasion, 3) photodynamic therapy, 4) acne surgery, 5) intralesional steroids, or 6) x-ray therapy Use within 1 month prior to baseline or during the study of 1) systemic steroids, 2) systemic antibiotics, 3) systemic treatment for acne vulgaris (other than oral retinoids, which require a 6-month washout), or 4) systemic anti-inflammatory agents Use within 2 weeks prior to baseline or during the study of 1) topical steroids, 2) topical retinoids, 3) topical acne treatments including over-the-counter preparations, 4) topical anti-inflammatory agents, or 5) topical antibiotics

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: Test Group<br>Adapalene Gel, 0.1%, applied as thin film once daily for 12 weeks | Drug: Adapalene 0.1% Gel<br>* A thin film of the assigned medication to be applied once daily in the evening for 12 weeks<br>|
| Active Comparator: Reference Group<br>Differin® (Adapalene) Gel, 0.1%, applied as thin film once daily for 12 weeks | Drug: Differin 0.1% Topical Gel<br>* A thin film of the assigned medication to be applied once daily in the evening for 12 weeks<br>|
| Placebo Comparator: Placebo Group<br>Placebo Gel, 0.1%, applied as thin film once daily for 12 weeks | Other: Placebo<br>* A thin film of the assigned medication to be applied once daily in the evening for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean percent change from baseline in the inflammatory lesion count. | Mean percent change compared to baseline inflammatory lesion count (papules and pustules) at Day 84 in per protocol population. | 12 weeks | 
| Mean percent change from baseline in the non-inflammatory lesion count. | Mean percent change compared to baseline non-inflammatory lesion count (open and closed comedones) at Day 84 in per protocol population. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of subjects with a clinical response as success or failure | Success will be defined as IGA score that is at least 2 grades less than the baseline assessment. Failure is defined as an IGA score that is the same, higher or one grade lower than the baseline assessment. | 12 weeks | 
| Change in lesion count | Percentage of subjects who achieved at least 50 % reduction in lesion counts (inflammatory, non-inflammatory and total lesion count) | 12 weeks |