Bioequivalence Study of Two Treatments in the Treatment of Acne Vulgaris on the Face

Study Overview
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Brief Summary
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To compare the safety and efficacy of Perrigo's product to an FDA approved product for the treatment of Acne Vulgaris

Official Title
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Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study to Compare Perrigo's Adapalene/BP Gel to Galderma's Epiduo (Adapalene/BP) Gel, and Both Treatments to a Vehicle Control in the Treatment of Acne Vulgaris

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: Adapalene and Benzoyl Peroxide Topical Gel
* Drug: Epiduo Topical Product
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed IRB approved written informed consent/assent 12 to 40 years of age, inclusive. Clinical diagnosis of facial acne vulgaris with an inflammatory lesion (papules and pustules) count of 20-50, inclusive and a non-inflammatory (open and closed comedones) lesion count of 25-100 inclusive and no more than 2 nodulocystic lesions (e.g., nodules and cysts) including those present on the nose. Baseline Investigator's Global Assessment Score of 3 (moderate) or 4 (severe) on a severity scale of 0 to 4. Females of child bearing potential (excluding women who are surgically sterilized (tubal ligation or bilateral oophorectomy or hysterectomy) or post-menopausal for at least 2 years), in addition to having a negative urine pregnancy test at Visit 1/Day1(Baseline), must be willing to use an acceptable form of birth control during the study. Exclusion Criteria: Pregnant, breastfeeding or planning a pregnancy within the period of their study participation period. Presence of more than 2 facial Nodulocystic lesions. Presence of any other facial skin condition that, in the Investigator's opinion, might interfere with acne vulgaris diagnosis and/or evaluations Any uncontrolled, chronic or serious disease or medical condition that would prevent participation in a clinical trial, or, in judgment of the investigator, would put the subject at undue risk or might confound the study assessments Excessive facial hair that would interfere with the diagnosis or assessment of acne vulgaris. History of unresponsiveness to topical adapalene and/or benzoyl peroxide therapy. Currently using any product containing adapalene and/or benzoyl peroxide and/or belonging to the same family. History of hypersensitivity or allergy to adapalene, benzoyl peroxide, retinoids and/or any ingredient in the study medication. Use of medications known to exacerbate acne Start or change within 3 months (90 days) of Visit 1 and throughout the study Use of medicated make-up throughout the study and significant change in the use of consumer products within 30 days (1 month) of study entry and throughout the study Subject consumes excessive alcohol, abuses drugs, or has a condition that could compromise the subject's ability to comply with study requirements. Subjects who in the opinion of the investigator, are unlikely to be able to follow the restrictions of the protocol and complete the study.

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: Perrigo active<br>Test product | Drug: Adapalene and Benzoyl Peroxide Topical Gel<br>* Test product<br>|
| Active Comparator: Reference active<br>RLD product | Drug: Epiduo Topical Product<br>* RLD product<br>|
| Placebo Comparator: Perrigo placebo<br>placebo product | Drug: Placebo<br>* Placebo gel<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 Papules and Pustules Lesion Count |  | Day 1 to week 12 | 
| Mean Percent Change From Baseline in the Open and Closed Comedones Lesion Count | Per protocol population | Day 1 to week 12 |