Anti Propionibacterium(P.) Acnes Activity of Epiduo® Gel Compared to Benzoyl Peroxide (BPO) 2.5% Gel

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the antibacterial activity of Epiduo® Gel (Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel) on P. acnes compared to that of Benzoyl Peroxide 2.5% Gel.

Official Title
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Anti P. Acnes Activity of Epiduo® Gel Compared to Benzoyl Peroxide (BPO) 2.5% Gel in the Treatment of Subjects With Acne Vulgaris

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: Epiduo gel
* Drug: BPO


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects with facial acne, Subjects with high levels of P. acnes counts on the forehead Exclusion Criteria: Female Subjects who are pregnant, nursing or planning a pregnancy during the study, Subjects with acne conglobata, acne fulminans, secondary acne Subjects with known or suspected allergy to one of the test product

Ages Eligible for Study
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Minimum Age: 18 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: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Epiduo gel<br>Dose or Concentration:Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel. Mode and Frequency of Administration:Topical to the face, once daily application in the evening. Duration of Treatment:12 weeks | Drug: Epiduo gel<br>* Once daily application on the face in the evening for 12 weeks<br>* Other names: Epiduo;|
| Active Comparator: BPO gel<br>Dose or Concentration:Adapalene 0% / Benzoyl Peroxide 2.5% Gel. Mode and Frequency of Administration:Topical to the face, once daily application in the evening. Duration of Treatment:12 weeks | Drug: BPO<br>* Once daily application on the face 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 |
| --- | --- | --- |
| Change From Baseline (Log10 Cfu/cm²) in Count of Follicular P. Acnes | Quantitative bacterial examinations were performed on the subjects' face during the study. These samplings were performed using a method to quantify the follicular microbiological flora of the skin (at Baseline and Week 12 visits).This method consists of a technique allowing the extraction of the outermost layer of epidermis from hair follicle on the cheek and to culture the samplings in order to have the number of P. acnes. Outcome measure = Change from baseline (Log10 cfu/cm²) in count of Follicular P. acnes at end of the study. | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change (%) in Inflammatory Lesion Counts | Inflammatory lesions were counted and recorded by the Evaluator (Investigator or designee) at Baseline and at Week 12. Based on these counts at Baseline and Week 12, Percent change (%) from Baseline in inflammatory lesion counts at Week 12 was calculated. | Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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P. acnes, Acne vulgaris