Comparison of Four Different Regimens of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in Acne Vulgaris

Study Overview
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Brief Summary
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The purpose of this study is to compare the tolerability of 3 treatment regimens containing Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel with that of Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 weeks in the treatment of acne vulgaris. The efficacy of the four treatment regimens will also be evaluated.

Official Title
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Efficacy and Safety Comparison of Four Different Regimens of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel in the Treatment of Acne Vulgaris

Conditions
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Acne

Intervention / Treatment
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* Drug: Adapalene BPO Gel standard daily overnight application
* Drug: Adapalene-BPO 3-hour daily application before bedtime
* Drug: Adapalene-BPO Gel every other day application
* Drug: Adapalene-BPO Gel standard+Cetaphil® Moisturizing Lotion


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female Subjects of any race, aged 12 to 35 years inclusive Subjects with mild or moderate facial acne vulgaris Subjects with skin phototype I to IV Exclusion Criteria: Subjects with more than 1 nodules or cysts on the face, Subjects with acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.)

Ages Eligible for Study
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Minimum Age: 12 Years
Maximum Age: 35 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: 1<br>Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel 3-hour daily application before bedtime for first 4 weeks and then standard overnight daily application for the following 8 weeks | Drug: Adapalene-BPO 3-hour daily application before bedtime<br>* Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel 3-hour daily application before bedtime for first 4 weeks and then standard overnight daily application for the following 8 weeks<br>* Other names: 3-hour before bedtime;|
| Experimental: 2<br>Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel every other day application for the first 4 weeks and then standard overnight daily application for the following 8 weeks | Drug: Adapalene-BPO Gel every other day application<br>* Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel every other day application for the first 4 weeks and then standard overnight daily application for the following 8 weeks<br>* Other names: every other day;|
| Experimental: 3<br>Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel standard daily overnight application with Cetaphil® Moisturizing Lotion application at wake-up time for the first 4 weeks and then standard daily overnight application for the following 8 weeks | Drug: Adapalene-BPO Gel standard+Cetaphil® Moisturizing Lotion<br>* Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel standard daily overnight application with Cetaphil® Moisturizing Lotion application at wake-up time for the first 4 weeks and then standard daily overnight application for the following 8 weeks<br>* Other names: Adapalene-BPO Gel with Cetaphil® Moisturizing Lotion;|
| Active Comparator: 4<br>Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week | Drug: Adapalene BPO Gel standard daily overnight application<br>* Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel standard daily overnight application for 12 week<br>* Other names: Standard;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Local Tolerability Was Analyzed in Terms of Worst Score Post-Baseline. | Total Sum Score (TSS) is the sum of the 4 local tolerability scores for dryness, erythema, scaling and stinging/burning evaluated at each visit [None=0, Mild=1, Moderate=2 and Severe=3]. In consequence, it ranges from 0 [better outcome] to 12 [worse outcome]and was calculated for each study visit. | Week 4 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acne