Adapalene-Benzoy Peroxide (BPO) Gel in the Treatment of Acne Vulgaris as a 6-month Maintenance

Study Overview
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Brief Summary
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The purpose of this study is to demonstrate the efficacy of Adapalene 0.1% /Benzoyl Peroxide 2.5% Gel compared to its Vehicle Gel as an acne maintenance treatment in Subjects previously treated with Adapalene-BPO Gel or Adapalene-BPO Vehicle Gel both associated with Doxycycline Hyclate 100 mg. The safety of the two investigational treatments will also be assessed.

Detailed Description
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This study is a follow-up to RD.03.SPR.29074 - ACCESS I / NCT00688064 - Adapalene-BPO Gel Associated With Doxycycline 100 mg in the Treatment of Severe Acne Vulgaris

Official Title
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Efficacy and Safety Comparison of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Versus Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Vehicle Gel as a 6-month Acne Maintenance Treatment

Conditions
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Acne

Intervention / Treatment
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* Drug: Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel
* Drug: Vehicle Gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subjects who completed the previous study (RD.03.SPR29074 - NCT00688064)and had obtained at least a good Improvement (Grade, 0, 1, 2 or 3) Exclusion Criteria: Female Subjects who are pregnant, nursing or planning a pregnancy during the study Subjects who foresee intensive UV exposure during the study (mountain sports, UV radiation, sunbathing, 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel once daily | Drug: Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel<br>* Topical Gel to the face, once daily in the evening for 24 weeks.<br>* Other names: Adapalene-BPO gel;|
| Placebo Comparator: 2<br>Vehicle Gel once daily | Drug: Vehicle Gel<br>* Topical Gel to the face, once daily in the evening for 24 weeks.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maintenance Success for Total Lesions at Week 24 | Maintenance success for total lesions at Week 24 is defined as the percentage of subjects maintaining at least 50 percent of the improvement obtained with prior combination therapy, in terms of total lesion counts. | Week 24 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Maintenance Success for Inflamatory Lesions at Week 24 | Maintenance success for inflamatory lesions at Week 24 is defined as the percentage of subjects maintaining at least 50 percent of the improvement obtained with prior combination therapy, in terms of inflamatory lesion counts. | Week 24 | 
| Maintenance Success for Non-inflammatory Lesions at Week 24 | Maintenance success for non-inflamatory lesions at Week 24 is defined as the percentage of subjects maintaining at least 50 percent of the improvement obtained with prior combination therapy, in terms of non-inflamatory lesion counts. | Week 24 | 
| Investigator Global Assessment (IGA) Maintenance Success at Week 24 | IGA maintenance success is defined as the percentage of subjects with IGA grade inferior or equal to Baseline IGA grade. IGA grade: 0 Clear:Residual hyperpigmentation & erythema may be present Almost Clear:A few scattered comedones & a few small papules. Mild:Some comedones & some papules and pustules. No nodules present Moderate:Many comedones, papules & pustules. One nodule may be present Severe:Covered with comedones, numerous papules & pustules & few nodules & cysts may be present Very severe:Highly inflammatory acne covering the face; with nodules & cysts present | Baseline, Week 24 | 
| Percent of Subjects With Adverse Events | All participants with events were measured for that particular Outcome Measure and not only the events with a frequency threshold above 2 percent | Up to 24 weeks | 

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