Adapalene-BPO Gel Associated With Doxycycline Hyclate 100 mg in the Treatment of Severe Acne Vulgaris

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 (quoted as BPO) 2.5% Gel associated with Doxycycline Hyclate 100 mg Tablets compared to Adapalene 0.1% /Benzoyl Peroxide 2.5% Vehicle Gel associated with Doxycycline Hyclate 100 mg Tablets, in the treatment of severe acne vulgaris. The safety of the two treatment regimens will also be evaluated.

Detailed Description
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Further to this study, eligible Subjects with at least good Global Assessment of Improvement at Week 12 will be randomized in a maintenance study (SPR.29075)

Official Title
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Efficacy and Safety Comparison of Adapalene 0.1% / Benzoyl Peroxide 2.5% Gel Associated With Doxycycline Hyclate 100 mg Tablets Versus Adapalene 0.1% / Benzoyl Peroxide 2.5% Vehicle Gel Associated With Doxycycline Hyclate 100 mg Tablets in the Treatment of Severe Acne Vulgaris.

Conditions
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Severe Acne Vulgaris

Intervention / Treatment
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* Drug: Adapalene BPO Gel associated with Doxycyline Hyclate
* Drug: Vehicle Gel associated with Doxycycline Hyclate


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 severe facial acne (global severity score of 4) Subjects with a minimum of 20 inflammatory lesions (papules and pustules) on the face, excluding the nose Subjects with a minimum of 30 and a maximum of 120 non-inflammatory lesions (open comedones and closed comedones) on the face, excluding the nose Exclusion Criteria: Subjects with more than 3 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Adapalene-BPO + Doxycyline | Drug: Adapalene BPO Gel associated with Doxycyline Hyclate<br>* Adapalene BPO Gel: Topical to the face, once daily in the evening Doxycycline Hyclate: Oral, 1 tablet once daily in the morning. Both during 12 weeks.<br>* Other names: Adapalene-BPO gel + Doxycycline;|
| Active Comparator: 2<br>Vehicle + Doxycycline | Drug: Vehicle Gel associated with Doxycycline Hyclate<br>* Vehicle Gel: Topical to the face, once daily in the evening; Doxycycline Hyclate: Oral, 1 tablet once daily in the morning. Both during 12 weeks.<br>* Other names: Vehicle gel + Doxycycline;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Total Lesion Counts at Week 12. |  | Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Inflammatory Lesion Counts at Week 12. |  | Week 12 | 
| Percent Change From Baseline in Non-inflammatory Lesion Counts at Week 12 |  | Week 12 | 
| Success Rate on the Investigator's Global Assessment | Percentage of subjects graded Clear or Almost Clear on 6-point IGA scale(0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe and 5=very severe)at week 12 | Week 12 | 
| Percent of Subjects With Adverse Events | Percent of subjects with Adverse Events all along the study (up to 12 weeks follow-up period) | Up to 12 weeks | 

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