A Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel in Subjects With Acne Vulgaris

Study Overview
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Brief Summary
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This is a multi-center, randomized, double-blind, parallel group study with 12 weeks of treatment of acne vulgaris. Efficacy and safety evaluations will be performed at Screening (safety only), Baseline and Weeks 1, 2, 4, 8 and 12. All Investigator's Global Assessment evaluators and lesion counters must be trained and approved by Galderma. The evaluator of a subject should remain the same during the study. The primary objective is to demonstrate the superiority in efficacy and assess safety of Adapalene/Benzoyl Peroxide Topical Gel (Adapalene/Benzoyl Peroxide Gel) versus Adapalene Topical Gel, 0.1% (Adapalene Monad); Benzoyl Peroxide Topical Gel, 2.5% (Benzoyl Peroxide Monad) and Topical Gel Vehicle (Gel Vehicle) in the treatment of acne vulgaris for up to 12 weeks.

Official Title
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A Multi-Center, Randomized, Double-Blind, Parallel-Group Study to Demonstrate the Efficacy and Safety of Adapalene/Benzoyl Peroxide Topical Gel Compared With Adapalene Topical Gel, 0.1%; Benzoyl Peroxide Topical Gel, 2.5% and Topical Gel Vehicle in Subjects With Acne Vulgaris

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: Adapalene/Benzoyl Peroxide
* Drug: Adapalene
* Drug: Benzoyl Peroxide
* Drug: Topical Gel Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: A clinical diagnosis of acne vulgaris with facial involvement. A minimum of 20 but not more than 50 Inflammatory lesions A minimum of 30 but not more than 100 Noninflammatory lesions A score of 3 (Moderate) on the Investigator's Global Assessment Scale. Exclusion Criteria: More than one acne nodule or any acne cyst. Acne conglobata, acne fulminans, secondary acne, or severe acne. Known previous participation in an Adapalene/Benzoyl Peroxide Topical Gel Trial. Underlying diseases that require the use of interfering topical or systemic therapy. Use of prohibited medications prior to the study unless appropriate washout period is documented Use of hormonal contraceptives solely for control of acne

Ages Eligible for Study
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Minimum Age: 12 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/Benzoyl Peroxide Topical Gel | Drug: Adapalene/Benzoyl Peroxide<br>* Topical Gel, One application daily in the evening for 12 weeks<br>|
| Active Comparator: 2<br>Adapalene Topical Gel | Drug: Adapalene<br>* Topical Gel,One application daily in the evening for 12 weeks<br>|
| Active Comparator: 3<br>Benzoyl Peroxide Topical Gel | Drug: Benzoyl Peroxide<br>* Topical Gel, one application daily in the evening for 12 weeks<br>|
| Placebo Comparator: 4<br>Topical Gel Vehicle | Drug: Topical Gel Vehicle<br>* Topical Gel Vehicle,one application daily 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 |
| --- | --- | --- |
| Success Rate on the Investigator's Global Assessment | Percentage of subjects rated Clear and Almost Clear on 5-point scale (0=clear; 4=severe) | at week 12 | 
| Changes in Inflammatory Lesion Counts | Changes in Inflammatory Lesion Counts equals Week 12 Inflammatory Lesion Counts minus Baseline Inflammatory Lesion Counts | from Baseline to week 12 | 
| Changes in Noninflammatory Lesion Counts | Change in Noninflammatory Lesion Counts equals Week 12 Noninflammatory Lesion Count minus Baseline Noninflammatory Lesion Count | from Baseline to week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Inflammatory Lesion Counts | Percent Changes in Inflammatory Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100 | at week 12 | 
| Percent Change in Noniflammatory Lesion Counts | Percent Changes in Noninflammatory Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100 | at week 12 | 
| Percent Change in Total Lesion Counts | Percent Changes in Total Lesion Counts equals (Week 12 count minus Baseline count) divided by Baseline count multiplied by 100 | at week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acne vulgaris, Adapalene, Benzoyl Peroxide