Epiduo Pediatric Acne Study

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the safety and efficacy of Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% administered once daily for up to 12 weeks in subjects 9 to 11 years of age with acne vulgaris.

Official Title
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A Multi-center, Randomized, Vehicle-controlled, Double-blind, Study to Evaluate the Safety and Efficacy of Epiduo® (Adapalene and Benzoyl Peroxide) Gel 0.1%/2.5% Administered Once Daily for the Treatment of Subjects 9 to 11 Years of Age With Acne Vulgaris

Conditions
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Acne

Intervention / Treatment
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* Drug: adapalene/benzoyl peroxide
* Drug: Topical Gel Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of acne vulgaris with facial involvement Score of 3 (moderate) on the Investigator's Global Assessment (IGA) scale A minimum of 20 but not more than 100 total lesions (Noninflammatory and/or Inflammatory) on the face (including the nose) at Baseline Exclusion Criteria: Acne nodule or acne cyst Acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.), or severe acne requiring systemic treatment Underlying diseases and/or dermatologic conditions that require the use of interfering topical or systemic therapy or that might interfere with study assessments Use of prohibited medications prior to the study and/or are unwilling to refrain from such use during the study

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 11 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: adapalene/benzoyl peroxide<br>Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% applied topically once daily for 12 weeks | Drug: adapalene/benzoyl peroxide<br>* daily topical application for 12 weeks<br>* Other names: Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5%;|
| Placebo Comparator: Topical Gel Vehicle<br>Topical Gel Vehicle applied topically once daily for 12 weeks | Drug: Topical Gel Vehicle<br>* daily topical application for 12 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success Rate | Percentage of subjects rated Clear or Almost Clear with at least 2 grades reduction from Baseline on the Investigator's Global Assessment (IGA) | Baseline to Week 12 (Last Observation Carried Forward [LOCF]) | 
| Change From Baseline in Total Lesion Counts |  | Baseline to Week 12 (LOCF) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change in Total Lesion Counts From Baseline |  | Baseline to Week 12 (LOCF) | 
| Change in Inflammatory Lesion Counts From Baseline |  | Baseline to Week 12 (LOCF) |