Assessment of Subjects' Efficacy and Experiences Using Adapalene BPO Gel in the Treatment of Acne Vulgaris

Study Overview
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Brief Summary
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The purpose of this study is to assess subjects' experiences using Adapalene BPO gel to treat mild to moderate acne vulgaris using efficacy measurements, quality of life instruments, and video diaries.

Official Title
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Assessment of Subjects' Efficacy and Experiences Using Adapalene BPO Gel in the Treatment of Acne Vulgaris

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: Adapalene 0.1% and Benzoyl Peroxide 2.5% gel


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Male or female subjects, aged 16 to 25 years inclusive; Subjects with mild or moderate facial acne (Investigator's Global Assessment (IGA) = 2 or 3; A minimum of 10 inflammatory lesions (papules and pustules) on the face (excluding the nose); Subjects who agree to be photographed at each visit; Subjects who agree to be video recorded by study designated staff members. They should be able to clearly and comfortably communicate their responses to questions and express their thoughts related to their disease and treatment throughout the study Exclusion Criteria: Subjects with nodules, cysts, acne conglobata, acne fulminans, secondary acne (chloracne, drug-induced acne, etc.) or severe acne requiring systemic treatment; Subjects with a wash-out period for topical acne treatment on the face less than 30 days Subjects with a wash-out period for systemic acne treatment less than 30 days with the exception of isotretinoin which requires a washout of 4 months; Subjects who are currently being treated with antibiotics; Subjects who foresee intensive ultraviolet (UV) exposure during the study (mountain sports, UV radiation, sunbathing, tanning beds, etc.); Subjects who refuse photographic and videography procedures and/or refuse to sign a full release for their use in promotional materials

Ages Eligible for Study
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Minimum Age: 16 Years
Maximum Age: 25 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
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Adapalene 0.1% and Benzoyl Peroxide 2.5% gel<br> | Drug: Adapalene 0.1% and Benzoyl Peroxide 2.5% gel<br>* Apply adapalene BPO gel once daily in the evening for 12 weeks<br>* Other names: Epiduo® Gel;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants Who Were a Success (Subject's Global Assessment of 'Clear' or 'Almost Clear') at Week 12 | Number of participants who were a Success (Subject's Global Assessment of 'Clear or 'Almost Clear') at week 12. Subject's Global Assessment is measured on a scale (Clear, Almost Clear, Mild, Moderate, Severe, Very Severe) with Clear being best and Very Severe being worst. | 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent Change From Baseline in Lesion Counts (Inflammatory, Non-inflammatory, and Total) at Week 12. | Mean percent change from baseline in lesions counts (inflammatory, non-inflammatory, and total) at week 12. | Week 12 | 
| Number of Participants With Tolerability Assessments Resulting in an Adverse Event | Number of participants with tolerability assessments resulting in an adverse event. Tolerability assessments include erythema (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe); Scaling (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe); Dryness (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe); Stinging/Burning (0 = None, 1 = Mild, 2 = Moderate, 3 = Severe) with a score of None being best and a score of Severe being worst. | 12 weeks |