Adapalene BPO Gel Pump, Moisturizer SPF 30 and Foam Wash in Patients With Mild to Moderate Acne Vulgaris

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

81 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-10-31

Study Completion Date

2014-03-31

Brief Summary

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This is an open-label, multi-center study to be conducted in the United States. The study will examine the change in lesion count in subjects using Epiduo® Gel Pump (once daily) in conjunction with Cetaphil® DermaControl™ Foam Wash (twice daily) and Moisturizer SPF 30 (once daily). Subjects with a clinical diagnosis of mild or moderate acne who are eligible for treatment with Epiduo® in accordance with the currently approved product labeling and who meet other inclusion/exclusion criteria are to be enrolled in the study and receive the study products for 8 weeks. Efficacy and safety assessments include: complete lesion counts, cutaneous irritation assessment, end of study treatment questionnaire, photographic evaluation for oiliness, skin tone, and P Acnes, hydration assessment, barrier function assessment, treatment compliance, and adverse event assessment.

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Detailed Description

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Conditions

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Acne

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Adapalene/BPO Gel/Foam Wash/Moisturizer

Adapalene BPO Gel Pump (once daily) in conjunction with a Foam Wash (twice daily) and Moisturizer SPF 30 (once daily)

Group Type EXPERIMENTAL

Adapalene/BPO Gel

Intervention Type DRUG

Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)

Moisturizer SPF 30

Intervention Type OTHER

Moisturizer SPF 30 (once daily)

Foam Wash

Intervention Type OTHER

Foam Wash (twice daily)

Interventions

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Adapalene/BPO Gel

Adapalene/Benzoyl Peroxide (BPO) Gel Pump (once daily)

Intervention Type DRUG

Moisturizer SPF 30

Moisturizer SPF 30 (once daily)

Intervention Type OTHER

Foam Wash

Foam Wash (twice daily)

Intervention Type OTHER

Other Intervention Names

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Epiduo® (adapalene and benzoyl peroxide) Gel 0.1%/2.5% Pump Adapalene and benzoyl peroxide (BPO) gel Cetaphil® DermaControl™ Moisturizer SPF 30 Cetaphil® DermaControl™ Foam Wash

Eligibility Criteria

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Inclusion Criteria

\- Men and women of any race, 9 years or older, with a diagnosis of mild to moderate acne, who are eligible for treatment with adapalene BPO gel in accordance with the currently approved product labeling.

Exclusion Criteria

\- Subjects with nodules and cysts, pregnant or breastfeeding, with any systemic or dermatological disorder, or topical condition or facial hair that could interfere with evaluations.

Minimum Eligible Age

9 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No