Clinical Trial Review

March 2011 | Volume 10 | Issue 3 | Original Article | 312 | Copyright © 2011

Abstract

Clinical Trial Review is a JDD department designed to provide physicians with information on drugs and devices undergoing clinical testing. It is our goal to inform the reader of the status of select drug and device studies relevant to the practice of dermatology before this information is available through standard channels. To participate in or learn more about these and additional trials, visit www.clinicaltrials.gov.

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ACNE

Epiduo Pediatric Acne Study

Sponsored by Galderma. 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 nine to 11 years of age with acne vulgaris.

The primary outcome measures will be to calculate the percentage of subjects rated clear or almost clear with at least two grades reduction from baseline on the IGA and to calculate the change from baseline in total lesion counts.

The secondary outcome measures will be to calculate the percent change in lesion counts and to measure the change in noninflammatory and inflammatory lesion counts.

Inclusion criteria: Clinical diagnosis of acne vulgaris with facial involvement; score of 3 (moderate) on the 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.

IExclusion 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 unwillingness to refrain from such use during the study.

table 2

Comparing OTC Acne Treatment to Prescription Regimen

Sponsored by the Milton S. Hershey Medical Center. Collaborator: L’Oreal USA. The purpose of this study is to assess the safety and efficacy of two acne creams, Effaclar and Benzaclin when used twice daily with a topical retinoid. Effaclar and Benzaclin are FDA approved for the treatment of acne. This study will aim to recognize a treatment combination that is effective in reducing acne vulgaris in adults aged 18-50. This is a multicenter, double-blind clinical trial.

Inclusion criteria: Males and females ages 18-50; mild-to-moderate acne vulgaris with > or equal to 15 inflammatory lesions; > or equal to 20 non-inflammatory lesions; avoidance of excessive sun exposure or tanning beds throughout the study.

Exclusion criteria: Participants who have another skin condition that will interfere with lesion counting or assessments.

table 3

A Study Comparing Aczone Plus Differin Versus Duac Plus Differin in Patients With Severe Facial Acne

Sponsored by Allergan. The purpose of this study is to compare the topical application of Aczone plus Differin versus Duac plus Differin in patients with severe facial acne (facial acne vulgaris).

The primary outcome measure will be to utilize the global acne assessment score (GAAS).

The secondary outcome measures will be to implement the Acne-Specific Quality of Life (Acne-QoL) Questionnaire and to calculate the overall disease severity.

Inclusion criteria: Severe facial acne (acne vulgaris).

Exclusion criteria: History of significant anemia or hemolysis; history of enteritis (e.g., regional enteritis, ulcerative colitis, pseudomembranous colitis, antibiotic-associated colitis); history of lupus, rosacea, or seborrheic dermatitis.

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