Clinical Trial Review
March 2011 | Volume 10 | Issue 3 | Original Article | 312 | Copyright © March 2011
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.
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.
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.
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.