Clinical Trial Review

December 2011 | Volume 10 | Issue 12 | Feature | 1486 | 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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ATOPIC DERMATITIS

Comparing Cetaphil Restoraderm System Versus Standard Skin Care in Infants

Sponsored by the Oregon Health and Science University. The goal of this study is to determine what effect Cetaphil® Restoraderm® system has on babies' skin versus Johnson & Johnson baby lotion and skin cleanser in infants at risk for atopic dermatitis.

The primary outcome measure will be incidence of atopic dermatitis. The secondary outcome measures will be effects on infants’ skin barrier, and will include adherence measures, time to disease onset, adverse events, and skin barrier function in a sub-set of subjects.

Inclusion criteria: Infants up to three weeks of age born to mothers aged 18-45 years; infants must have a family history of asthma, eczema, or hayfever in at least one first-degree relative and be in otherwise good overall health.

Exclusion criteria: Preterm birth defined as birth prior to 37 weeks gestation; major congenital anomaly; hydrops fetalis; significant dermatitis at birth not including seborrheic dermatitis on the scalp (”cradle cap”); any immunodeficiency disorder; any severe genetic skin disorder; any other serious condition that would make the use of emollients inadvisable; any other major medical problems that the investigator deems may increase the risk of adverse events with the intervention or in whom assessing the outcomes may be masked by the underlying problem or practically very difficult to assess.

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ATOPIC DERMATITIS

Efficacy of Fluocinonide Cream 0.1% in Reducing Itch in Subjects With Atopic Dermatitis

Sponsored by Wake Forest University in collaboration with Medicis Pharmaceautical Corporation. The purpose of this study is to assess the efficacy and tolerability of short-term treatment with fluocinonide cream 0.1% (Vanos®) in the treatment of atopic dermatitis (AD). The study hypothesis is that subjects will have a reduction in Investigator‘s Global Assessment scores at day 7 and day 14 compared to baseline. Secondary objectives include the use of actigraphy monitoring to determine the ability of the cream to reduce itch, and thus nocturnal scratching, in AD.

The primary outcome measure is change in Investigator‘s Global Assessment of atopic dermatitis. The secondary outcome measures are change in actigraphy movement count per hour, change in Eczema Area and Severity Index score, change in Body Surface Area of atopic dermatitis, change in visual analog scale for itch, subject global assessment of atopic dermatitis, and adherence to fluocinonide cream.

Inclusion criteria: Male or female with mild to severe atopic dermatitis, 12 years of age or older, that agrees to participate and provide written consent; has an Investigator Global Assessment of mild to severe atopic dermatitis (IGA rating of 2 through 4); visual analog scale of itch score at baseline must be greater than or equal to 50 on a 100-point scale; percentage of overall body surface area of involvement (BSA) must be ≥2%; women of childbearing potential will be allowed to participate in the study, and will be required to use at least one form of birth control.

Exclusion criteria: Use within four weeks from baseline of any systemic anti-inflammatory medication which may influence study outcome, such as systemic corticosteroids; application

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