Clinical Trial Review
October 2015 | Volume 14 | Issue 10 | Feature | 1173 | Copyright © 2015
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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Efficacy of Fluocinonide Cream 0.1% (Vanos®) in Reducing Itch in Subjects With Atopic Dermatitis
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 hypothesis is that subjects will have a reduction in Investigator's Global Assessment scores at day 7 and day 14 compared with baseline.
Secondary objectives include the use of actigraphy monitoring to determine the ability of Vanos® cream to reduce itch, and thus nocturnal scratching, in AD. The hypothesis is that subjects will have a reduction in nocturnal scratching activity, as measured by actigraphy movement count per hour, at day 7 and day 14 compared with baseline. Other secondary outcome measures include Eczema Area and Severity Index score, Body Surface Area Involvement, Visual Analog Scale for itch, and Subject Global Assessment. The investigators hypothesize that each of these measures will be improved at day 7 and day 14 compared with baseline.
Medication adherence will be determined using objective adherence monitors. The investigators also hypothesize that subjects will have improved adherence to a topical medication for AD, compared with published sources, if they are only required to use the medication for a short and defined duration.
Registry for the Atopic Dermatitis Research Network
People with atopic dermatitis (AD), also known as eczema, experience hot, dry, scaly skin with severe itching. In addition, people with AD are prone to skin infections and inflammation. Little is known about the causes of AD or why people with AD are more prone to infections. The purpose of this multicenter, clinical registry study is to determine genetic markers associated with susceptibility of AD patients to infections and also to serve as a potential participant database for future studies.
Participants include those with atopic dermatitis with previous or current eczema herpeticum, atopic dermatitis with previous or current eczema vaccinatum, and methicillin-resistant S. aureus. Non-Hispanic Caucasian, Non-Hispanic African American, and Mexican American populations will be targeted because they constitute the 3 largest racial/ethnic populations according to the United States Census Bureau 2009 data; however, no racial/ethnic groups will be excluded.
Interferon Responses in Eczema Herpeticum (ADRN-01)
Recent studies have demonstrated that IFNγ generation was significantly decreased after stimulation with HSV ex vivo. The purpose of this study is to determine if deficient IFNγ induction leads to susceptibility to HSV infection in ADEH+ patients. The investigators hypothesize that defective IFNγ responses in peripheral blood mononuclear cells from ADEH+ patients results from aberrant pattern recognition receptors signaling in antigen-presenting cells, resulting in low level production of IL-12, an essential cytokine for IFNγ generation. This study will compare results from 40 ADEH+, 40 ADEH-, and 40 nonatopic participants.
Study procedures will typically be completed in one visit; however, participants may be asked to return for additional unscheduled visit(s) occurring as frequently as every 3 months for the duration of the study to provide an additional blood