CLINICAL TRIAL REVIEW
October 2016 | Volume 15 | Issue 10 | Feature | 1273 | Copyright © 2016
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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Defining the Skin and Blood Biomarkers of Pediatric Atopic Dermatitis
Atopic dermatitis (AD), also known as eczema, is the most common inflammatory skin disorder of children, affecting 10% to 20% of children and 1% to 2% of adults.This skin disorder can be associated with unbearable itchiness and an increased susceptibility to skin infections. The cause of AD is currently poorly understood; therefore, there are no targeted treatment options at present. There have been recent studies in adults with AD that explain the cause and give new routes to investigate treatment options, but no major studies in this arena have been done in children. This study will evaluate the skin and blood biomarkers that are found in pediatric AD and compare them with adult AD.Hypothesis: The immune system worsens the skin barrier issues that are common in atopic dermatitis. The researchers believe that there are similar immune and skin abnormalities in adult vs pediatric atopic dermatitis. Finally, blood levels of the activated molecules in atopic dermatitis can serve as surrogates for skin immune activation and will correlate with disease severity.
Curing Atopic Dermatitis in Children With a Commercial Medical Device and Maintaining Healthy Skin by Using a New Cosmetic Product
This multicenter, 2-phase exploratory clinical trial will examine efficacy and safety after open-label topical administration of a medical device (Bepanthen Itch Relief Cream) for treatment of acute flare-ups, followed by topical administration of a new cosmetic bepanthen product or a cosmetic comparator in a parallel-group, randomized, investigator-blinded care phase for skin care in the remission phase in infants with mild atopic dermatitis.Eligibility for this study includes children from 1 month to 4 years, of both sexes, with skin types 1 to 4 according to Fitzpatrick, who have mild atopic dermatitis presenting a maximum SCORAD of 25 (at screening and baseline).
Randomized Controlled Trial of an Eczema Care Plan
The objectives of this study are to increase families' understanding of eczema and to improve eczema management in the primary care setting. The researchers have created an "Eczema Care Plan" similar to those used in the management of asthma. It gives specific instructions about medications, bathing, and moisturizing, as well as when to seek further treatment. They will conduct a randomized controlled trial of the plan in Primary Care at Longwood for a 10-month period. Specifically, they aim to (1) decrease eczema severity; (2) improve patient quality of life; and (3) increase parental knowledge and confidence about eczema management. They also plan to track provider uptake and documentation of the plan, and elicit feedback from parents and providers on its use and feasibility.
Role of Angiogenesis in Dermatologic Diseases: A Potential Therapeutic Target
The researchers believe that pro-angiogenic factors are upregulated in a wide range of dermatologic diseases, including port wine stains, hemangiomas, angiofibromas, Kaposi's sarcoma, angiosarcoma, scars, rosacea, and psoriasis.The study will consist of performing immunohistochemistry and/or microarray analysis and/or quantitative polymerase