Clinical Trial Report

June 2015 | Volume 14 | Issue 6 | Features | 643 | Copyright © June 2015


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have truncal acne severity of PGA grade 3 (moderate) and a minimum of 20 inflammatory lesions and 20 non-inflammatory lesions on the shoulders, anterior chest, and upper back at screening and baseline visits.
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PLAQUE PSORIASIS

DFD06 Cream vs Comp01 Cream HPA Axis Suppression Study in Patients With Moderate to Severe Plaque Psoriasis

This is a randomized, parallel group, open label study whose purpose is to assess the potential for adrenal suppression and systemic drug absorption following multiple dosing with DFD06 cream vs Comp01 cream in subjects with moderate to severe plaque psoriasis. This study will evaluate the potential of DFD06 cream to suppress the hypothalamic-pituitary-adrenal (HPA) axis as compared with Comp01 cream when applied twice daily for 15 days.
Subjects must present with a clinical diagnosis of stable (at least 3 months) plaque psoriasis. They must have psoriasis involving 20% to 50% body surface area, not including the face, scalp, groin, axillae, and other intertriginous areas. They must have an IGA grade of at least 3 (moderate) at the baseline visit.
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MALIGNANT SKIN NEOPLASM

Website Application Based Education and Text Messaging in Improving Skin Wound Care in Patients Undergoing Mohs Surgery

This randomized clinical trial will study how well website application–based education and text messaging works in improving skin wound care in patients undergoing Mohs surgery (a surgical procedure used to treat skin cancer). Website application and text messaging–based education may help patients stick to wound care instructions before and after surgery and lower their anxiety levels, as well as help monitor their activity.
The condition is malignant skin neoplasm and the interventions consist of Mohs surgery, internet-based intervention, telephone-based intervention, educational intervention, and exercise intervention. Patients are randomized to 1 of 4 groups: group 1 (video, text message); group 2 (educational video); group 3 (text message); and group 4 (control). The primary objective is to create a web application that will educate dermatologic surgery patients prior to their operations with educational videos. A secondary objective is to create and evaluate a web-based system to send wound care instructions to patients by text message after their operation.
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ATOPIC DERMATITIS

Bleach Bath Treatment of Adults With Atopic Dermatitis

This is pilot, mechanistic study to address whether bleach baths given to adult subjects with atopic dermatitis or eczema, who are colonized with the bacteria Staphylococcus aureus, will significantly alter their skin microbiome and in so doing improve their skin barrier, diminish expression of inflammatory proteins in the skin, and improve itch. To answer these questions the investigators will perform a 3-month, pilot, investigator-initiated, single-center, open-label clinical study allowing us to test the following hypothesis: 1) that bleach baths will normalize skin barrier function; 2) that bleach baths will diminish the local inflammatory response in the skin; and 3) that bleach baths will improve validated measures of itch (also called pruritus).
Studies have demonstrated a remarkable clinical improvement in atopic dermatitis subjects who take bleach baths 2 times per week for 3 months. However, the mechanism by which these bleach baths improve the disease remains entirely unknown. This study will assess the effects bleach baths have on bacteria that can and cannot be cultured using new molecular biologic tools that have shown us that the skin is home to thousands of different microbial species. The investigators will also determine whether bleach baths affect skin barrier integrity and the cutaneous expression of lymphocyte-derived cytokines that are thought to cause the skin inflammation in subjects with atopic dermatitis.
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