CLINICAL TRIAL REVIEW 

February 2017 | Volume 16 | Issue 2 | Feature | 183 | Copyright © 2017

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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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ACTINIC KERATOSIS

Safety and Efficacy of Ingenol Mebutate Gel 0.015% for the Treatment of Actinic Keratosis on the Face in Solid Organ Transplant RecipientsActinic keratoses (AK) are patches of dysplastic keratinocytes arising in sun-damaged skin. These lesions are precursors to cutaneous squamous cell carcinoma (SCC), and are treated to prevent progression to SCC. First-line therapy for AK includes cryotherapy and curettage, which target clinically visible lesions but do not address the subclinical lesions in the field of ultraviolet radiation damage. Field therapy includes topical chemotherapy, immunotherapy, and photodynamic therapy.Ingenol mebutate is the active compound found in Euphorbia peplus sap, and has been approved for treatment of AK in immunocompetent patients. Ingenol mebutate 0.015% is favored over other topical treatments for the treatment of AK on the face due to the brief treatment course, high clearance rate, and resolution without sequelae.Solid organ transplant recipients (OTR) have a high incidence of AK as well as a high risk of developing SCC, and requirefrequent field therapy. In addition, OTR generally have a higher burden of AK and require treatment of a larger surface area than the 25 cm2 area labeled for ingenol mebutate 0.015%. The investigators plan to investigate the safety and efficacy of ingenol mebutate 0.015% in OTR, with a treatment area of up to 100 cm2.Table1

PSORIASIS

Videocapillaroscopy Assessment During Systemic Agent Therapy in PsoriasisThe aim of this study is to determine if videocapillaroscopy could be used as an objective and reliable method to assesspsoriasis severity, and to document improvement during treatment by measuring changes in vascular features.This is a single-center, prospective, observational study that will recruit subjects from Northwestern University to examine the degree of improvement of psoriatic plaques during systemic therapy treatment. Thirty patients with aconfirmed diagnosis of “active” psoriasis treated with a single systemic agent will be recruited from the Northwestern Medical Faculty Foundation Dermatology clinic. The study population will include 15 patients receiving adalimumaband 15 patients receiving methotrexate. Eight visits will be completed for each subject: visit 0 (baseline) and visits 1 to 8 (weeks 2, 4, 6, 8, 12, 16, and 24). At each of the 8 visits, a dermatologic physical examination will be performed, including Psoriasis Area and Severity Index and Physician’s Global Assessment scores.Table2

NON-MELANOMA SKIN CANCER

Topical Chemoprevention of Skin Cancer BiomarkersBiomarkers are molecules that are found in the body and inside of cells. Some biomarkers are associated with specific diseases such as skin cancer. In this study, 2 topical medications will be evaluated: diclofenac and α-difluoromethylornithine (DFMO), to test how well these work to prevent the development of nonmelanoma skin cancers by reversing certain biomarkers in the skin. This study will also look at the optimal dose of a medicationin a small number of people.Both topical medications are already FDA approved, used alonevor in combination with a placebo comparator. The purpose of the study is to see if diclofenac and DMFO can be applied daily, or if they need to be applied twice per day each in order to achieve the desired results.Men and women (greater than equal to 18 y) who have been seen as patients in the Dermatology Clinic at the University of Alabama at Birmingham with a history of basal cell or squamous cell carcinoma of

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