Clinical Trial Review

February 2014 | Volume 13 | Issue 2 | Features | 220 | Copyright © February 2014


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

A Clinical Outcomes Protocol of Photon/Proton Beam Radiation Therapy for Carcinoma of the Skin of the Head and Neck With Perineural Invasion

This study is sponsored by the University of Florida. The purpose is to collect information from the questionnaire and your medical records to see what effects the proton radiation has on you and your cancer and collect and analyze morbidity outcomes: Incidence of xerostomia (dry mouth) and tumor control.
The primary outcome measure is to Collect and analyze morbidity outcomes: Incidence of grade 3 or higher xerostomia (dry mouth). Time Frame: 1 year following the completion of radiation therapy. The secondary outcome measure is to collect and analyze tumor control outcomes.
To be considered for this study, the patient must be 18 years of age or older; have carcinoma of the skin of the head and neck region with incidental or symptomatic perineural invasion or biopsy-proven squamous cell carcinoma, and will receive treatment with proton radiation.
table 1

A Phase 3b, Multicenter, Randomized, Placebo- Controlled, Double Blind, Double-Dummy Study of the Efficacy and Safety of Apremilast (CC- 10004), Etanercept, and Placebo, in Subjects With Moderate to Severe Plaque Psoriasis

This study, sponsored by Celgene Corporation, will test the clinical effectiveness and safety of apremilast, etanercept compared with placebo in the same group of patients with moderate to severe plaque psoriasis. Apremilast (CC-10004) is a new oral agent that is under clinical development for the treatment of inflammatory autoimmune disorders, such as psoriatic arthritis, psoriasis, rheumatoid arthritis, and Behçet disease. Etanercept is approved for the treatment of psoriasis; it is the most widely prescribed anti-tumor necrosis factor (TNF) for psoriasis.
The primary outcomes are Apremilast Psoriasis Area and Severity Index-75 (PASI), time frame: Week 16. Proportion of subjects with either apremilast 30 mg twice a day (BID) or placebo who achieve at least a 75% reduction in PASI (PASI-75) at Week 16 from baseline in subjects with plaque type psoriasis or plaque psoriasis
Inclusion Criteria: are males or females, ≥ 18 years of age; diagnosis of chronic, moderate to severe plaque psoriasis for at least 12 months prior to screening, and a candidate for phototherapy and/or systemic (including etanercept) therapy; received an inadequate response, intolerance, or contraindication to at least 1 conventional systemic agent for the treatment of psoriasis; no prior exposure to biologics for treatment of psoriatic arthritis or psoriasis
table 2

Revlite Laser System Compared to the Candela Alex TriVantage System Refractory Mixed Type Melasma

This proof of concept study, sponsored by Cynosure, Inc, will be conducted to assess the aesthetic improvement in refractory mixed type melasma in subjects treated with two FDA 510K approved devices: Q Switched Nd: YAG Laser vs. Alex TriVantage.
Primary outcomes are live assessment of aesthetic levels of improvement using Global Aesthetic Improvement Scale by PI at 1 and 3 months with time frame up to 3 months post last treatment.
To be considered for this study, patients must be subjects with Fitzpatrick Skin Type III-VI or mixed (epidermal and dermal) type melasma diagnosed by Wood's Lamp; subjects who are over the age of 18 years of age; willing and able to comply with study instructions and return to the clinic for required visits; and the subject's melasma has persisted for greater than 6 months and has failed to respond to conventional treatment with hydroquinone cream or other topical lightening agents.