Clinical Trial Review

February 2013 | Volume 12 | Issue 2 | Feature | 239 | Copyright © 2013

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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DERMATOTILLOMANIA

A Double-Blind, Placebo-Controlled Study of N-Acetyl Cysteine in Pathologic Skin Picking

Sponsored by the University of Chicago, the goal of the proposed study is to evaluate the comparative efficacy of N-acetyl cysteine (NAC) to placebo in pathologic skin picking (PSP). PSP involves repetitive, ritualistic, or impulsive picking of otherwise normal skin leading to tissue damage, personal distress, and impaired functioning. Although skin picking has been described in the medical literature for longer than a century, it remains a poorly understood psychiatric issue and often goes undiagnosed and untreated.

Picking behavior does not by itself suggest a psychiatric disorder. Pathology exists in the focus, duration and extent of the behavior, as well as the reasons for picking, associated emotions, and resulting problems. Patients with PSP report thoughts of picking or impulses to pick that are irresistible, intrusive and/or senseless. These thoughts, impulses, or behaviors also cause marked distress for patients and significantly interfere with other activities. Unlike normal picking behavior, the pathologic form of skin picking is recurrent and usually results in noticeable skin damage.

Thirty subjects with PSP will receive 12 weeks of double-blind treatment with NAC or matching placebo. The hypothesis to be tested is that NAC will be more effective than placebo in patients with PSP. The proposed study will provide needed data on the treatment of an often-disabling disorder that currently lacks a clearly effective treatment.

Subjects aged 18 to 65 years with a current diagnosis of PSP for at least 6 months’ duration are eligible for inclusion in this study. Exclusion criteria include: unstable medical illness or clinically significant abnormalities on prestudy laboratory tests or physical examination; history of seizures; myocardial infarction within 6 months; current pregnancy or lactation, or inadequate contraception in women of childbearing potential; need for medication other than NAC with possible psychotropic effects or unfavorable interactions with NAC; clinically significant suicidality (score or 3 or 4 on item 3 of the Hamilton Depression Rating Scale); lifetime history of bipolar disorder type I, dementia, or schizophrenia or any other psychotic disorder; current or recent (past 3 months) substance abuse or dependence; illegal substance use within 2 weeks of study initiation; initiation of pharmacotherapy, psychotherapy, or behavior therapy from a mental health professional within 3 months before study baseline for the treatment of PSP; previous treatment with NAC; treatment with investigational medication or depot neuroleptics within 3 months, with fluoxetine within 6 weeks, or with other psychotropics within 2 weeks before study baseline; and asthma (given possible worsening of asthma due to NAC).

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ONYCHOMYCOSIS

Treatment of Onychomycosis Using a 0.65 Millisecond Pulsed Nd:YAG 1,064-nm Laser

Sponsored by Stanford University, the investigators for this study would like to test the treatment of onychomycosis using a 0.65 millisecond (ms) pulsed 1,064-nm laser fitted with a special onychomycosis handpiece. The investigators will compare the success rates of those receiving laser treatments with untreated patients. This study will provide a clinical basis for determining the relative effectiveness of an increasingly utilized treatment method.

Current antifungal treatments have low cure rates and numerous side effects. A new treatment method, pulsed laser, has been purported to have high rates of treatment in a much shorter time frame than other treatments. While the treatment method has become increasingly popular, studies of its efficacy are few. The investigators hope to learn the cure rate of a novel treatment that is being used by more and more patients. This knowledge will be essential to physicians as they consider employing this new technology in their treatment methods.

The primary outcome measure will be the number of adverse events (eg, pain during or post–laser therapy, rash) over 1 year. The secondary outcome measure will be the proximal clearance of fungus on the nails. In the treatment arm, at the first visit, the patient will come into clinic for initial laser treatment with neodymium-doped:yttrium aluminum garnet (Nd:YAG) 1,064-nm laser fitted with a special handpiece. Two weeks after the initial laser treatment, the patient will be seen for second treatment with Nd:YAG 1,064-nm laser fitted with a special handpiece. In the placebo group, at the first visit, no treatment will be given. Two weeks after the initial visit, the patient will be seen again.

Subjects aged 18 years or older with onychomycosis on at least one toe who consent to the use of their toenail clippings for research are eligible for inclusion in this study. Subjects will be excluded who are older than 75 years old, have current immunosuppression (eg, cancer, autoimmune disease) or are taking immunosuppressive drugs, or are pregnant.

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