CLINICAL TRIAL REVIEW

November 2011 | Volume 10 | Issue 11 | Feature | 1342 | Copyright © 2011

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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TATTOO REMOVAL

Topical Imiquimod in Conjunction With Nd:YAG Laser for Tattoo Removal
Sponsored by the University of Miami and in collaboration by Graceway Pharmaceauticals, LLC, this study aims to evaluate the efficacy of tattoo removal using topical imiquimod, 5% cream in conjunction with the 1064 nm Nd:YAG laser. This procedure for tattoo removal will be compared to laser removal alone.

The primary and secondary outcomes measure are safe bleaching of tattoo with the timeframe of 14 weeks.

Inclusion criteria are two tattoos no larger than 25cm2, professionally made, with approximately the same age, containing blue/ black ink. Exclusion criteria are hypersensitivity to imiquimod, current sun tan, use of vitamin E, non-steroid anti-inflammatory drugs, coumadin or aspirin for the past 10 days, amateur tattoos, pregnancy, breast-feeding status, immunosuppression, and autoimmune diseases.

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CALCIPHYLAXIS

Evaluation of Efficacy of Lanthanum Carbonate (Fosrenol) in Patients With Calciphylaxis
Sponsored by the University of Wisconsin-Madison and in collaboration with Shire Pharmaceutical Development, this study aims to determine if lanthanum carbonate is effective in treating calciphylaxis by measurement of complete or partial remission of skin lesions. Secondary endpoints will be measured to determine if lanthanum carbonate can lower calcium-phosphorus product levels, intact PTH and mortality. Albumin levels will be measured as a marker of nutritional status and inflammation.

The primary outcome measures are remission of calciphylaxis skin lesions after 12 weeks of therapy as defined by the clinician. The secondary outcome measures are improvement in phosphorous control (target concentrations of 3.5-5.5 mg/dL), which will be monitored to correlate the relationship between phosphorous levels and calciphylaxis. Additionally, secondary outcomes measures are the control of laboratory parameters of intact PTH and albumin. Lastly, demonstration of improved DLQI will be measured.

Inclusion criteria: Participants will have signed a witnessed informed consent, be at least 18 years of age, have chronic renal failure receiving hemodialysis or peritoneal dialysis, diagnosed with calciphylaxis proven by skin biopsy or initial dermatology visit within the previous five years, and have serum phosphorus levels of >4.5 mg/dL.

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ALOPECIA

A Randomized, Double Blind, Placebo Controlled Clinical Trial to Evaluate the Efficacy of Abatacept Costimulatory Blockade in the Treatment of Alopecia Totalis/Universalis
Sponsored by Columbia University, this study will determine if Abatacept will reduce priming of the hair-follicle-specific T cells and thereby reduce hair-follicle-associated infiltration and improve hair growth.

This is a double-blind placebo-controlled study to test the safety and efficacy of Abatacept in the treatment of 64 subjects diagnosed with alopecia totalis or alopecia universalis. Subjects will be randomized 1:1 to the placebo or treatment arm and will receive six months of treatment with the study medication or placebo, followed by a six-month observational period.

The primary outcome measures are the proportion of responders after six months of treatment, defined as 50% or greater hair re-growth from baseline as assessed by Severity of Alopecia Tool (SALT) score at week 24. This is a relatively strict definition for defining responders and non-responders and was chosen to minimize responses in the 'vehicle' arm, in which fewer than 10 percent are expected to achieve this magnitude of hair re-growth spontaneously.

The secondary outcome measures are percent hair re-growth from baseline determined by SALT at weeks 4, 8, 12, 20, and 24 during treatment phase and at weeks 30, 36, 42 and 48 during the observational phase. As secondary endpoints, efficacy will be measured by

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