Clinical Trial Review

August 2011 | Volume 10 | Issue 8 | Features | 936 | Copyright © August 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.

PSORIASIS

T Cell Repertoire Analysis of Immune Mediated Skin Diseases

Sponsored by University of California, Davis. This study is designed to identify the cells of the immune system that cause skin disease such as psoriasis and mycosis fungoides. Blood samples from many patients will be compared in hopes of finding common cells and molecules responsible for skin diseases. Results of this study will increase our knowledge about immune mediated skin disease.
Peripheral blood with be collected from volunteers with psoriasis, mycosis fungoides and age matched controls. Fifteen tablespoons of blood will be collected prior to the initiation of treatment and again after the patient shows a clinical response to treatment. The time between blood draws will be no less than 3 months. There will be no more than two blood draws per patient. Blood samples will be used to determine the patient's HLA haplotype via PCR and DNA sequencing. After the patient's haplotype has been established the activated T cell repertoire will be analyzed for clonal expansions. Clonal expansions in the T cell repertoire will be determined by immunoscope analysis, which is a PCR based technique
Status: Currently recruiting participants as of June 2011.
ClinicalTrials.gov identifier: NCT00368784
table 1

ALOPECIA

Dutasteride Versus Placebo and Finasteride in Men With Androgenetic Alopecia

Sponsored by GlaxoSmithKline. The purpose of this six month study is to show that dutasteride is safe and more effective than placebo, and at least as safe and effective as finasteride in treating hair loss in men with androgenetic alopecia. Three doses of dutasteride will be investigated.
Status: Currently recruiting participants as of July 2011.
ClinicalTrials.gov identifier: NCT01231607
table 2

Safety and Efficacy Study of Bimatoprost in the Treatment of Women With Female Pattern Hair Loss

Sponsored by Allergan. This study will evaluate the safety and efficacy of 3 doses of bimatoprost solution compared with vehicle and over-the-counter (OTC) minoxidil 2% solution in women with female pattern hair loss. All treatments will be provided in a double-blinded fashion except for minoxidil 2% solution which will be provided open-label.
Status: Not yet open for patient recruitment.
ClinicalTrials.gov identifier: NCT01325350
table 3

START: Swiss Taxotere Alopecia Prevention Trial

Sponsored by Sanofi-Aventis. Primary objective: Rate of complete chemotherapy induced alopecia (WHO grade III or IV, physician grading). Secondary objectives: Compliance with scalp cooling procedure; Received number of cycles of chemotherapy in each subgroup; Patient perception of scalp cooling procedure; and Side effects of scalp cooling systems.
Status: Currently recruiting patients as of May 2011.
ClinicalTrials.gov identifier: NCT01008774
table 4