Clinical Trial Review

September 2011 | Volume 10 | Issue 9 | Feature | 1077 | 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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ALOPECIA

Safety and Efficacy of Clobetasol Propionate 0.05% E Foam in Alopecia

Sponsored by Callender Center for Clinical Research. The purpose of this study is to ascertain the safety and efficacy of Clobetasol Propionate 0.05% Emollient Foam in the treatment of central centrifugal cicatricial alopecia. Clobestasol Propionate 0.05% Emollient Foam is an FDA-approved and marketed topical corticosteroid for the treatment of the inflammatory and pruritic manifestations of moderate-to-severe corticosteroid-responsive dermatoses of the scalp. Many studies found the foam to be less irritating than the original formulation.

The primary outcome measures will be improvement of pruritis, tenderness and pain. The secondary outcome measures will be absence of inflammation on biopsy.

Inclusion criteria: Patients with CCCA, treated or untreated; score of 0-1 on scale/questionnaire; 18 years of age or older; women of African descent.

table 1

FUNGOIDES/SÉZARY SYNDROME

Study of Human Monoclonal Antibody to Treat Mycosis Fungoides and Sézary Syndrome

Sponsored by TenX BioPharma. The purpose of this study is to determine the efficacy of the drug, HuMax-CD4, in patients with mycosis fungoides (MF) and sézary syndrome who are intolerant to or do not respond to treatment with Targretin® and one other standard therapy.

The primary outcome measure will be PGA score. Inclusion criteria: A biopsy compatible with the diagnosis of MF and sézary syndrome with a CD4 positive phenotype within six months of study entry; refractory to or intolerant to at least two prior therapies, one being Targretin (or combinations hereof); signed informed consent.

table 2

PEMPHIGUS VULGARIS

Randomized Trial of IVIg With or Without Cyclophosphamide in Pemphigus

Sponsored by the Food and Drug Administration (FDA). The purpose of this study is to compare two standard treatments for pemphigus to determine which more effectively improves the clinical manifestations of the disease and decreases serum level of the autoantibodies which cause the disease.

The primary outcome measures will be clinical outcome: extent and severity of disease and serum levels of pemphigus antibodies. The secondary outcome measures will be toxicity of treatment: measured in renal toxicity, myelosuppression or hepatic toxicity and the ability to be weaned off steroids.

Inclusion criteria: Lesions consistent with pemphigus foliaceus or vulgaris; diagnosis confirmed by histology and IIF ≥40 within past month; on ≥20 mg/day of prednisone per day for two weeks or ≥80 mg/day for one week; women of childbearing potential negative HCG obtained two weeks prior to first IVIg; agrees to two acceptable forms of contraception if randomized to cyclophosphamide group; normal organ function confirmed by CBC, UA, LFTs and Ig levels within defined inclusion criteria; responds yes to at least one of the following criteria: persistence of clinical manifestations of disease despite steroid treatment, flare in disease activity after an attempt at steroid tapering, failure of established lesions to heal, rapidly progressive disease, conventional therapy is relatively contraindicated (i.e., side effects, co-morbid conditions), systemic infections, peptic ulcers, osteoporosis, hypertension, cataracts or others.

table 3

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