Study of Tumor Necrosis Factor Receptor Fusion Protein Etanercept (Enbrel) in Psoriasis of the Hands and/or Feet
Summary
The purpose of this research study is to see how well (compared to placebo) Enbrel® (etanercept) 50 mg twice a week affects plaque psoriasis of the hands and/or feet (Palmoplantar Psoriasis)
Description
This 24-week multicenter study consists of two phases. The first phase is a 12 week, double-blind, randomized trial of etanercept, 50 mg twice weekly versus placebo in subjects with PPP. Subjects who meet the eligibility criteria will be randomized to either 50 mg etanercept twice weekly or placebo. Subcutaneous injections will occur twice weekly at approximately the same time of day over the first 12-week treatment period. The primary efficacy endpoint will be assessed after 12 weeks of treatment. At the end of the first 12 weeks, all subjects will be treated with etanercept 50 mg twice a week (BIW) for an additional 12 weeks.
Study Design
Allocation: Randomized, Control: Placebo Control, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
Conditions
Psoriasis
Intervention
Entercept
Location
UC Irvine Dermatology Clinical Research Center
Irvine
California
United States
92697
Status
Completed
Source
University of California, Irvine
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT00585650
- Information obtained from ClinicalTrials.gov on July 15, 2010
Medical and Biotech [MESH] Definitions
Psoriasis
A common genetically determined, chronic, inflammatory skin disease characterized by rounded erythematous, dry, scaling patches. The lesions have a predilection for nails, scalp, genitalia, extensor surfaces, and the lumbosacral region. Accelerated epidermopoiesis is considered to be the fundamental pathologic feature in psoriasis.
Halcinonide
A glucocorticoid used topically in the treatment of DERMATITIS; ECZEMA; or PSORIASIS. It may cause skin irritation.
Desoximetasone
A topical anti-inflammatory glucocorticoid used in DERMATOSES, skin allergies, PSORIASIS, etc.
Anthralin
An anthracene derivative that disrupts MITOCHONDRIA function and structure and is used for the treatment of DERMATOSES, especially PSORIASIS. It may cause FOLLICULITIS.
Etretinate
An oral retinoid used in the treatment of keratotic genodermatosis, lichen planus, and psoriasis. Beneficial effects have also been claimed in the prophylaxis of epithelial neoplasia. The compound may be teratogenic.
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PubMed Articles
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