The purpose of this research study is to see how well (compared to placebo) Enbrel® (etanercept) 50 mg twice a week for 12 weeks affects plaque psoriasis of the hands and/or feet (palmoplantar psoriasis).
This multicenter investigation is a 12 week, double-blind, randomized trial of etanercept, 50 mg twice weekly versus placebo in subjects with palmoplantar psoriasis (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 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 patients (both treatment and placebo arms) will be treated with etanercept 50 mg twice a week (BIW) for an additional 12 weeks.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
20
Subcutaneous injections 50 mg Etanercept will occur twice weekly over a 12-week treatment period.
Placebo injections twice weekly for 12 weeks.
UC Irvine Dermatology Clinical Research Center
Irvine, California, United States
Wake Forest University School of Medicine
Winston-Salem, North Carolina, United States
Dermatology Associates, PLLC
Seattle, Washington, United States
The Number of Subjects Who Achieve a 50% Reduction in the Palmoplantar Psoriasis Severity Index at 12 Weeks.
Psoriasis area and severity index (PASI) is the most widely used tool for the measurement of severity of psoriasis. This tool is used to assess the skin lesions of the entire body however, the palmoplantar psoriasis severity index (PPPASI) is a modified form of the the PASI that is assessed for skin lesions of the hands and feet only. The severity is estimated by three clinical signs: erythema induration and desquamation. Severity parameters are measured on a scale of 0 to 4, with 4 being the most severe.
Time frame: Week 12
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