The study is designed to evaluate the efficacy of etanercept 50 mg subcutaneously (SQ) weekly plus tacrolimus 0.1% topical ointment twice daily compared to etanercept 50 mg SQ weekly plus placebo ointment twice daily.
Full Title of Study: “Double-Blind, Placebo-Controlled, Bilateral Comparison of Topical Tacrolimus 0.1% vs. Placebo Ointment as Adjunctive Therapy for Patients With Moderate to Severe Psoriasis Who Are Candidates for or Poor Responders to Etanercept Therapy”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double
The study is designed to evaluate the efficacy of etanercept 50 mg SQ weekly plus tacrolimus 0.1% topical ointment twice daily compared to etanercept 50 mg SQ weekly plus placebo ointment twice daily. Subjects will be either beginning etanercept therapy or already using a stable dose of etanercept when they begin to apply tacrolimus to half of their body and placebo ointment to the other half. The study is double blinded. Total duration of the study is 12 weeks.
- Drug: Etanercept plus tacrolimus
Clinical Trial Outcome Measures
- Target lesion scoring (on a scale of 0-12) at week 12
- The percentage of lesions having scores of < 2 in the topical tacrolimus and vehicle-treated sites will be assessed.
- Photography of target lesions
- Quarter-body photography
- Static Physician’s Global Assessment (PGA) on each side of each subject’s body
Participating in This Clinical Trial
Gender Eligibility: All
Minimum Age: 18 Years
Maximum Age: N/A
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- University of Medicine and Dentistry of New Jersey
- Overall Official(s)
- Melissa Magliocco, MD, Principal Investigator, UMDNJ – RWJMS
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