Etanercept With Tacrolimus for Psoriasis

Phase 2

Completed

• Conditions: Psoriasis

• Registration Number: NCT00134394
• Lead Sponsor: University of Medicine and Dentistry of New Jersey

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2005-08-22
• Study First Submitted QC: 2005-08-23
• Study First Posted: 2005-08-24
• Study Completion: 2007-12
• Status Verified: 2008-08
• Last Update Submitted: 2008-08-06
• Last Update Posted: 2008-08-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
The percentage of lesions having scores of < 2 in the topical tacrolimus and vehicle-treated sites will be assessed.
Target lesion scoring (on a scale of 0-12) at week 12

Secondary Outcome Measures

Name	Time	Method
Photography of target lesions
Quarter-body photography
Static Physician's Global Assessment (PGA) on each side of each subject's body

Trial Locations

Locations (1)

UMDNJ Psoriasis Center of Excellence; 🇺🇸 New Brunswick, New Jersey, United States