Clinical Trial: Imiquimod 5% Cream in Plaque-type Morphea: A Pilot, Prospective Open-label Study

Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional

Official Title: Evaluation of the Efficacy and Safety of Imiquimod 5% Cream in Plaque-type Morphea: A Pilot, Prospective Open-label Study

Brief Summary: Localized scleroderma or morphea is a fibrotic disease, imiquimod induces cytokines which inhibit fibrotic activity . We propose that topical imiquimod 5% cream is efficacious and safe in treating plaque-type morphea. Twenty adults will be enrolled for a pilot study. A screening and baseline clinic visit will be required for each patient enrolled in the study. Each visit will involve completing a medical history, skin examination, digital pictures, histologic examination if the patient consents and an ultrasonographic score. One morphea plaque will be treated with topical imiquimod 5% cream, and another morphea lesion with vehicle cream. Patients will be asked about side effects (local and systemic). Patients will be followed up in the clinic at 3, 6 and 9 months of therapy, and 3 months following end of treatment period (month 12).

Detailed Summary:
Sponsor: University of Alberta

Current Primary Outcome: The main outcome of this study is to evaluate the efficacy of imiquimod cream in improving morphea plaques. Improvement of skin induration will be measured by percent improvement in the skin induration as assessed radiologically by ultrasonography score.

Original Primary Outcome: Same as current

Current Secondary Outcome: Any adverse outcome is recorded.

Original Secondary Outcome: Same as current

Information By: University of Alberta

Dates:
Date Received: September 28, 2005
Date Started: November 2005
Date Completion: June 2007
Last Updated: April 22, 2015
Last Verified: April 2015