Imiquimod 5% Cream in Plaque-Type Morphea: A Pilot, Prospective Open-Label Study
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).
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||Evaluation of the Efficacy and Safety of Imiquimod 5% Cream in Plaque-Type Morphea: A Pilot, Prospective Open-Label Study|
- 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.
- Any adverse outcome is recorded.
|Study Start Date:||November 2005|
|Estimated Study Completion Date:||June 2007|
Please refer to this study by its ClinicalTrials.gov identifier: NCT00230373
|University of Alberta|
|Edmonton, Alberta, Canada, T6G 2G3|
|Dr. Marlene Dytoc's clinic|
|Edmonton, Alberta, Canada, T6G 2C8|
|Dr. Loretta Fiorillo's clinic|
|Red Deer, Alberta, Canada, T4N 6R2|
|Principal Investigator:||Marlene T Dytoc, MD PhD||University of Alberta|