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

Morphea Clinical Trial

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

Status Withdrawn

Clinical Trial 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).

Clinical Trial Description

n/a

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Morphea
• Scleroderma, Localized

• NCT number: NCT00230373
• Study type: Interventional
• Source: University of Alberta
• Status: Withdrawn
• Phase: Phase 3
• Start date: November 2005
• Completion date: June 2007