Imiquimod 5% Cream in Plaque-type Morphea: A Pilot, Prospective Open-label Study
Status:
Withdrawn
Trial end date:
2007-06-01
Target enrollment:
Participant gender:
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).