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Sponsors and Collaborators: |
University of Alberta 3M |
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Information provided by: | University of Alberta |
ClinicalTrials.gov Identifier: | NCT00230373 |
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).
Condition | Intervention | Phase |
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Morphea |
Drug: imiquimod 5% cream (Aldara) |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Non-Randomized, Open Label, Placebo Control, Single Group Assignment, Safety/Efficacy Study |
Official Title: | Evaluation of the Efficacy and Safety of Imiquimod 5% Cream in Plaque-Type Morphea: A Pilot, Prospective Open-Label Study |
Estimated Enrollment: | 20 |
Study Start Date: | November 2005 |
Estimated Study Completion Date: | June 2007 |
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Canada, Alberta | |
University of Alberta | |
Edmonton, Alberta, Canada, T6G 2G3 | |
Dr. Loretta Fiorillo's clinic | |
Red Deer, Alberta, Canada, T4N 6R2 | |
Dr. Marlene Dytoc's clinic | |
Edmonton, Alberta, Canada, T6G 2C8 |
Principal Investigator: | Marlene T Dytoc, MD PhD | University of Alberta |
Study ID Numbers: | 04CA05-IMIQ |
Study First Received: | September 28, 2005 |
Last Updated: | June 17, 2008 |
ClinicalTrials.gov Identifier: | NCT00230373 |
Health Authority: | Canada: Health Canada |
Localized scleroderma |
Skin Diseases Interferons Connective Tissue Diseases |
Imiquimod Localized scleroderma Scleroderma, Localized |
Interferon Inducers Immunologic Factors Antineoplastic Agents Therapeutic Uses |
Physiological Effects of Drugs Adjuvants, Immunologic Pharmacologic Actions |