Official Title: “Evaluation of the Efficacy and Safety of 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 Type: Interventional

Study Design: Treatment, Non-Randomized, Open Label, Placebo Control, Single Group Assignment, Safety/Efficacy Study

Intervention(s) in this Clinical Trial

• Drug: imiquimod 5% cream (Aldara)

Primary Measures

• 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.

Secondary Measures

• Any adverse outcome is recorded.

Inclusion Criteria:

• Adults and children > 6 years with plaque-type morphea
• Subject has not participated in previous study involving imiquimod for three months
• In the investigator's judgement, imiquimod treatment may benefit the patient over conventional treatment
• Subject has provided informed written consent
• Female subjects of childbearing potential have a pregnancy urine test that is negative prior to treatment
• Sexually active subjects agree to practice effective birth control throughout the duration of the study

Exclusion Criteria:

• Patients with a non-morphea skin disorder in the region of interest
• Subjects previously undergoing morphea therapy within four weeks of the study
• Subjects have a known hypersensitivity to imiquimod or component of the cream preparation
• Subjects who are pregnant or nursing

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: N/A

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: University of Alberta

Overall Clinical Trial Officials and Contacts

Marlene T Dytoc, MD PhD Principal Investigator University of Alberta  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00230373

Study ID Number: 04CA05-IMIQ

ClinicalTrials.gov Identifier: NCT00230373

Health Authority: Canada: Health Canada