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

University of Alberta

Status and phase: Withdrawn; Phase 3

Conditions: Morphea

Treatments: Drug: imiquimod 5% cream (Aldara)

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT00230373

04CA05-IMIQ

Details and patient eligibility

About

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).

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)