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

NCT ID: NCT00230373

Last Updated: 2015-04-23

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-11-30
• Study Completion Date: 2007-06-30

Brief 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).

Conditions

Morphea

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

imiquimod 5% cream (Aldara)

Intervention Type: DRUG

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

3M

INDUSTRY

Sponsor Role: collaborator

University of Alberta

OTHER

Sponsor Role: lead

Principal Investigators

Marlene T Dytoc, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Alberta

Locations

Dr. Marlene Dytoc's clinic

Edmonton, Alberta, Canada

University of Alberta

Edmonton, Alberta, Canada

Dr. Loretta Fiorillo's clinic

Red Deer, Alberta, Canada

Countries

Canada

Other Identifiers

04CA05-IMIQ

Identifier Type: -

Identifier Source: org_study_id