Status:
WITHDRAWN
Imiquimod 5% Cream in Plaque-type Morphea: A Pilot, Prospective Open-label Study
Lead Sponsor:
University of Alberta
Collaborating Sponsors:
3M
Conditions:
Morphea
Eligibility:
All Genders
18+ years
Phase:
PHASE3
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 pla...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
November 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2007
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00230373
Start Date
November 1 2005
End Date
June 1 2007
Last Update
April 23 2015
Active Locations (3)
Enter a location and click search to find clinical trials sorted by distance.
1
Dr. Marlene Dytoc's clinic
Edmonton, Alberta, Canada, T6G 2C8
2
University of Alberta
Edmonton, Alberta, Canada, T6G 2G3
3
Dr. Loretta Fiorillo's clinic
Red Deer, Alberta, Canada, T4N 6R2