Morphea is very hard to treat. In a small number of adult patients, Imiquimod has proven to be beneficial in decreasing the thickness of the morphea plaques , while improving their appearance. There are no studies to date proving its safety and efficacy in children with this disease. We propose to conduct a pilot study to assess to potential efficacy and relative safety of Imiquimod in children with plaque morphea.
Design: Prospective, open label, pilot study Settings: The Hospital for Sick Children, Specialized Morphea Clinic Study population: * Children 6-18 years of age * Plaque morphea measuring less than 10 cm2 in diameter ( for children with multiple lesions, only one will be treated) Intervention: Topical imiquimod applied 3-5 times a week for 6 months Outcome measures: Decrease in the thickness of the skin by clinical scores and ultrasonography Duration of the study: 12 months ( 2 baseline visits, 1 intervention visit, 5 follow-up visits)
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
10
Treatment will last for 36 weeks. Patients will be instructed to apply Imiquimod three times per week for 4 weeks. If no local side effects are noted at the 4 week- follow-up visit, the frequency of the application will be increased to 5 weekly applications.
The Hospital for Sick Children
Toronto, Ontario, Canada
Percent improvement in the thickness of the skin
Time frame: 4 weeks, 12 weeks, 24 weeks, 36 weeks, and 48 weeks
Frequency of side-effects
Time frame: 48 weeks
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