Status:
COMPLETED
Imiquimod in Children With Plaque Morphea
Lead Sponsor:
The Hospital for Sick Children
Conditions:
Scleroderma, Localized
Eligibility:
All Genders
6-18 years
Phase:
PHASE3
Brief Summary
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 a...
Detailed Description
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...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Age at diagnosis 6 to 18 years of age
- Morphea plaques
- Female subjects of childbearing potential must have a negative urine pregnancy test
- Signed consent/assent form
- Exclusion criteria:
- Children who received topical corticosteroids, tacrolimus, vitamin D derivatives (calcipotriol, calcipotriol-betamethasone dipropionate) to the affected area in the previous four weeks
- Children who were previously treated with Imiquimod on the affected areas
- Children with no demonstrable ultrasonographic changes at the baseline evaluation
- Children with evidence of skin breakdown on the proposed area to be treated at the time of enrollment due to potential increased absorption of the medication through impaired skin barrier
- Female subjects of childbearing potential who do not agree to practice effective birth control methods for the duration of the study
- Children who are/were (in the past 6 months) treated with systemic medications such as methotrexate and/or systemic corticosteroids
- Co-morbidities: systemic sclerosis, juvenile rheumatoid arthritis, other systemic diseases
Exclusion
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2009
Estimated Enrollment :
10 Patients enrolled
Trial Details
Trial ID
NCT00147771
Start Date
September 1 2005
End Date
September 1 2009
Last Update
August 2 2013
Active Locations (1)
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1
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8