Clinical Trial: Imiquimod in Children With Plaque Morphea
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: Evaluation of the Efficacy and Safety of the Imiquimod 5% Topical Cream in Plaque Morphea: A Prospective, Multiple Baseline, Open Label Pilot Study
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 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.
Detailed Summary:
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)
Sponsor: The Hospital for Sick Children
Current Primary Outcome: Percent improvement in the thickness of the skin [ Time Frame: 4 weeks, 12 weeks, 24 weeks, 36 weeks, and 48 weeks ]
Original Primary Outcome: Percent improvement in the thickness of the skin
Current Secondary Outcome: Frequency of side-effects [ Time Frame: 48 weeks ]
Original Secondary Outcome: Frequency of side-effects
Information By: The Hospital for Sick Children
Dates:
Date Received: September 2, 2005
Date Started: September 2005
Date Completion:
Last Updated: August 1, 2013
Last Verified: August 2013
