Imiquimod in Children With Plaque Morphea

• Status: Completed
• Trial end date: 2009-09-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The Hospital for Sick Children
• Treatments: Imiquimod

Criteria

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