Imiquimod in Children With Plaque Morphea

Evaluation of the Efficacy and Safety of the Imiquimod 5% Topical Cream in Plaque Morphea: A Prospective, Multiple Baseline, Open Label Pilot Study

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)

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