Imiquimod in Children With Plaque Morphea

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”

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)

Intervention(s) in this Clinical Trial

• Drug: Imiquimod 5% cream
  • 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.

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1

Primary Measures

• Percent improvement in the thickness of the skin
  • Time Frame: 4 weeks, 12 weeks, 24 weeks, 36 weeks, and 48 weeks
    Safety Issue?: No

Secondary Measures

• Frequency of side-effects
  • Time Frame: 48 weeks
    Safety Issue?: No

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

Gender Eligibility for this Clinical Trial: Both

Minimum Age for this Clinical Trial: 6 Years

Maximum Age for this Clinical Trial: 18 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Investigator: The Hospital for Sick Children Other

Overall Clinical Trial Officials and Contacts

Elena Pope, MD Principal Investigator The Hospital for Sick Children  

Information obtained from ClinicalTrials.gov on February 12, 2012

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00147771

Study ID Number: 1000007595

ClinicalTrials.gov Identifier: NCT00147771

Health Authority: Canada: Health Canada