Imiquimod in Children With Plaque Morphea

Phase 3

Completed

• Conditions: Scleroderma, Localized
• Interventions: Drug: Imiquimod 5% cream

• Registration Number: NCT00147771
• Lead Sponsor: The Hospital for Sick Children

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 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 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)

Study Timeline

• Study Start: 2005-09
• Study First Submitted: 2005-09-02
• Study First Submitted QC: 2005-09-02
• Study First Posted: 2005-09-07
• Primary Completion: 2009-09
• Study Completion: 2009-09
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-01
• Last Update Posted: 2013-08-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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 Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
1	Imiquimod 5% cream	-

Primary Outcome Measures

Name	Time	Method
Percent improvement in the thickness of the skin	4 weeks, 12 weeks, 24 weeks, 36 weeks, and 48 weeks

Secondary Outcome Measures

Name	Time	Method
Frequency of side-effects	48 weeks

Trial Locations

Locations (1)

The Hospital for Sick Children; 🇨🇦 Toronto, Ontario, Canada