Imiquimod in Children With Plaque Morphea

Scleroderma, Localized Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00147771
• Other study ID #: 1000007595
• Status: Completed
• Phase: Phase 3
• First received: September 2, 2005
• Last updated: August 1, 2013
• Start date: September 2005
• Est. completion date: September 2009

Study information

• Verified date: August 2013
• Source: The Hospital for Sick Children
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 2009
• Est. primary completion date: September 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Scleroderma, Diffuse
• Scleroderma, Localized
• Scleroderma, Systemic

Intervention

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.

Locations

Country	Name	City	State
Canada	The Hospital for Sick Children	Toronto	Ontario

Sponsors (1)

Lead Sponsor	Collaborator
The Hospital for Sick Children

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percent improvement in the thickness of the skin		4 weeks, 12 weeks, 24 weeks, 36 weeks, and 48 weeks	No
Secondary	Frequency of side-effects		48 weeks	No