Imiquimod in Children With Plaque Morphea

NCT ID: NCT00147771

Last Updated: 2013-08-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2005-09-30
• Study Completion Date: 2009-09-30

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)

Conditions

Scleroderma, Localized

Keywords

localized scleroderma; morphea; imiquimod; pediatrics

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1

Group Type: EXPERIMENTAL

Imiquimod 5% cream

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: DRUG

Eligibility 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

• Minimum Eligible Age: 6 Years
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The Hospital for Sick Children

OTHER

Sponsor Role: lead

Responsible Party

Elena Pope

Head, Section of Dermatology

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Elena Pope, MD

Role: PRINCIPAL_INVESTIGATOR

The Hospital for Sick Children

Locations

The Hospital for Sick Children

Toronto, Ontario, Canada

Countries

Canada

Other Identifiers

1000007595

Identifier Type: -

Identifier Source: org_study_id