Imiquimod in Children With Plaque Morphea

The Hospital for Sick Children

Status and phase

Completed

Phase 3

Conditions

Scleroderma, Localized

Treatments

Drug: Imiquimod 5% cream

Study type

Interventional

Funder types

Other

Identifiers

NCT00147771

1000007595

Details and patient eligibility

About

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.

Full 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)

Enrollment

10 estimated patients

Sex

All

Ages

6 to 18 years old

Volunteers

No Healthy Volunteers

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