Imiquimod in Children With Plaque Morphea

T

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

Trial design

Primary purpose

Treatment

Allocation

Non-Randomized

Interventional model

Single Group Assignment

Masking

None (Open label)

10 participants in 1 patient group

1
Experimental group
Treatment:
Drug: Imiquimod 5% cream

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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