Clinical trial NCT00147771: Imiquimod in Children With Plaque Morphea
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Scleroderma, Localized
Keywords: localized scleroderma
morphea
imiquimod
pediatrics
Lead sponsor: The Hospital for Sick Children
Sponsor class: OTHER
First posted: 2005-09-07
Enrollment: 10
Sex: ALL
Minimum age (years): 6
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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)

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

Primary outcomes:
measure: Percent improvement in the thickness of the skin
timeFrame: 4 weeks, 12 weeks, 24 weeks, 36 weeks, and 48 weeks
Secondary outcomes:
measure: Frequency of side-effects
timeFrame: 48 weeks
Other outcomes:
Locations:
city: Toronto
country: Canada
facility: The Hospital for Sick Children
state: Ontario
Study officials:
affiliation: The Hospital for Sick Children
name: Elena Pope, MD
role: PRINCIPAL_INVESTIGATOR
References: