Imiquimod in Children With Plaque Morphea

NCT00147771 | Completed Phase 3 DMC

• 1 other identifier: 1000007595
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

Scleroderma, Localized

Keywords

localized scleroderma; morphea; imiquimod; pediatrics

Outcome Measures

Primary Outcomes (1)

• Percent improvement in the thickness of the skin

  4 weeks, 12 weeks, 24 weeks, 36 weeks, and 48 weeks

Secondary Outcomes (1)

• Frequency of side-effects

  48 weeks

Study Arms (1)

1

EXPERIMENTAL

Drug: Imiquimod 5% cream

Interventions

Imiquimod 5% cream 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.

1

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• The Hospital for Sick Children: lead

Study Sites (1)

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

MeSH Terms

Conditions

Scleroderma, Localized

Interventions

Imiquimod

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Intervention Hierarchy (Ancestors)

Aminoquinolines; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Elena Pope, MD

  The Hospital for Sick Children

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head, Section of Dermatology

Study Record Dates

• First Submitted: September 2, 2005
• First Posted: September 7, 2005
• Study Start: September 1, 2005
• Primary Completion: September 1, 2009
• Study Completion: September 1, 2009
• Last Updated: August 2, 2013

Record last verified: 2013-08

Locations

CA (1)