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Imiquimod in Children With Plaque Morphea

Primary Purpose

Scleroderma, Localized

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Imiquimod 5% cream
Sponsored by
The Hospital for Sick Children
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scleroderma, Localized focused on measuring localized scleroderma, morphea, imiquimod, pediatrics

Eligibility Criteria

6 Years - 18 Years (Child, Adult)All SexesDoes not accept 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

Sites / Locations

  • The Hospital for Sick Children

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

Outcomes

Primary Outcome Measures

Percent improvement in the thickness of the skin

Secondary Outcome Measures

Frequency of side-effects

Full Information

First Posted
September 2, 2005
Last Updated
August 1, 2013
Sponsor
The Hospital for Sick Children
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1. Study Identification

Unique Protocol Identification Number
NCT00147771
Brief Title
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

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
September 2005 (undefined)
Primary Completion Date
September 2009 (Actual)
Study Completion Date
September 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
The Hospital for Sick Children

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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)

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scleroderma, Localized
Keywords
localized scleroderma, morphea, imiquimod, pediatrics

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Imiquimod 5% cream
Intervention Description
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.
Primary Outcome Measure Information:
Title
Percent improvement in the thickness of the skin
Time Frame
4 weeks, 12 weeks, 24 weeks, 36 weeks, and 48 weeks
Secondary Outcome Measure Information:
Title
Frequency of side-effects
Time Frame
48 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Elena Pope, MD
Organizational Affiliation
The Hospital for Sick Children
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Hospital for Sick Children
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 1X8
Country
Canada

12. IPD Sharing Statement

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Imiquimod in Children With Plaque Morphea

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