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Imiquimod in Children With Plaque Morphea

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00147771
Recruitment Status : Completed
First Posted : September 7, 2005
Last Update Posted : August 2, 2013
Information provided by (Responsible Party):
Elena Pope, The Hospital for Sick Children

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.

Condition or disease Intervention/treatment Phase
Scleroderma, Localized Drug: Imiquimod 5% cream Phase 3

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)

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : September 2005
Actual Primary Completion Date : September 2009
Actual Study Completion Date : September 2009

Arm Intervention/treatment
Experimental: 1 Drug: Imiquimod 5% cream
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 Measures :
  1. Percent improvement in the thickness of the skin [ Time Frame: 4 weeks, 12 weeks, 24 weeks, 36 weeks, and 48 weeks ]

Secondary Outcome Measures :
  1. Frequency of side-effects [ Time Frame: 48 weeks ]

Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00147771

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Canada, Ontario
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1X8
Sponsors and Collaborators
The Hospital for Sick Children
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Principal Investigator: Elena Pope, MD The Hospital for Sick Children

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Responsible Party: Elena Pope, Head, Section of Dermatology, The Hospital for Sick Children Identifier: NCT00147771    
Other Study ID Numbers: 1000007595
First Posted: September 7, 2005    Key Record Dates
Last Update Posted: August 2, 2013
Last Verified: August 2013
Keywords provided by Elena Pope, The Hospital for Sick Children:
localized scleroderma
Additional relevant MeSH terms:
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Scleroderma, Systemic
Scleroderma, Diffuse
Scleroderma, Localized
Connective Tissue Diseases
Skin Diseases
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Interferon Inducers