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Imiquimod in Children With Plaque Morphea

This study has been completed.
Information provided by (Responsible Party):
Elena Pope, The Hospital for Sick Children Identifier:
First received: September 2, 2005
Last updated: August 1, 2013
Last verified: August 2013
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 Intervention Phase
Scleroderma, Localized
Drug: Imiquimod 5% cream
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:

Further study details as provided by The Hospital for Sick Children:

Primary Outcome Measures:
  • Percent improvement in the thickness of the skin [ Time Frame: 4 weeks, 12 weeks, 24 weeks, 36 weeks, and 48 weeks ]

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

Estimated Enrollment: 10
Study Start Date: September 2005
Study Completion Date: September 2009
Primary Completion Date: September 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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)


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
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Please refer to this study by its identifier: NCT00147771

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

Responsible Party: Elena Pope, Head, Section of Dermatology, The Hospital for Sick Children Identifier: NCT00147771     History of Changes
Other Study ID Numbers: 1000007595
Study First Received: September 2, 2005
Last Updated: August 1, 2013

Keywords provided by The Hospital for Sick Children:
localized scleroderma

Additional relevant MeSH terms:
Scleroderma, Systemic
Scleroderma, Diffuse
Scleroderma, Localized
Connective Tissue Diseases
Skin Diseases
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Antineoplastic Agents
Interferon Inducers processed this record on April 21, 2017