Imiquimod in Children With Plaque Morphea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Elena Pope, The Hospital for Sick Children
ClinicalTrials.gov Identifier:
NCT00147771
First received: September 2, 2005
Last updated: August 1, 2013
Last verified: August 2013
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Frequency of side-effects [ Time Frame: 48 weeks ] [ Designated as safety issue: No ]

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)

  Eligibility

Ages Eligible for Study:   6 Years to 18 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00147771

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

No publications provided

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

Keywords provided by The Hospital for Sick Children:
localized scleroderma
morphea
imiquimod
pediatrics

Additional relevant MeSH terms:
Scleroderma, Systemic
Scleroderma, Diffuse
Scleroderma, Localized
Connective Tissue Diseases
Skin Diseases
Imiquimod
Adjuvants, Immunologic
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antineoplastic Agents
Therapeutic Uses
Interferon Inducers

ClinicalTrials.gov processed this record on July 29, 2014