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Clinical Trial 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.


Clinical Trial 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) ;


Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT00147771
Study type Interventional
Source The Hospital for Sick Children
Contact
Status Completed
Phase Phase 3
Start date September 2005
Completion date September 2009

See also
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Recruiting NCT01808937 - Morphea in Adults and Children (MAC) Cohort Study: A Morphea Registry and DNA Repository
Completed NCT00479934 - Efficacy and Safety of Imatinib in Scleroderma Phase 2
Terminated NCT03740724 - A Study of FCX-013 Plus Veledimex for the Treatment of Moderate to Severe Localized Scleroderma (Morphea) Phase 1/Phase 2
Completed NCT00129428 - Ultraviolet B (UVB) Light Therapy in the Treatment of Skin Conditions With Altered Dermal Matrix Phase 1/Phase 2