Clinical Trial: Comparative Effectiveness Trial in the Treatment of Pediatric Plaque Morphea
Study Status: Withdrawn
Recruit Status: Withdrawn
Study Type: Interventional
Official Title: Comparative Effectiveness Trial of Topical Calcipotriene, Clobetasol, and Tacrolimus in the Treatment of Pediatric Plaque Morphea
Brief Summary: This is a study designed to evaluate the comparative effectiveness of topical medications for the treatment of circumscribed morphea.
Detailed Summary:
Morphea, also known as localized scleroderma, is a rare autoimmune fibrosing disorder that affects children and adults. Morphea causes significant morbidity through atrophy and fibrosis of the skin and underlying structures. Treatment can halt the progression of disease but cannot reverse disease damage, leaving children with disfiguring scars and sometimes functional impairment. Consequently, it is of extreme importance to intervene early in the disease course with effective therapies to limit morbidity.
Circumscribed morphea is the second most common subtype in children, comprising approximately 1/3 of pediatric morphea cases. It is a disfiguring disease that can cause pain and pruritus. There are no FDA-approved treatments and no consensus exists on the ideal therapy for circumscribed morphea, either in adults or children. Most physicians use topical medications for circumscribed morphea yet there is little evidence to support these therapies. Topical immune modulators such as tacrolimus, imiquimod, and calcipotriene have been investigated in small studies, though these trials were limited by very small sample sizes of 9-19 patients and lack of a control in most. Surveys have demonstrated that topical steroids are the most commonly prescribed medication, even though the only evidence to support their use comes from case reports. With insufficient evidence regarding topical therapies, providers have no guidance when making treatment decisions, practice patterns vary widely even amongst pediatric dermatologists, and children continue with preventable scars.
The investigators specific aim is to identify effective topical therapy for circumscribed morphea. The investigators will utilize a comparative cohort study design to evaluate the comparative effectiveness of three topical medications: clobetasol ointment, calcipotrien
Sponsor: Medical College of Wisconsin
Current Primary Outcome:
- Visual Analog Scale [ Time Frame: 2 months ]This is a 100 mm scale with 3 anchors; each 5 mm of the scale is equivalent to 10% change.
- Visual Analog Scale [ Time Frame: 4 months ]This is a 100 mm scale with 3 anchors; each 5 mm of the scale is equivalent to 10% change.
Original Primary Outcome: Same as current
Current Secondary Outcome:
Original Secondary Outcome:
Information By: Medical College of Wisconsin
Dates:
Date Received: February 9, 2016
Date Started: March 2016
Date Completion: May 2017
Last Updated: September 15, 2016
Last Verified: September 2016
