A Phase 1 interventional study of Clobetasol and Calcipotriene in Scleroderma, sponsored by Medical College of Wisconsin. Withdrawn. Open to participants aged 2 Years to 18 Years. Per ClinicalTrials.gov, last updated 2018-07-18.
Sponsored by Medical College of Wisconsin · Phase 1, Interventional, and Treatment
This is a study designed to evaluate the comparative effectiveness of topical medications for the treatment of circumscribed morphea.
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, calcipotriene ointment, and tacrolimus 0.1% ointment. The investigators will enroll subjects at CHW and other institutions to achieve the study enrollment necessary to power this study.
115 studies on the registry are indexed under Scleroderma, Localized; 16 are open to participants now.
Browse Scleroderma, Localized studies →Medical College of Wisconsin is the lead sponsor of 540 studies on the registry; 120 are open to participants now.
Of its 71 completed or terminated interventional studies of FDA-regulated products, 56 (79%) have results posted.
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Exclusion Criteria:
Calcipotriene 0.005% ointment
Drug: Calcipotriene
Clobetasol 0.05% ointment
Drug: Clobetasol
Tacrolimus 0.1% ointment
Drug: Tacrolimus
ointment, twice daily (alternating weeks)
ointment, twice daily
ointment, 0.1%, twice daily
Visual Analog Scale
This is a 100 mm scale with 3 anchors; each 5 mm of the scale is equivalent to 10% change.
Time frame: 2 months
Visual Analog Scale
This is a 100 mm scale with 3 anchors; each 5 mm of the scale is equivalent to 10% change.
Time frame: 4 months
No study locations are listed for this record.
This study is withdrawn, as verified in Jul 2018. You cannot join it, but the record below documents what was studied.
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Medical College of Wisconsin