Comparative Effectiveness Trial in the Treatment of Pediatric Plaque Morphea
Primary Purpose
Scleroderma
Status
Withdrawn
Phase
Phase 1
Locations
Study Type
Interventional
Intervention
Clobetasol
Calcipotriene
Tacrolimus
Sponsored by
About this trial
This is an interventional treatment trial for Scleroderma
Eligibility Criteria
Inclusion Criteria:
- presence of at least 1 active lesion of morphea on the neck, trunk, or extremities with no prior treatment to that lesion for at least 4 weeks
Exclusion Criteria:
- children receiving phototherapy or systemic therapy for their morphea
- children with linear or generalized morphea
- lesions on the face
- greater than 3% body surface area involvement
- open or ulcerated skin within morphea lesions
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Active Comparator
Arm Label
Treatment 1
Treatment 2
Treatment 3
Arm Description
Calcipotriene 0.005% ointment
Clobetasol 0.05% ointment
Tacrolimus 0.1% ointment
Outcomes
Primary Outcome Measures
Visual Analog Scale
This is a 100 mm scale with 3 anchors; each 5 mm of the scale is equivalent to 10% change.
Visual Analog Scale
This is a 100 mm scale with 3 anchors; each 5 mm of the scale is equivalent to 10% change.
Secondary Outcome Measures
Full Information
NCT ID
NCT02680717
First Posted
February 9, 2016
Last Updated
July 17, 2018
Sponsor
Medical College of Wisconsin
Collaborators
Mayo Clinic, Seattle Children's Hospital, University of Toronto
1. Study Identification
Unique Protocol Identification Number
NCT02680717
Brief Title
Comparative Effectiveness Trial in the Treatment of Pediatric Plaque Morphea
Official Title
Comparative Effectiveness Trial of Topical Calcipotriene, Clobetasol, and Tacrolimus in the Treatment of Pediatric Plaque Morphea
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Unable to obtain IRB approval at all sites
Study Start Date
March 2016 (undefined)
Primary Completion Date
May 2017 (Anticipated)
Study Completion Date
May 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medical College of Wisconsin
Collaborators
Mayo Clinic, Seattle Children's Hospital, University of Toronto
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a study designed to evaluate the comparative effectiveness of topical medications for the treatment of circumscribed morphea.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Scleroderma
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment 1
Arm Type
Active Comparator
Arm Description
Calcipotriene 0.005% ointment
Arm Title
Treatment 2
Arm Type
Active Comparator
Arm Description
Clobetasol 0.05% ointment
Arm Title
Treatment 3
Arm Type
Active Comparator
Arm Description
Tacrolimus 0.1% ointment
Intervention Type
Drug
Intervention Name(s)
Clobetasol
Intervention Description
ointment, twice daily (alternating weeks)
Intervention Type
Drug
Intervention Name(s)
Calcipotriene
Intervention Description
ointment, twice daily
Intervention Type
Drug
Intervention Name(s)
Tacrolimus
Intervention Description
ointment, 0.1%, twice daily
Primary Outcome Measure Information:
Title
Visual Analog Scale
Description
This is a 100 mm scale with 3 anchors; each 5 mm of the scale is equivalent to 10% change.
Time Frame
2 months
Title
Visual Analog Scale
Description
This is a 100 mm scale with 3 anchors; each 5 mm of the scale is equivalent to 10% change.
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
presence of at least 1 active lesion of morphea on the neck, trunk, or extremities with no prior treatment to that lesion for at least 4 weeks
Exclusion Criteria:
children receiving phototherapy or systemic therapy for their morphea
children with linear or generalized morphea
lesions on the face
greater than 3% body surface area involvement
open or ulcerated skin within morphea lesions
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yvonne Chiu, MD
Organizational Affiliation
Medical College of Wisconsin
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Comparative Effectiveness Trial in the Treatment of Pediatric Plaque Morphea
We'll reach out to this number within 24 hrs