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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Withdrawn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
Medical College of Wisconsin
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Scleroderma

Eligibility Criteria

2 Years - 18 Years (Child, Adult)All SexesDoes not accept healthy volunteers

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

    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
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    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    Withdrawn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

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