NCT02680717

Brief Summary

This is a study designed to evaluate the comparative effectiveness of topical medications for the treatment of circumscribed morphea.

Trial Health

15
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Timeline
Completed

Started Mar 2016

Status
withdrawn

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 9, 2016

Completed
2 days until next milestone

First Posted

Study publicly available on registry

February 11, 2016

Completed
19 days until next milestone

Study Start

First participant enrolled

March 1, 2016

Completed
1.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

July 18, 2018

Status Verified

July 1, 2018

Enrollment Period

1.2 years

First QC Date

February 9, 2016

Last Update Submit

July 17, 2018

Conditions

Scleroderma

Outcome Measures

Primary Outcomes (2)

  • Visual Analog Scale

    This is a 100 mm scale with 3 anchors; each 5 mm of the scale is equivalent to 10% change.

    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.

    4 months

Study Arms (3)

Treatment 1

ACTIVE COMPARATOR

Calcipotriene 0.005% ointment

Drug: Calcipotriene

Treatment 2

ACTIVE COMPARATOR

Clobetasol 0.05% ointment

Drug: Clobetasol

Treatment 3

ACTIVE COMPARATOR

Tacrolimus 0.1% ointment

Drug: Tacrolimus

Interventions

ClobetasolDRUG

ointment, twice daily (alternating weeks)

Treatment 2
CalcipotrieneDRUG

ointment, twice daily

Treatment 1
TacrolimusDRUG

ointment, 0.1%, twice daily

Treatment 3

Eligibility Criteria

Age2 Years - 18 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Scleroderma, Diffuse

Interventions

ClobetasolcalcipotrieneTacrolimus

Condition Hierarchy (Ancestors)

Scleroderma, SystemicConnective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Intervention Hierarchy (Ancestors)

BetamethasoneSteroids, FluorinatedSteroidsFused-Ring CompoundsPolycyclic CompoundsMacrolidesLactonesOrganic Chemicals

Study Officials

  • Yvonne Chiu, MD

    Medical College of Wisconsin

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 9, 2016

First Posted

February 11, 2016

Study Start

March 1, 2016

Primary Completion

May 1, 2017

Study Completion

May 1, 2017

Last Updated

July 18, 2018

Record last verified: 2018-07