NCT02411643

Brief Summary

This study will look into how topical treatment with synthetic Vitamin D3, calcipotriene ointment, used as standard of care, works in patients with morphea. Skin biopsies of morphea lesions before and after treatment with topical calcipotriene 0.005% ointment will be analyzed for changes in RNA and protein. A skin biopsy of unaffected skin will also be obtained and used for a control. This is an initial study to look at the molecular effects of topical calcipotriene on human morphea-involved skin. This study will look at the differences between affected and unaffected skin. This study also will look at clinical outcomes in morphea patients and determine if there are any clinical predictors for improvement with the medication.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
2

participants targeted

Target at below P25 for early_phase_1

Timeline
Completed

Started Mar 2015

Shorter than P25 for early_phase_1

Geographic Reach
1 country

1 active site

Status
terminated

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

Study Start

First participant enrolled

March 1, 2015

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

March 3, 2015

Completed
1 month until next milestone

First Posted

Study publicly available on registry

April 8, 2015

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2016

Completed
2.5 years until next milestone

Results Posted

Study results publicly available

September 13, 2018

Completed
Last Updated

September 13, 2018

Status Verified

December 1, 2017

Enrollment Period

1.1 years

First QC Date

March 3, 2015

Results QC Date

December 22, 2017

Last Update Submit

December 22, 2017

Conditions

MorpheaLocalized Scleroderma

Outcome Measures

Primary Outcomes (1)

  • Change of Gene Expression From Skin Biopsy

    Skin biopsy will be taken at day 0 and 3 months, RNA will be looked at for different gene expression levels

    day 0 and 3 months

Secondary Outcomes (3)

  • Quality of Life

    day 0 and 3 months

  • Modified Localized Scleroderma Skin Score

    day 0 and 3 months

  • Change of Appearance of Skin Biopsy

    day 0 and 3 months

Study Arms (1)

topical calcipotriene 0.005% ointment

OTHER

Calcipotriene 0.005% applied to affected areas twice daily to all enrolled subjects

Drug: topical calcipotriene 0.005% ointment

Interventions

topical calcipotriene 0.005% ointmentDRUG

Affected area will be treated twice daily for 3 months

Also known as: Dovonex
topical calcipotriene 0.005% ointment

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Subjects with clinically-diagnosed or biopsy proven plaque-type, guttate, linear, segmental, and generalized morphea that are receiving calcipotriene 0.005% ointment as part of their standard of care treatment will be included.
  • Subjects are allowed to have previously been on any therapy as long as they have been off systemic treatment, topical therapy or phototherapy for 4 weeks prior to baseline.
  • Age ≥ 18 years.
  • Ability to understand and the willingness to sign a written informed consent.

You may not qualify if:

  • Subjects with the diagnosis of morphea profundus, eosinophilic fasciitis, and atrophoderma will be excluded.
  • Subjects who are receiving oral or topical immunosuppression therapy or phototherapy within 4 weeks prior to entering the study.
  • Subjects may not be receiving any investigational agents.
  • Subjects must not be pregnant or nursing.
  • Patients allergic to lidocaine or epinephrine or who have a history of impaired wound healing or for any reason are unable to undergo a skin biopsy.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northwestern University Feinberg School of Medicine, Department of Dermatology

Chicago, Illinois, 60611, United States

Location

MeSH Terms

Conditions

Scleroderma, Localized

Interventions

calcipotrieneOintments

Condition Hierarchy (Ancestors)

Connective Tissue DiseasesSkin and Connective Tissue DiseasesSkin Diseases

Intervention Hierarchy (Ancestors)

Dosage FormsPharmaceutical Preparations

Results Point of Contact

Title
Stephanie Rangel
Organization
Northwestern University
stephanie.rangel@northwestern.edu
3125035942

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
early phase 1
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Instructor in Dermatology

Study Record Dates

First Submitted

March 3, 2015

First Posted

April 8, 2015

Study Start

March 1, 2015

Primary Completion

April 1, 2016

Study Completion

April 1, 2016

Last Updated

September 13, 2018

Results First Posted

September 13, 2018

Record last verified: 2017-12

Locations

US(1)