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Molecular Effects of Topical Calcipotriene on Morphea

Primary Purpose

Morphea, Localized Scleroderma

Status
Terminated
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
topical calcipotriene 0.005% ointment
Sponsored by
Northwestern University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Morphea

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Sites / Locations

  • Northwestern University Feinberg School of Medicine, Department of Dermatology

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

topical calcipotriene 0.005% ointment

Arm Description

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Quality of Life
Quality of life questions will be asked at day 0 and 3 months
Modified Localized Scleroderma Skin Score
The firmness or tightness of the skin will be measured throughout the body at day 0 and 3 months
Change of Appearance of Skin Biopsy
Skin biopsy will be taken at baseline and 3 months, skin will be examined for expression levels of different proteins

Full Information

First Posted
March 3, 2015
Last Updated
December 22, 2017
Sponsor
Northwestern University
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1. Study Identification

Unique Protocol Identification Number
NCT02411643
Brief Title
Molecular Effects of Topical Calcipotriene on Morphea
Official Title
Molecular Effects of Topical Calcipotriene on Morphea
Study Type
Interventional

2. Study Status

Record Verification Date
December 2017
Overall Recruitment Status
Terminated
Why Stopped
Accrual incomplete/Investigator left institution
Study Start Date
March 2015 (undefined)
Primary Completion Date
April 2016 (Actual)
Study Completion Date
April 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northwestern University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Morphea, Localized Scleroderma

7. Study Design

Primary Purpose
Basic Science
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)

8. Arms, Groups, and Interventions

Arm Title
topical calcipotriene 0.005% ointment
Arm Type
Other
Arm Description
Calcipotriene 0.005% applied to affected areas twice daily to all enrolled subjects
Intervention Type
Drug
Intervention Name(s)
topical calcipotriene 0.005% ointment
Other Intervention Name(s)
Dovonex
Intervention Description
Affected area will be treated twice daily for 3 months
Primary Outcome Measure Information:
Title
Change of Gene Expression From Skin Biopsy
Description
Skin biopsy will be taken at day 0 and 3 months, RNA will be looked at for different gene expression levels
Time Frame
day 0 and 3 months
Secondary Outcome Measure Information:
Title
Quality of Life
Description
Quality of life questions will be asked at day 0 and 3 months
Time Frame
day 0 and 3 months
Title
Modified Localized Scleroderma Skin Score
Description
The firmness or tightness of the skin will be measured throughout the body at day 0 and 3 months
Time Frame
day 0 and 3 months
Title
Change of Appearance of Skin Biopsy
Description
Skin biopsy will be taken at baseline and 3 months, skin will be examined for expression levels of different proteins
Time Frame
day 0 and 3 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Facility Information:
Facility Name
Northwestern University Feinberg School of Medicine, Department of Dermatology
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States

12. IPD Sharing Statement

Learn more about this trial

Molecular Effects of Topical Calcipotriene on Morphea

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