Molecular Effects of Topical Calcipotriene on Morphea

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.

Study Overview

• Status: Terminated
• Conditions: Morphea; Localized Scleroderma
• Intervention / Treatment: Drug: topical calcipotriene 0.005% ointment

• Study Type: Interventional
• Enrollment (Actual): 2
• Phase: Early Phase 1

Contacts and Locations

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University Feinberg School of Medicine, Department of Dermatology

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: topical calcipotriene 0.005% ointment; Calcipotriene 0.005% applied to affected areas twice daily to all enrolled subjects	Drug: topical calcipotriene 0.005% ointment; Affected area will be treated twice daily for 3 months; Other Names: Dovonex

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Quality of Life	Quality of life questions will be asked at day 0 and 3 months	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	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	day 0 and 3 months

Collaborators and Investigators

• Sponsor: Northwestern University

Study record dates

Study Major Dates

• Study Start: March 1, 2015
• Primary Completion (Actual): April 1, 2016
• Study Completion (Actual): April 1, 2016

Study Registration Dates

• First Submitted: March 3, 2015
• First Submitted That Met QC Criteria: April 2, 2015
• First Posted (Estimate): April 8, 2015

Study Record Updates

• Last Update Posted (Actual): September 13, 2018
• Last Update Submitted That Met QC Criteria: December 22, 2017
• Last Verified: December 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Connective Tissue Diseases; Scleroderma, Localized; Dermatologic Agents; Calcipotriene
• Other Study ID Numbers: STU00101294

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No