Molecular Effects of Topical Calcipotriene on Morphea

Early Phase 1

Terminated

• Conditions: Morphea; Localized Scleroderma
• Interventions: Drug: topical calcipotriene 0.005% ointment

• Registration Number: NCT02411643
• Lead Sponsor: Northwestern University

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-03
• Study First Submitted: 2015-03-03
• Study First Submitted QC: 2015-04-02
• Study First Posted: 2015-04-08
• Primary Completion: 2016-04
• Study Completion: 2016-04
• Status Verified: 2017-12
• Results First Submitted: 2017-12-22
• Results First Submitted QC: 2017-12-22
• Last Update Submitted: 2017-12-22
• Results First Posted: 2018-09-13
• Last Update Posted: 2018-09-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 2

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.

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
topical calcipotriene 0.005% ointment	topical calcipotriene 0.005% ointment	Calcipotriene 0.005% applied to affected areas twice daily to all enrolled subjects

Primary Outcome Measures

Name	Time	Method
Change of Gene Expression From Skin Biopsy	day 0 and 3 months	Skin biopsy will be taken at day 0 and 3 months, RNA will be looked at for different gene expression levels

Secondary Outcome Measures

Name	Time	Method
Quality of Life	day 0 and 3 months	Quality of life questions will be asked at day 0 and 3 months
Modified Localized Scleroderma Skin Score	day 0 and 3 months	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	day 0 and 3 months	Skin biopsy will be taken at baseline and 3 months, skin will be examined for expression levels of different proteins

Trial Locations

Locations (1)

Northwestern University Feinberg School of Medicine, Department of Dermatology; 🇺🇸 Chicago, Illinois, United States