Molecular Effects of Topical Calcipotriene on Morphea

Study Overview
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Brief Summary
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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.

Official Title
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Molecular Effects of Topical Calcipotriene on Morphea

Conditions
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Morphea, Localized Scleroderma

Intervention / Treatment
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* Drug: topical calcipotriene 0.005% ointment


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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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 |