Molecular Effects of Topical Calcipotriene on Morphea

Overview

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 Type

  • Study Type: Interventional
  • Study Design
    • Allocation: N/A
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Basic Science
    • Masking: None (Open Label)
  • Study Primary Completion Date: April 2016

Interventions

  • Drug: topical calcipotriene 0.005% ointment
    • Affected area will be treated twice daily for 3 months

Arms, Groups and Cohorts

  • Other: topical calcipotriene 0.005% ointment
    • Calcipotriene 0.005% applied to affected areas twice daily to all enrolled subjects

Clinical Trial Outcome Measures

Primary Measures

  • Change of Gene Expression From Skin Biopsy
    • Time Frame: 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 Measures

  • Quality of Life
    • Time Frame: day 0 and 3 months
    • Quality of life questions will be asked at day 0 and 3 months
  • Modified Localized Scleroderma Skin Score
    • Time Frame: 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
    • Time Frame: 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

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Northwestern University
  • Provider of Information About this Clinical Study
    • Principal Investigator: Lauren Graham, Clinical Instructor in Dermatology – Northwestern University

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