Clinical Trial: Molecular Effects of Topical Calcipotriene on Morphea

Study Status: Terminated
Recruit Status: Terminated
Study Type: Interventional

Official Title: Molecular Effects of Topical Calcipotriene on Morphea

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 Summary:
Sponsor: Northwestern University

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • 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


Original Secondary Outcome: Same as current

Information By: Northwestern University

Dates:
Date Received: March 3, 2015
Date Started: March 2015
Date Completion:
Last Updated: May 2, 2016
Last Verified: May 2016