Molecular Effects of Topical Calcipotriene on Morphea

Morphea Clinical Trial

Official title:

Molecular Effects of Topical Calcipotriene on Morphea

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02411643
• Other study ID #: STU00101294
• Status: Terminated
• Phase: Early Phase 1
• Start date: March 2015
• Est. completion date: April 2016

Study information

• Verified date: December 2017
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: April 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Localized Scleroderma
• Morphea
• Scleroderma, Localized

Intervention

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

Locations

Country	Name	City	State
United States	Northwestern University Feinberg School of Medicine, Department of Dermatology	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Quality of Life	Quality of life questions will be asked at day 0 and 3 months	day 0 and 3 months
Secondary	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
Secondary	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