Topical Vitamin D in Acute Graft Versus Host Disease of the Skin

Clinical Effectiveness of Calcipotriene in Acute Graft Versus Host Disease of the Skin: A Pilot Study

The purpose of this study is to evaluate the efficacy of Calcipotriene cream. This is a synthetic vitamin D3 derivative for topical use. It is used to treat grade 1-3 acute skin graft versus host disease (GVHD) in hematopoietic stem cell transplant (HSCT) recipients. Calcipotriene will be used as the exclusive topical therapy in addition to standard of care GVHD treatment prescribed for the study subject by the primary physician.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

Acute skin GVHD affects about one third of pediatric and adult transplant recipients. Chronic GVHD (cGVHD) affects 40-60% of adult patients who have undergone allogeneic HSCT. It is a major cause of non-relapse mortality and morbidity. Systemic prednisone is the first-line treatment for cGVHD; however, about one-half of all patients do not respond to this initial therapy, and there is no standard second-line therapy. Immunosuppressive therapy used for treatment of GVHD brings significant risk of infection, poorly affecting clinical outcomes.

Vitamin D affects immunoregulation, fibroblast proliferation, collagen synthesis and endothelial cell function, and the investigators hypothesize that topical vitamin D application will have a positive effect on acute and chronic skin GVHD. The investigators hypothesize that topical vitamin D cream may restore normal cell function and decrease the use of steroid creams in acute GVHD of the skin.

Study Type

Interventional

Enrollment (Actual)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

3 months to 35 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • HSCT recipients with acute Grade I through III GVHD based on Glucksberg criteria. Recipients of multiple transplants are still eligible to participate in this research study.
  • Each study subject is to have calcium and vitamin D level prior to starting study, if not obtained within 30 days of beginning treatment.

Exclusion Criteria:

  • Patient with active cellulitis at the start of the treatment.
  • Patients with hypercalcemia or vitamin D levels above 100 μg/L.
  • Patients with known allergy to any of the topical therapy components.
  • Patients who have received previous treatment with topical vitamin D cream.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Calcipotriene
Patients will apply Calcipotriene cream 2 times per day for 7 days.
Topical vitamin D cream will be applied to affected areas of the skin.
Other Names:
  • Dovonex

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GVHD Grade
Time Frame: 7 days
Change in GVHD grade over 7 days. GVHD grade based on Glucksberg criteria
7 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Gregory Wallace, DO, Children's Hospital Medical Center, Cincinnati

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 15, 2017

Primary Completion (Actual)

March 4, 2019

Study Completion (Actual)

March 26, 2019

Study Registration Dates

First Submitted

March 23, 2017

First Submitted That Met QC Criteria

March 23, 2017

First Posted (Actual)

March 28, 2017

Study Record Updates

Last Update Posted (Actual)

June 12, 2019

Last Update Submitted That Met QC Criteria

June 10, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Graft Vs Host Disease

Clinical Trials on Calcipotriene

3
Subscribe