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

NCT ID: NCT03093805

Last Updated: 2019-06-12

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-03-15
• Study Completion Date: 2019-03-26

Brief Summary

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.

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.

Conditions

Graft Vs Host Disease

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Calcipotriene

Patients will apply Calcipotriene cream 2 times per day for 7 days.

Group Type: EXPERIMENTAL

Calcipotriene

Intervention Type: DIETARY_SUPPLEMENT

Topical vitamin D cream will be applied to affected areas of the skin.

Interventions

Calcipotriene

Topical vitamin D cream will be applied to affected areas of the skin.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Dovonex

Eligibility Criteria

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.

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 35 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Children's Hospital Medical Center, Cincinnati

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Gregory Wallace, DO

Role: PRINCIPAL_INVESTIGATOR

Children's Hospital Medical Center, Cincinnati

Locations

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Countries

United States

Other Identifiers

2016-6739

Identifier Type: -

Identifier Source: org_study_id