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

Graft Vs Host Disease Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03093805
• Other study ID #: 2016-6739
• Status: Completed
• Phase: N/A
• Start date: March 15, 2017
• Est. completion date: March 26, 2019

Study information

• Verified date: June 2019
• Source: Children's Hospital Medical Center, Cincinnati
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: March 26, 2019
• Est. primary completion date: March 4, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Months to 35 Years

Eligibility

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.

Related Conditions & MeSH terms

• Graft Vs Host Disease

Intervention

Dietary Supplement:
• Calcipotriene
Topical vitamin D cream will be applied to affected areas of the skin.

Locations

Country	Name	City	State
United States	Cincinnati Children's Hospital Medical Center	Cincinnati	Ohio

Sponsors (1)

Lead Sponsor	Collaborator
Children's Hospital Medical Center, Cincinnati

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GVHD Grade	Change in GVHD grade over 7 days. GVHD grade based on Glucksberg criteria	7 days