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

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.

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.