Graft Vs Host Disease
Conditions
Keywords
Hematopoietic Stem Cell Transplant, Graft Versus Host Disease
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.
Interventions
DIETARY_SUPPLEMENTCalcipotriene
Topical vitamin D cream will be applied to affected areas of the skin.
Sponsors
Children's Hospital Medical Center, Cincinnati
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
3 Months to 35 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| GVHD Grade | 7 days | Change in GVHD grade over 7 days. GVHD grade based on Glucksberg criteria |
Countries
United States
Outcome results
None listed