Topical Vitamin D in Acute Graft Versus Host Disease of the Skin
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT03093805|
Recruitment Status : Completed
First Posted : March 28, 2017
Last Update Posted : June 12, 2019
|Condition or disease||Intervention/treatment||Phase|
|Graft Vs Host Disease||Dietary Supplement: Calcipotriene||Not Applicable|
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 (Clinical Trial)|
|Actual Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Clinical Effectiveness of Calcipotriene in Acute Graft Versus Host Disease of the Skin: A Pilot Study|
|Actual Study Start Date :||March 15, 2017|
|Actual Primary Completion Date :||March 4, 2019|
|Actual Study Completion Date :||March 26, 2019|
Patients will apply Calcipotriene cream 2 times per day for 7 days.
Dietary Supplement: Calcipotriene
Topical vitamin D cream will be applied to affected areas of the skin.
Other Name: Dovonex
- GVHD Grade [ Time Frame: 7 days ]Change in GVHD grade over 7 days. GVHD grade based on Glucksberg criteria
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03093805
|United States, Ohio|
|Cincinnati Children's Hospital Medical Center|
|Cincinnati, Ohio, United States, 45229|
|Principal Investigator:||Gregory Wallace, DO||Children's Hospital Medical Center, Cincinnati|