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

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ClinicalTrials.gov Identifier: NCT03093805
Recruitment Status : Completed
First Posted : March 28, 2017
Last Update Posted : June 12, 2019
Sponsor:
Information provided by (Responsible Party):
Children's Hospital Medical Center, Cincinnati

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.

Condition or disease Intervention/treatment Phase
Graft Vs Host Disease Dietary Supplement: Calcipotriene Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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


Arm Intervention/treatment
Experimental: Calcipotriene
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




Primary Outcome Measures :
  1. GVHD Grade [ Time Frame: 7 days ]
    Change in GVHD grade over 7 days. GVHD grade based on Glucksberg criteria



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Ages Eligible for Study:   3 Months to 35 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

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


Locations
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United States, Ohio
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States, 45229
Sponsors and Collaborators
Children's Hospital Medical Center, Cincinnati
Investigators
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Principal Investigator: Gregory Wallace, DO Children's Hospital Medical Center, Cincinnati

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Responsible Party: Children's Hospital Medical Center, Cincinnati
ClinicalTrials.gov Identifier: NCT03093805     History of Changes
Other Study ID Numbers: 2016-6739
First Posted: March 28, 2017    Key Record Dates
Last Update Posted: June 12, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Children's Hospital Medical Center, Cincinnati:
Hematopoietic Stem Cell Transplant
Graft Versus Host Disease
Additional relevant MeSH terms:
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Graft vs Host Disease
Immune System Diseases
Calcitriol
Calcipotriene
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Dermatologic Agents
Calcium-Regulating Hormones and Agents
Calcium Channel Agonists
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Vasoconstrictor Agents