NCT03093805

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2017

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 15, 2017

Completed
8 days until next milestone

First Submitted

Initial submission to the registry

March 23, 2017

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 28, 2017

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 4, 2019

Completed
22 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 26, 2019

Completed
Last Updated

June 12, 2019

Status Verified

June 1, 2019

Enrollment Period

2 years

First QC Date

March 23, 2017

Last Update Submit

June 10, 2019

Conditions

Graft Vs Host Disease

Keywords

Hematopoietic Stem Cell TransplantGraft Versus Host Disease

Outcome Measures

Primary Outcomes (1)

  • GVHD Grade

    Change in GVHD grade over 7 days. GVHD grade based on Glucksberg criteria

    7 days

Study Arms (1)

Calcipotriene

EXPERIMENTAL

Patients will apply Calcipotriene cream 2 times per day for 7 days.

Dietary Supplement: Calcipotriene

Interventions

CalcipotrieneDIETARY_SUPPLEMENT

Topical vitamin D cream will be applied to affected areas of the skin.

Also known as: Dovonex
Calcipotriene

Eligibility Criteria

Age3 Months - 35 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, 45229, United States

Location

MeSH Terms

Conditions

Graft vs Host Disease

Interventions

calcipotriene

Condition Hierarchy (Ancestors)

Immune System Diseases

Study Officials

  • Gregory Wallace, DO

    Children's Hospital Medical Center, Cincinnati

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2017

First Posted

March 28, 2017

Study Start

March 15, 2017

Primary Completion

March 4, 2019

Study Completion

March 26, 2019

Last Updated

June 12, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)