Back to resultsAtopic Dermatitis-Like Skin Disease in Pediatric Heart Transplant Patients
Primary Purpose
Dermatitis
Status
Terminated
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Skin Biopsy
Sponsored by
About this trial
This is an interventional trial for Dermatitis focused on measuring Post Pediatric Heart Transplant
Eligibility Criteria
Inclusion Criteria: Patients must have had a heart transplant. Patients must be less than 16 years of age. Exclusion Criteria: Patients who have not had a heart transplant. Patients who are greater than 16 years of age.
Sites / Locations
- University of Minnesota
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00176956
First Posted
September 12, 2005
Last Updated
February 1, 2013
Sponsor
Hordinsky, Maria K., MD
1. Study Identification
Unique Protocol Identification Number
NCT00176956
Brief Title
Atopic Dermatitis-Like Skin Disease in Pediatric Heart Transplant Patients
Official Title
Atopic Dermatitis-Like Skin Disease in Pediatric Heart Transplant Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2013
Overall Recruitment Status
Terminated
Why Stopped
IRB approval has lapsed.
Study Start Date
November 2002 (undefined)
Primary Completion Date
January 2007 (Actual)
Study Completion Date
January 2007 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hordinsky, Maria K., MD
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The skin disease found in pediatric heart transplant patients represents an atopic dermatitis-like rash that is refractory to systemic immunomodulation.
Detailed Description
We want to determine whether pediatric heart transplant patients with an atopic dermatitis-like rash report a personal and/or family history of atopy (asthma, allergies and atopic dermatitis). In addition comparisons will be made between the presence of atopy between patients with and without the skin rash. Comparisons will be made of systemic immunosuppressive therapies between patients with and without the atopic dermatitis-like rash. Determination will be made as to whether histologic characterization of a skin biopsy specimen is consistent with AD. Thorough evaluations will be made of patients in the clinic with this rash and the presence of bacterial superinfection will be ruled out.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis
Keywords
Post Pediatric Heart Transplant
7. Study Design
Study Phase
Phase 3
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Procedure
Intervention Name(s)
Skin Biopsy
Other Intervention Name(s)
Skin biopsy.
Intervention Description
Skin biopsy.
10. Eligibility
Sex
All
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients must have had a heart transplant.
Patients must be less than 16 years of age.
Exclusion Criteria:
Patients who have not had a heart transplant.
Patients who are greater than 16 years of age.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maria Hordinsky, MD
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Minnesota
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Atopic Dermatitis-Like Skin Disease in Pediatric Heart Transplant Patients
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