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Atopic Dermatitis-Like Skin Disease in Pediatric Heart Transplant Patients

This study is currently recruiting participants.
Verified by University of Minnesota, April 2008

Sponsored by: Hordinsky, Maria K., MD
Information provided by: University of Minnesota
ClinicalTrials.gov Identifier: NCT00176956
  Purpose

The skin disease found in pediatric heart transplant patients represents an atopic dermatitis-like rash that is refractory to systemic immunomodulation.


Condition Intervention Phase
Dermatitis
Procedure: Skin Biopsy
Phase III

MedlinePlus related topics:   Heart Transplantation    Skin Conditions   

U.S. FDA Resources

Study Type:   Observational
Study Design:   Cohort, Cross-Sectional
Official Title:   Atopic Dermatitis-Like Skin Disease in Pediatric Heart Transplant Patients

Further study details as provided by University of Minnesota:

Biospecimen Retention:   Samples With DNA

Biospecimen Description:

Tissue


Estimated Enrollment:   30
Study Start Date:   November 2002
Estimated Study Completion Date:   November 2010

Intervention Details:
    Procedure: Skin Biopsy
    Skin biopsy.
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.

  Eligibility
Ages Eligible for Study:   up to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample

Study Population

Patients with a heart transplant and atopic dermatitis like skin.


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.
  Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00176956

Contacts
Contact: Maria Hordinsky, MD     612-625-1493     hordi001@umn.edu    

Locations
United States, Minnesota
University of Minnesota     Recruiting
      Minneapolis, Minnesota, United States, 55455
      Contact: Maria Hordinsky, MD     612-625-1493     hordi001@umn.edu    
      Principal Investigator: Maria Hordinsky, MD            

Sponsors and Collaborators
Hordinsky, Maria K., MD

Investigators
Principal Investigator:     Maria Hordinsky, MD     University of Minnesota    
  More Information


Responsible Party:   University of Minnesota ( Maria Hordinsky, MD )
Study ID Numbers:   0110M09983
First Received:   September 12, 2005
Last Updated:   April 25, 2008
ClinicalTrials.gov Identifier:   NCT00176956
Health Authority:   United States: Institutional Review Board

Keywords provided by University of Minnesota:
Post Pediatric Heart Transplant  

Study placed in the following topic categories:
Hypersensitivity
Dermatitis, Atopic
Genetic Diseases, Inborn
Skin Diseases
Hypersensitivity, Immediate
Skin Diseases, Eczematous
Skin Diseases, Genetic
Dermatitis

Additional relevant MeSH terms:
Immune System Diseases

ClinicalTrials.gov processed this record on October 23, 2008




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