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Atopic Dermatitis-Like Skin Disease in Pediatric Heart Transplant Patients

This study has been terminated.
(IRB approval has lapsed.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT00176956
First Posted: September 15, 2005
Last Update Posted: February 5, 2013
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.
Information provided by (Responsible Party):
University of Minnesota - Clinical and Translational Science Institute ( Hordinsky, Maria K., MD )
  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 3

Study Type: Interventional
Official Title: Atopic Dermatitis-Like Skin Disease in Pediatric Heart Transplant Patients

Resource links provided by NLM:


Further study details as provided by University of Minnesota - Clinical and Translational Science Institute ( Hordinsky, Maria K., MD ):

Estimated Enrollment: 30
Study Start Date: November 2002
Study Completion Date: January 2007
Primary Completion Date: January 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Procedure: Skin Biopsy
    Skin biopsy.
    Other Name: 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

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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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): NCT00176956


Locations
United States, Minnesota
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Sponsors and Collaborators
Hordinsky, Maria K., MD
Investigators
Principal Investigator: Maria Hordinsky, MD University of Minnesota - Clinical and Translational Science Institute
  More Information

Responsible Party: Hordinsky, Maria K., MD
ClinicalTrials.gov Identifier: NCT00176956     History of Changes
Other Study ID Numbers: 0110M09983
First Submitted: September 12, 2005
First Posted: September 15, 2005
Last Update Posted: February 5, 2013
Last Verified: February 2013

Keywords provided by University of Minnesota - Clinical and Translational Science Institute ( Hordinsky, Maria K., MD ):
Post Pediatric Heart Transplant

Additional relevant MeSH terms:
Dermatitis
Dermatitis, Atopic
Eczema
Skin Diseases
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases