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Atopic Dermatitis-Like Skin Disease in Pediatric Heart Transplant Patients

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

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

Condition or disease Intervention/treatment Phase
Dermatitis Procedure: Skin Biopsy Phase 3

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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Official Title: Atopic Dermatitis-Like Skin Disease in Pediatric Heart Transplant Patients
Study Start Date : November 2002
Primary Completion Date : January 2007
Study Completion Date : January 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources


Intervention Details:
    Procedure: Skin Biopsy
    Skin biopsy.
    Other Name: Skin biopsy.



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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.

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

Responsible Party: Hordinsky, Maria K., MD
ClinicalTrials.gov Identifier: NCT00176956     History of Changes
Other Study ID Numbers: 0110M09983
First Posted: September 15, 2005    Key Record Dates
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