Atopic Dermatitis-Like Skin Disease in Pediatric Heart Transplant Patients

This study has been suspended.

(IRB approval has lapsed.)

Sponsor:

Information provided by:

University of Minnesota - Clinical and Translational Science Institute

ClinicalTrials.gov Identifier:

NCT00176956

First received: September 12, 2005

Last updated: March 5, 2010

Last verified: March 2010

History of Changes

Tracking Information

First Received Date ^ICMJE

September 12, 2005

Last Updated Date

March 5, 2010

Start Date ^ICMJE

November 2002

Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00176956 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Current Other Outcome Measures ^ICMJE

Original Other Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Atopic Dermatitis-Like Skin Disease in Pediatric Heart Transplant Patients

Official Title ^ICMJE

Atopic Dermatitis-Like Skin Disease in Pediatric Heart Transplant Patients

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.

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Condition ^ICMJE

Dermatitis

Intervention ^ICMJE

Procedure: Skin Biopsy

Skin biopsy.

Other Name: Skin biopsy.

Study Arm (s)

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Suspended

Estimated Enrollment ^ICMJE

Estimated Completion Date

April 2009

Primary Completion Date

April 2009 (final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Gender

Both

Ages

up to 16 Years

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT Number ^ICMJE

NCT00176956

Other Study ID Numbers ^ICMJE

0110M09983

Has Data Monitoring Committee

Responsible Party

Maria Hordinsky, MD, University of Minnesota

Study Sponsor ^ICMJE

Hordinsky, Maria K., MD

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator:

Maria Hordinsky, MD

University of Minnesota - Clinical and Translational Science Institute

Information Provided By

University of Minnesota - Clinical and Translational Science Institute

Verification Date

March 2010

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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