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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT00176956
Other study ID # 0110M09983
Secondary ID
Status Terminated
Phase Phase 3
First received September 12, 2005
Last updated February 1, 2013
Start date November 2002
Est. completion date January 2007

Study information

Verified date February 2013
Source University of Minnesota - Clinical and Translational Science Institute
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial Summary

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


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.


Recruitment information / eligibility

Status Terminated
Enrollment 30
Est. completion date January 2007
Est. primary completion date January 2007
Accepts healthy volunteers No
Gender Both
Age group N/A to 16 Years
Eligibility 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.

Study Design

N/A


Related Conditions & MeSH terms


Intervention

Procedure:
Skin Biopsy
Skin biopsy.

Locations

Country Name City State
United States University of Minnesota Minneapolis Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Hordinsky, Maria K., MD

Country where clinical trial is conducted

United States, 

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