Atopic Dermatitis-Like Skin Disease in Pediatric Heart Transplant Patients

Dermatitis Clinical Trial

Official title:

Atopic Dermatitis-Like Skin Disease in Pediatric Heart Transplant Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00176956
• Other study ID #: 0110M09983
• 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

• Dermatitis
• Dermatitis, Atopic
• Eczema
• Skin Diseases

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,