- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00176956
Atopic Dermatitis-Like Skin Disease in Pediatric Heart Transplant Patients
February 1, 2013 updated by: Hordinsky, Maria K., MD
The skin disease found in pediatric heart transplant patients represents an atopic dermatitis-like rash that is refractory to systemic immunomodulation.
Study Overview
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
Enrollment (Anticipated)
30
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Minnesota
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Minneapolis, Minnesota, United States, 55455
- University Of Minnesota
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
No older than 16 years (CHILD)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2002
Primary Completion (ACTUAL)
January 1, 2007
Study Completion (ACTUAL)
January 1, 2007
Study Registration Dates
First Submitted
September 12, 2005
First Submitted That Met QC Criteria
September 12, 2005
First Posted (ESTIMATE)
September 15, 2005
Study Record Updates
Last Update Posted (ESTIMATE)
February 5, 2013
Last Update Submitted That Met QC Criteria
February 1, 2013
Last Verified
February 1, 2013
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0110M09983
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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