Status:

COMPLETED

Registry for the Atopic Dermatitis Research Network

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Collaborating Sponsors:

Atopic Dermatitis Research Network

Conditions:

Atopic Dermatitis

Eczema Herpeticum

Eligibility:

All Genders

8-80 years

Brief Summary

The purpose of this multi-center, clinical registry study is to determine genetic markers associated with susceptibility of AD patients to infections and to also serve as a potential participant datab...

Detailed Description

People with atopic dermatitis (AD), also known as eczema, experience hot, dry, scaly skin with severe itching. In addition, people with AD are prone to skin infections and inflammation. Little is know...

Eligibility Criteria

Inclusion

  • Participants who meet all of the following criteria are eligible for enrollment. Participants may be reassessed if not initially eligible.
  • ADEH+ and Non-atopic males and females ages 8 months to 80 years, inclusive, at the time of Enrollment, and ADEH- males and females ages 3 years to 80 years, inclusive, at the time of Enrollment.
  • Who are willing to sign the informed consent form or whose parent or legal guardian is willing to sign the informed consent form (age appropriate) prior to initiation of any study procedures.
  • Who are willing to sign the assent form, if age appropriate.
  • Who meet criteria for one of the diagnostic groups (ADEH-Staph+, ADEH-Staph-, ADEH+, ADEV+, Non-atopic) as defined in the ADRN Standard Diagnostic Criteria and the Staphylococcus aureus Colonization Criteria.

Exclusion

  • Participants who meet any of the following criteria are not eligible for enrollment.
  • Who have an active systemic malignancy; uncomplicated non-melanoma skin cancer and melanoma in situ with documentation of complete excision are not exclusionary.
  • Who have any skin disease other than AD that might compromise the stratum corneum barrier (e.g., bullous diseases, psoriasis, cutaneous T cell lymphoma \[also called Mycosis Fungoides or Sezary syndrome\], dermatitis herpetiformis, Hailey-Hailey, or Darier's disease).
  • Who have a history of systemic immunological illness (e.g., immunodeficiency disorders such as human immunodeficiency virus \[HIV\] or lupus erythematosus) other than the condition being studied.
  • Who have a first degree relative already enrolled in the study.
  • Who are determined not to be eligible in the opinion of the Investigator.

Key Trial Info

Start Date :

August 1 2011

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

February 7 2018

Estimated Enrollment :

3387 Patients enrolled

Trial Details

Trial ID

NCT01494142

Start Date

August 1 2011

End Date

February 7 2018

Last Update

September 19 2018

Active Locations (9)

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Page 1 of 3 (9 locations)

1

Children's Hospital Los Angeles

Los Angeles, California, United States, 90027

2

National Jewish Health

Denver, Colorado, United States, 80206

3

Northwestern University

Chicago, Illinois, United States, 60611

4

Ann & Robert H. Lurie Children's Hospital of Chicago

Chicago, Illinois, United States, 60614