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Natural History of Severe Allergic Inflammation and Reactions

NCT01164241 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 945

Last updated 2026-05-20

No results posted yet for this study

Summary

Background:

\- Allergic inflammation is central to allergy-related diseases and disorders, such as asthma, food allergies, and atopic dermatitis. Atopic dermatitis, commonly called eczema is a chronic, noncontagious skin condition, usually starting in the first years of life, which causes itching and scaling of an individual s skin. Because atopic dermatitis is a common condition in children who have allergy-related diseases, including asthma, researchers are interested in studying both individuals with atopic dermatitis and their close relatives (parents and children) to better understand how allergy-related diseases develop and progress. In addition, some patients with inherited disorders with features including atopic dermatitis or other aspects of allergy such as food allergy, asthma, hay fever, hives, and others, will also be seen.

Objectives:

\- To study the natural history of diseases of allergic inflammation, such as atopic dermatitis or genetic disorders associated with allergic inflammation.

Eligibility:

* Children and adolescents between 1 month and 21 years of age who have a documented history of moderate to severe atopic dermatitis.
* Individuals between 1 month and 80 years of age who have a suspected genetic or inherited allergy disorder related to atopic dermatitis or allergic pathways.
* Child and adult relatives of eligible participants will also be studied on this protocol.

Design:

* The study will require one initial visit to the National Institutes of Health Clinical Center (lasting 1-5 days), as well as any required follow-up visits for treatment and research studies. Participants will receive treatment for atopic dermatitis and other allergic diseases as part of the study for up to 1 year.
* Participants will have some or all of the following tests as part of this study:
* A detailed physical examination and medical history
* Allergy skin prick testing to examine participants' responses to different allergens.
* Blood samples for additional allergen testing, testing the immune system, and other research purposes
* Skin punch biopsy to take a skin sample
* Lung function tests to measure airflow from the lungs and inflammation
* Food-related tests to diagnose potential food allergies
* Leukapheresis to collect white blood cells only
* Research samples, including stool specimens, saliva samples, buccal swabs (to collect cells from the inside of the cheek), and skin cell samples
* Clinical digital photography to provide images of affected and healthy skin.
* Participants will be asked to return for follow-up visits and tests for up to 1 year after the initial visit(s).

Conditions

  • PGM3 Deficiency
  • Eosinophilic and/or Atopic Dermatitis
  • OSMR Deficiency
  • Primary Localized Cutaneous Amyloidosis
  • Hereditary Alpha-tryptasemia

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Pamela A Guerrerio, M.D. · National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility

Min Age
2 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-07-12

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01164241 on ClinicalTrials.gov