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Natural History of Atopic Dermatitis and Other Genetic/Congenital Diseases Associated With Allergic Inflammation

This study is currently Recruiting

January 2011 By National Institutes of Health Clinical Center (CC)

First Recieved on July 15, 2010

Last Updated on March 25, 2011

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by: National Institutes of Health Clinical Center (CC)
Identifier: NCT01164241


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 sample...

Study Type: Observational
Study Design: Time Perspective: Prospective


Ages Eligible for Study:1 Month
Genders Eligible for Study:Both
Accepts Healthy Volunteers:No

- INCLUSION CRITERIA: 1. Subject or unaffected relatives must: 1. Be at least 1 month of age and less than or equal to 21 years of age at the time of enrollment and have documented history of AD, by modified Hanifin and Rajka criteria, that began in the first 5 years of life, that is moderate to severe, and with continued active flares in the preceding 3 months. Patients greater than 21 years of age with active moderate to severe AD may be enrolled, at the discretion of the PI or AIs, if they have a history of AD in the first 5 years of life or, if in the opinion of the PI or AIs, the patient would be of interest to fulfill the objectives of the study. OR 2. Be one month- 80 years of age with a suspected genetic or congenital disorder associated with atopy or affecting an atopic pathway, as determined by the PI or AIs. OR 3. Be an unaffected relative of a patient enrolled in the protocol. 2. Have a private physician to provide local continuity of care. 3. Provide a letter of referral, with copies of pertinent medical history and laboratory studies as indicated, from prospective study participant's referring physician; this is not a requirement for healthy relatives. 4. Be willing to donate blood, stool, buccal swabs, saliva, skin and nasal swabs for research and clinical studies and for storage to be used for future research; for unaffected relatives, be willing to donate blood and/or undergo allergy skin testing, in addition to having blood samples stored for future research. Healthy Volunteer must: 1. Be at least 18 years old and no greater than 80 years old. 2. Have no history of recent, active atopic dermatitis, allergies, or asthma. 3. Be willing to have samples stored for research and genetic testing. EXCLUSION CRITERIA: Any subject with any of the following criteria will be excluded: 1. Presence of conditions that, in the judgment of the investigator or the referring physician, may put the subject at undue risk or make them unsuitable for participation in the study. 2. Inability or refusal to undergo study procedures. 3. Inability to participate for the duration of the study. Any unaffected relative or healthy volunteer with any of the following criteria will be excluded: 1. Presence of conditions that, in the judgment of the investigator or the referring physician, may put the subject at undue risk or make them unsuitable for participation in the study. 2. Inability or refusal to undergo study procedures.



  • National Institutes of Health Clinical Center, 9000 Rockville Pike

    Bethesda, Maryland 20892 United States

Conditions related to this trial:

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