Natural History of Severe Allergic Inflammation and Reactions
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|ClinicalTrials.gov Identifier: NCT01164241|
Recruitment Status : Recruiting
First Posted : July 16, 2010
Last Update Posted : October 5, 2021
- 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.
- To study the natural history of diseases of allergic inflammation, such as atopic dermatitis or genetic disorders associated with allergic inflammation.
- 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.
- 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).
|Condition or disease|
|PGM3 Deficiency Eosinophilic and/or Atopic Dermatitis OSMR Deficiency Primary Localized Cutaneous Amyloidosis Hereditary Alpha-tryptasemia|
|Study Type :||Observational|
|Estimated Enrollment :||2150 participants|
|Official Title:||Natural History of Severe Allergic Inflammation and Reactions|
|Actual Study Start Date :||July 12, 2010|
other allergic phenotypes
- SCORAD [ Time Frame: At initial and single follow up visit 1-2 months after. ]Severity of atopic dermatitis, only taken when present.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01164241
|Contact: Judith Bandoh||(301) email@example.com|
|Contact: Jonathan J Lyons, M.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 email@example.com|
|Principal Investigator:||Jonathan J Lyons, M.D.||National Institute of Allergy and Infectious Diseases (NIAID)|