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Clinical Trial Details for Natural History of Diseases Associated With Allergic Inflammation: Atopic Dermatitis and Genetic and Congenital Diseases Associated With Atopic Pathways


National Institute of Allergy and Infectious Diseases (NIAID)
NCT ID: NCT01164241
Last Updated: January 29, 2019

The Study at a Glance

  • Status: Recruiting
  • Phase:
  • Gender: All
  • Age: 2 Years - 80 Years
  • Condition: Atopic Dermatitis
  • Study Type: Observational
  • Intervention:
  • Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
  • Location: Not Provided

Official Title

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

Purpose

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).

Eligibility

Ages Eligible for Study

2 Years to 80 Years

Sexes Eligible for Study

All

Accepts Healthy Volunteers

Accepts Healthy Volunteers

Criteria

– INCLUSION CRITERIA:

1. Subject or unaffected relatives must:

1. Be at least 2 years 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 and/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 2-80 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, 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, moderate to severe atopic dermatitis.

3. Be willing to have samples stored for research and genetic testing.

4. For a subset of subjects participating in the cooling cuff procedure, be willing to
have research skin biopsies performed.

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.

Additional Information, Locations & Contacts

Sponsors & Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Investigators

Principal Investigator: Kelly D Stone, M.D.

National Institute of Allergy and Infectious Diseases (NIAID)

Please refer to this study by its ClinicalTrials.gov identifier: NCT01164241

Location

Contacts

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland 20892

United States

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

prpl@cc.nih.gov