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Protocol Details

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

This study is currently recruiting participants.

Summary | Eligibility | Citations | Contacts

Summary

Number

10-I-0148

Sponsoring Institute

National Institute of Allergy and Infectious Diseases (NIAID)

Recruitment Detail

Type: Participants currently recruited/enrolled
Gender: Male & Female
Min Age: 2
Max Age: 80

Referral Letter Required

Yes

Population Exclusion(s)

None

Special Instructions

Currently Not Provided

Keywords

CARD14;
Tryptase;
CARD11;
Genetics;
Atopy

Recruitment Keyword(s)

None

Condition(s)

PLAID;
Atopic Dermatitis;
CARD11;
CARD14;
Hereditary Alpha Trytasemia

Investigational Drug(s)

None

Investigational Device(s)

None

Intervention(s)

None

Supporting Site

National Institute of Allergy and Infectious Diseases

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).

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Eligibility

INCLUSION CRITERIA:

1. Subject or unaffected relatives must:

a. 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

b. 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

c. 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.

5.Pregnant women or women who become pregnant are eligible to participate or continue participation on the study.

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.


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Citations:

Not Provided

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Contacts:

Principal Investigator

Referral Contact

For more information:

Joshua D. Milner, M.D.
National Institute of Allergy and Infectious Diseases (NIAID)
BG 10 RM 11N240A
10 CENTER DR
BETHESDA MD 20814
(301) 827-3662
jdmilner@mail.nih.gov

Thomas H. Dimaggio, R.N.
National Institute of Allergy and Infectious Diseases (NIAID)
National Institutes of Health
Building 10
Room 6-3750
10 Center Drive
Bethesda, Maryland 20892
(301) 443-8341
dimaggiot@mail.nih.gov

Office of Patient Recruitment
National Institutes of Health Clinical Center (CC)
Building 61, 10 Cloister Court
Bethesda, Maryland 20892
Toll Free: 1-800-411-1222
Local Phone: 301-451-4383
TTY: 1-866-411-1010
PRPL@cc.nih.gov

Clinical Trials Number:

NCT01164241

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