INCLUSION CRITERIA FOR AD PATIENTS:
1. Males or females 3 - 40 years of age. Minimum age of 3 enriches for patients that have active AD and are statistically less likely to resolve during this longitudinal study. Maximum age of 40 is to reduce chance of recruiting patients with age-related changes in skin.
2. Diagnosis of atopic dermatitis on the basis of the criteria defined by UK Working Party's Diagnostic Criteria for Atopic Dermatitis.
3. SCORAD (SCORing Atopic Dermatitis) score of greater than or equal to 25 indicating AD severity of moderate to severe.
4. At least one antecubital (or popliteal) fossae must be affected at the time of enrollment to serve as a target site.
5. Must have a primary care professional who will continue care/evaluation in tandem with the protocol and to whom information can be communicated.
EXCLUSION CRITERIA FOR AD PATIENTS:
1. Subjects with unstable or uncontrolled medical conditions that could require hospitalization during the course of the study or who have been hospitalized in the last month.
2. Subjects receiving or planning to receive an IND agent, ultraviolet light therapy, monoclonal antibodies, or systemic immunosuppressants less than 7 days or 5 half-lives (whichever is the longer time period) of initiating this protocol.
3. Subjects who are unable to remain off systemic (oral) antibiotics or systemic (oral) steroids for at least 7 days prior to skin sample collection.
4. Subjects who are unable to temporarily discontinue use of topical steroids or calcineurin inhibitors for greater than or equal to 7 days to small areas of skin intended for sampling. (Topical therapies for AD may be continued to non-adjacent, non-target sites.)
5. Subjects with underlying immunodeficiency, either as primary disease or secondary to treatment.
6. Subjects who are currently or have previously received treatment with chemotherapy or radiation for treatment of malignancies.
7. Subject with a chronic disease requiring treatment; e.g. diabetes, bone marrow transplant, hepatitis.
INCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:
1. Males or females 3 - 40 years of age.
2. Must have matched age range (i.e. toddler, child, pre-pubertal, pubertal, adult) and intervals of visits to enrolled AD patients.
EXCLUSION CRITERIA FOR HEALTHY VOLUNTEERS:
1. Subjects with unstable or uncontrolled medical conditions that could require hospitalization during the course of the study or who have been hospitalized in the last month.
2. Subjects receiving or planning to receive an IND agent, ultraviolet light therapy, monoclonal antibodies, or systemic immunosuppressants less than 7 days or 5 half-lives (whichever is the longer time period) of initiating this protocol.
3. Subjects who are unable to remain off systemic (oral) antibiotics or systemic (oral) steroids for at least 7 days.
4. Subjects with underlying immunodeficiency, either as primary disease or secondary to treatment.
5. Subjects who are currently or have previously received treatment with chemotherapy or radiation.
6. Subject with a chronic disease requiring treatment; e.g. diabetes, bone marrow transplant, hepatitis.
7. Subject with a history of chronic sinusitis, asthma or allergic airway hyperresponsiveness.
8. Subject with severe food allergies and/or contact allergies. Mild responses will be documented in the medical record.
9. Subject with other documented chronic dermatologic disease, such as AD or psoriasis, that may interfere with evaluation of cutaneous microbiome. Common transient conditions, such as acne, are permissible.
10. Subjects who work or reside in healthcare facilities or in non-hopsital settings that provide healthcare such as assisted living facilities, homeless shelters, jails and prisons as well as subjects with frequent exposure to laboratory animals, in order to minimize potential ascertainment bias.
National Institutes of Health Clinical Center
Bethesda, Maryland 20892. Last update: 09/16/2008