RecruitingNCT00605878

Studies of Skin Microbes in Healthy People and in People With Skin Conditions

Studies of Skin Microflora in Healthy Individuals and Atopic Dermatitis Patients

Sponsor

National Human Genome Research Institute (NHGRI)

Enrollment

530 participants

Start Date

Jan 22, 2008

Study Type

OBSERVATIONAL

Conditions

Atopic Dermatitis Eczema

Summary

This study will examine microbes (e.g., bacteria, fungi, viruses) that live on human skin and how microbes contribute to health and disease. It will analyze healthy human skin and how the these microorganisms might change in patients with atopic dermatitis (AD), a skin condition also known as eczema. Healthy volunteers, as well as patients with moderate to severe eczema (AD), between 2 and 40 years of age may be eligible for this study. We also wish to enroll children and adults aged 2-40 who have been diagnosed with inherited immune disorders known as HIES (hyperimmunoglobulin-E syndrome), WAS (Wiskott-Aldrich syndrome), or DOCK8 immunodeficiency because they frequently have skin problems similar to AD. Eligible participants undergo the following tests and procedures: * Medical family and medication history * Skin examination * Blood tests (research blood as well as serum IgE, and complete blood count) * Skin samples to analyze microbes. Samples are obtained by the following methods: swabbing the skin with a cotton swab; scraping (scratching) the skin gently with a blade to remove only the outermost skin layers; and, only in adults, biopsy (surgical removal) of a small skin sample less than 1/4-inch (5 mm) in diameter. * Nose swabs to analyze microbes. * Patients with eczema may have photographs of their skin taken to help monitor the skin rashes. Participants may be contacted periodically for follow-up studies. Patients with atopic dermatitis may have additional skin samples collected to examine changes in the skin bacteria over time and during all of the stages of eczema. In addition, patients who have a flare of their eczema are asked to undergo a skin sample collection as soon as possible.

Eligibility

Min Age: 2 YearsMax Age: 100 Years

Inclusion Criteria7

Must have a primary care professional who will continue standard of care/evaluation in tandem with the protocol to whom information and recommendations can be communicated.
Adult males or females aged 18-50 at time of enrollment.
A. Confirmed diagnosis of AD (UK Working Party s Diagnostic Criteria)24
B. Moderate to severe AD SCORAD greater than or equal to 25(25)
C. Greater than or equal to 1 affected antecubital (or popliteal) fossae at time of enrollment to serve as a target site.
A. Males or females 2-18 years of age.
A. Must have mutation-proven diagnosis, with or without eczematous dermatitis.

Exclusion Criteria12

Any subjects receiving or planning to receive an IND agent, ultraviolet light therapy, monoclonal antibodies, or systemic immunosuppressants \< 7 days or 5 half-lives (whichever is the longer time period) of initiating this protocol.
Any subjects who have cancer, and are currently or have previously received treatment with chemotherapy or radiation for treatment of malignancies within the previous 6 months.
Any subject with a history of bone marrow transplant or gene therapy.
A. Unable to remain off systemic (oral) antibiotics or systemic (oral) steroids for at least 7 days prior to body site sampling. 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/emollients for AD may be continued to non-adjacent, nontarget sites.)
B. Underlying immunodeficiency, either as primary disease or secondary to treatment.
A. Unable to remain off topical steroids and emollients for preferably 7 days but at least 24 hours prior to body site sampling.
A. Any subjects with unstable or uncontrolled or chronic medical conditions requiring treatment or hospitalization. Individual determinations will be made at the discretion of the medical investigator.
B. Underlying immunodeficiency, either as primary disease or secondary to treatment.
C. Other documented chronic dermatologic disease, such as AD or psoriasis that may interfere with evaluation of the cutaneous microbiome. Common transient conditions, such as acne, are permissible.
D. Subjects who provide direct healthcare or reside in healthcare facilities or in non-hospital settings such as assisted living facilities, homeless shelters, jails and prisons as well as subjects with frequent exposure to laboratory animals.
E. Subjects with asthma.
\. Any female with symptoms and/or serum hormone levels consistent with perimenopause