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

Launched by NATIONAL HUMAN GENOME RESEARCH INSTITUTE (NHGRI) · Jan 26, 2008

Keywords

ClinConnect Summary

This clinical trial is investigating the tiny living organisms, like bacteria and fungi, that naturally exist on our skin and how they might affect our health, especially in people with skin conditions like eczema (also known as atopic dermatitis). The researchers want to understand how the skin microbes of healthy individuals differ from those of people dealing with moderate to severe eczema. The study is open to healthy volunteers and patients aged 2 to 40 who have eczema or certain inherited immune disorders that can cause similar skin issues.

If you or a family member decides to participate, you can expect to undergo a series of tests. These include providing a medical history, a skin examination, blood tests, and skin samples collected through gentle swabbing or scraping. In some cases, a small piece of skin may be taken for further study. The goal is to analyze how skin microbes change in response to eczema over time, especially during flare-ups. Participants will also be asked to keep in touch for follow-up studies. It’s important to note that there are specific eligibility criteria, so potential participants should discuss with their doctor to see if they qualify for the study.

Gender

ALL

Eligibility criteria

• * INCLUSION CRITERIA:
• • Inclusion Criteria for all groups
• • 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.
• • Inclusion Criteria for Group 1: Healthy Volunteers
• • Adult males or females aged 18-50 at time of enrollment.
• • Inclusion Criteria for Group 2: AD patients
• • 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.
• • Inclusion Criteria for Group 3: Healthy (pediatric) Controls
• • A. Males or females 2-18 years of age.
• • Inclusion Criteria for Groups 4, 5, \& 6: AD/HIES/WAS/DOCK8 patients
• • A. Must have mutation-proven diagnosis, with or without eczematous dermatitis.
• EXCLUSION CRITERIA:
• Exclusion Criteria for all groups:
• • 1. 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.
• • 2. 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.
• • 3. Any subject with a history of bone marrow transplant or gene therapy.
• • Exclusion Criteria specific for Group 2: AD patients
• • 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.
• Exclusion Criteria specific for Groups 4, 5, \& 6: HIES/WAS/DOCK8 patients:
• • A. Unable to remain off topical steroids and emollients for preferably 7 days but at least 24 hours prior to body site sampling.
• Exclusion Criteria specific for Groups 1 \& 3: Healthy Volunteers and Healthy (pediatric) Controls:
• • 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.
• • 5. Any female with symptoms and/or serum hormone levels consistent with perimenopause