Studies of Skin Microbes in Healthy People and in People With Skin Conditions
Studies of Skin Microflora in Healthy Individuals and Atopic Dermatitis Patients
2 other identifiers
observational
530
1 country
1
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 22, 2008
CompletedFirst Submitted
Initial submission to the registry
January 23, 2008
CompletedFirst Posted
Study publicly available on registry
January 31, 2008
CompletedJanuary 16, 2026
December 19, 2025
January 23, 2008
January 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Primary Immunodeficiency
Analyze the microbiome of patients with primary immunodeficiency disorders that are known to have AD-like skin disease.
Ongoing
Healthy volunteers
Characterize the microbiome of healthy individuals.
Ongoing
Study Arms (6)
Grouo 3
Healthy (pediatric) controls
Group 1
Healthy (adult) volunteers
Group 2
AD patients
Group 4
Patients diagnosed with the primary immunodeficiency hyperIgE syndrome (HIES)
Group 5
Patients diagnosed with the primary immunodeficiency Wiskott-Aldrich Syndrome (WAS)
Group 6
Patients diagnosed with the combined immunodeficiency associated with DOCK8 mutation (DOCK8)
Eligibility Criteria
Healthy (adult) volunteers AD patients Healthy (pediatric) controls Patients diagnosed with the primary immunodeficiency hyperIgE syndrome (HIES) Patients diagnosed with the primary immunodeficiency Wiskott-Aldrich Syndrome (WAS) Patients diagnosed with the combined immunodeficiency associated with DOCK8 mutation (DOCK8)
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892, United States
Related Publications (4)
Oh J, Freeman AF; NISC Comparative Sequencing Program; Park M, Sokolic R, Candotti F, Holland SM, Segre JA, Kong HH. The altered landscape of the human skin microbiome in patients with primary immunodeficiencies. Genome Res. 2013 Dec;23(12):2103-14. doi: 10.1101/gr.159467.113. Epub 2013 Oct 29.
PMID: 24170601BACKGROUNDOh J, Byrd AL, Deming C, Conlan S; NISC Comparative Sequencing Program; Kong HH, Segre JA. Biogeography and individuality shape function in the human skin metagenome. Nature. 2014 Oct 2;514(7520):59-64. doi: 10.1038/nature13786.
PMID: 25279917BACKGROUNDGao Z, Tseng CH, Pei Z, Blaser MJ. Molecular analysis of human forearm superficial skin bacterial biota. Proc Natl Acad Sci U S A. 2007 Feb 20;104(8):2927-32. doi: 10.1073/pnas.0607077104. Epub 2007 Feb 9.
PMID: 17293459BACKGROUNDAhmed N, Joglekar P, Deming C; NISC Comparative Sequencing Program; Lemon KP, Kong HH, Segre JA, Conlan S. Genomic characterization of the C. tuberculostearicum species complex, a prominent member of the human skin microbiome. mSystems. 2023 Dec 21;8(6):e0063223. doi: 10.1128/msystems.00632-23. Epub 2023 Nov 10.
PMID: 38126779DERIVED
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Julie A Segre, Ph.D.
National Human Genome Research Institute (NHGRI)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- NIH
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 23, 2008
First Posted
January 31, 2008
Study Start
January 22, 2008
Last Updated
January 16, 2026
Record last verified: 2025-12-19
Data Sharing
- IPD Sharing
- Will not share