ClinicalTrials.gg
RecruitingNCT00605878Updated Nov 5, 2026

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

An observational study in Eczema and Atopic Dermatitis, sponsored by National Human Genome Research Institute (NHGRI). Recruiting at 1 site in United States. Open to participants aged 2 Years to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-05.

Sponsored by National Human Genome Research Institute (NHGRI) · Observational

From the registry’s dates

  • Started Jan 2008; still recruiting 18 years 9 months later.
Updated Oct 29, 2026Study contact changedGo to Updates ↓
Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
530
Ages
2 Years to 100 Years
Sex
All
01

Study 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.

Read the detailed description
  • Skin microbiota (bacteria, fungi, viruses, phage, archae) play a significant role in common dermatological conditions, such as atopic dermatitis/AD (eczema).
  • Since culture-dependent methods are often biased assessments of microbial diversity, genomic methods can expand our understanding of the human microbiome and skin diseases.
  • Chronic dermatitis is typical among rare primary immunodeficiencies: Wiskott-Aldrich syndrome; hyper-IgE syndrome; and combined immunodeficiency associated with DOCK8 mutation syndrome. The skin disease in these monogenic disorders resembles AD, is associated with microbial infections, and may provide additional insight into microbial-host disease interactions.
02

Conditions studied

  • Eczema
  • Atopic Dermatitis

Keywords

  • Skin
  • Natural History
  • Microbiome
  • Bacteria
  • Atopic Dermatitis (Eczema)
  • Atopic Dermatitis
  • Eczema
  • Health Volunteer
  • HG
03

In context

Eczema

503 studies on the registry are indexed under Eczema; 89 are open to participants now.

This study's planned enrollment of 530 is above the median of 300 across 81 observational studies indexed under Eczema.

Browse Eczema studies →

Lead sponsor

National Human Genome Research Institute (NHGRI) is the lead sponsor of 203 studies on the registry; 33 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study population

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)

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 \< 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 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) 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

Terms in these criteria, in plain language(3)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

Corticosteroids (steroids)

Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.

Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.

05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
530 participants (estimated)

Groups and cohorts

  • 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)

06

What researchers measure

Primary outcomes

  1. Primary Immunodeficiency

    Analyze the microbiome of patients with primary immunodeficiency disorders that are known to have AD-like skin disease.

    Time frame: Ongoing

  2. Healthy volunteers

    Characterize the microbiome of healthy individuals.

    Time frame: Ongoing

07

Study locations

1 of 1 sites recruiting
  • National Institutes of Health Clinical Center
    Bethesda, Maryland 20892, United States
    Recruiting
    • For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) · Contactccopr@nih.gov · 800-411-1222
08

References and documents

Publications

  • 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. PubMed 24170601 ↗
  • Oh 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. PubMed 25279917 ↗
  • Gao 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. PubMed 17293459 ↗
  • Ahmed 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. PubMed 38126779 ↗

Individual participant data

Plan to share: No

09

Timeline

5 registry updates since Sep 25, 2026

Started Jan 2008 (actual).

How these figures are worked out, and which studies are left out of them.

Registered
Jan 23, 2008
First posted
Jan 31, 2008
StartActual
Jan 22, 2008
Last update
Nov 5, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Contact
Study contact changed: removed j•••@nih.gov · •••2314. See the current contact
Oct 29, 2026
Show all 5 updates
  1. Nov 5, 2026
    Minor edits only
    + 1 other change: description
  2. Nov 3, 2026
    Minor edits only
    + 1 other change: description
  3. Oct 29, 2026
    Contact Study contact changed: removed j•••@nih.gov · •••2314. See the current contact
  4. Oct 13, 2026
    Minor edits only
    + 1 other change: description
  5. Oct 8, 2026
    Minor edits only
    + 1 other change: description

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT00605878
Responsible party
Sponsor
First posted
Jan 31, 2008
Start date
Jan 22, 2008
Last update
Nov 5, 2026

Study contacts

Heidi H Kong, M.D.
Contact
niamsderm@nih.gov
(301) 827-2460
Heidi H Kong, M.D.
principal investigator · National Human Genome Research Institute (NHGRI)

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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