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

Studies of Skin Microflora in Healthy Individuals and Atopic Dermatitis Patients

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT00605878
Enrollment
530
Registered
2008-01-31
Start date
2008-01-22
Completion date
Unknown
Last updated
2026-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis, Eczema

Keywords

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

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.

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.

Interventions

None listed

Sponsors

National Human Genome Research Institute (NHGRI)
Lead SponsorNIH

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
2 Years to 100 Years
Healthy volunteers
Yes

Inclusion 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.

Design outcomes

Primary

MeasureTime frameDescription
Primary ImmunodeficiencyOngoingAnalyze the microbiome of patients with primary immunodeficiency disorders that are known to have AD-like skin disease.
Healthy volunteersOngoingCharacterize the microbiome of healthy individuals.

Countries

United States

Contacts

CONTACTHeidi H Kong, M.D.
niamsderm@nih.gov(301) 827-2460
CONTACTJulie A Segre, Ph.D.
js608m@nih.gov(301) 402-2314
PRINCIPAL_INVESTIGATORJulie A Segre, Ph.D.

National Human Genome Research Institute (NHGRI)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Sep 17, 2026