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

Recruiting

• Conditions: Atopic Dermatitis; Eczema

• Registration Number: NCT00605878
• Lead Sponsor: National Human Genome Research Institute (NHGRI)

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.

Study Timeline

• Study Start: 2008-01-22
• Study First Submitted: 2008-01-23
• Study First Submitted QC: 2008-01-26
• Study First Posted: 2008-01-31
• Status Verified: 2024-10-07
• Last Update Submitted: 2025-03-21
• Last Update Posted: 2025-03-24

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 530

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Healthy volunteers	Ongoing	Characterize the microbiome of healthy individuals.
Primary Immunodeficiency	Ongoing	Analyze the microbiome of patients with primary immunodeficiency disorders that are known to have AD-like skin disease.

Trial Locations

Locations (1)

National Institutes of Health Clinical Center; 🇺🇸 Bethesda, Maryland, United States