Studies of Skin Microflora in Healthy Individuals and Atopic Dermatitis Patients

Status: Recruiting
Location: See location...
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 2
Maximum Age: 100
Healthy Volunteers: t
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• 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.

Locations
United States
Maryland
National Institutes of Health Clinical Center
RECRUITING
Bethesda
Contact Information
Primary
Monica E Taylor, R.N.
monica.taylor@nih.gov
(301) 451-2221
Backup
Julie A Segre, Ph.D.
js608m@nih.gov
(301) 402-2314
Time Frame
Start Date: 2008-01-22
Participants
Target number of participants: 530
Treatments
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)
Authors
Julia A Segre
Related Therapeutic Areas
Sponsors
Leads: National Human Genome Research Institute (NHGRI)

This content was sourced from clinicaltrials.gov

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