Studies of Skin Microbes in Healthy People and in People With Skin Conditions
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00605878|
Recruitment Status : Recruiting
First Posted : January 31, 2008
Last Update Posted : February 17, 2020
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.
|Condition or disease|
|Atopic Dermatitis Eczema Ichthyosis Vulgaris|
- 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 Type :||Observational|
|Estimated Enrollment :||530 participants|
|Official Title:||Studies of Skin Microflora in Healthy Individuals and Atopic Dermatitis Patients|
|Actual Study Start Date :||January 22, 2008|
Healthy (pediatric) controls
Healthy (adult) volunteers
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)
- Healthy Volunteers [ Time Frame: Ongoing ]Characterize the microbiome of healthy individuals.
- Primary Immunodeficiency [ Time Frame: ongoing ]Analyze the microbiome of patients with primary immunodeficiency disorders that are known to have AD-like skin disease
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00605878
|Contact: Monica Taylor, R.N.||(301) firstname.lastname@example.org|
|Contact: Julie A Segre, Ph.D.||(301) email@example.com|
|United States, Maryland|
|National Institutes of Health Clinical Center, 9000 Rockville Pike||Recruiting|
|Bethesda, Maryland, United States, 20892|
|Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR) 800-411-1222 ext TTY8664111010 firstname.lastname@example.org|
|Principal Investigator:||Julie A Segre, Ph.D.||National Human Genome Research Institute (NHGRI)|