Studies of Skin Microbes in Healthy People and in People With Skin Conditions
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|ClinicalTrials.gov Identifier: NCT00605878|
Recruitment Status : Recruiting
First Posted : January 31, 2008
Last Update Posted : March 30, 2023
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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)
- Primary Immunodeficiency [ Time Frame: Ongoing ]Analyze the microbiome of patients with primary immunodeficiency disorders that are known to have AD-like skin disease.
- Healthy volunteers [ Time Frame: Ongoing ]Characterize the microbiome of healthy individuals.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
|Ages Eligible for Study:||2 Years and older (Child, Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||Yes|
|Sampling Method:||Non-Probability Sample|
- 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 for all groups:
- Any subjects receiving or planning to receive an IND agent, ultraviolet light therapy, monoclonal antibodies, or systemic immunosuppressants < 7 days or 5 half-lives (whichever is the longer time period) of initiating this protocol.
- Any subjects who have cancer, and are currently or have previously received treatment with chemotherapy or radiation for treatment of malignancies within the previous 6 months.
- 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) steroids 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
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) email@example.com|
|Contact: Julie A Segre, Ph.D.||(301) firstname.lastname@example.org|
|United States, Maryland|
|National Institutes of Health Clinical Center||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 TTY dial 711 email@example.com|
|Principal Investigator:||Julie A Segre, Ph.D.||National Human Genome Research Institute (NHGRI)|
|Responsible Party:||National Human Genome Research Institute (NHGRI)|
|Other Study ID Numbers:||
|First Posted:||January 31, 2008 Key Record Dates|
|Last Update Posted:||March 30, 2023|
|Last Verified:||January 31, 2023|
|Studies a U.S. FDA-regulated Drug Product:||No|
|Studies a U.S. FDA-regulated Device Product:||No|
Atopic Dermatitis (Eczema)
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases, Eczematous
Immune System Diseases
Infant, Newborn, Diseases