Examining skin microbes in healthy individuals and those with eczema
Studies of Skin Microflora in Healthy Individuals and Atopic Dermatitis Patients
This study looks at the tiny germs on the skin of healthy people and those with eczema to see how they differ and what that might mean for skin health.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 530 (estimated) |
| Ages | 2 Years to 100 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT00605878 on ClinicalTrials.gov |
What this trial studies
This observational study investigates the role of skin microbes, including bacteria, fungi, and viruses, in both healthy individuals and those suffering from atopic dermatitis (eczema). It aims to analyze how the skin microbiome differs between healthy skin and skin affected by eczema, as well as in patients with specific inherited immune disorders that present similar skin issues. Participants aged 2 to 40, including healthy volunteers and patients with moderate to severe eczema, will undergo skin examinations, blood tests, and skin sample collection for microbial analysis. The study utilizes advanced genomic methods to gain a deeper understanding of microbial diversity and its implications for skin health.
Who should consider this trial
Good fit: Ideal candidates include healthy individuals aged 2-40 and patients with moderate to severe atopic dermatitis or specific inherited immune disorders.
Not a fit: Patients with skin conditions unrelated to atopic dermatitis or those outside the specified age range may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved understanding and management of eczema and related skin conditions.
How similar studies have performed: Previous studies have shown promising results in understanding the skin microbiome's role in dermatological conditions, suggesting this approach could yield valuable insights.
Eligibility criteria
Show full inclusion / exclusion 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. EXCLUSION CRITERIA: Exclusion Criteria for all groups: 1. 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. 2. 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. 3. 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
Where this trial is running
Bethesda, Maryland
- National Institutes of Health Clinical Center — Bethesda, Maryland, United States (Recruiting)
Study contacts
- Principal investigator: Julie A Segre, Ph.D. — National Human Genome Research Institute (NHGRI)
- Study coordinator: Heidi H Kong, M.D.
- Email: niamsderm@nih.gov
- Phone: (301) 827-2460
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.