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

  • STATUS
    Recruiting
  • participants needed
    530
  • sponsor
    National Human Genome Research Institute (NHGRI)
Updated on 27 August 2021
skin disorder
blood test
atopy
serum ige
eczema
immune disorder
rash
examination skin

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.

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.

Details
Condition Eczema, Ichthyosis, Ichthyosis Vulgaris, ATOPIC DERMATITIS, Dermatitis, Eczema (Atopic Dermatitis), Dermatitis, Atopic, Hand Dermatitis, Eczema (Atopic Dermatitis - Pediatric), Eczéma (Dermatite Atopique), Dermatite Atopique
Clinical Study IdentifierNCT00605878
SponsorNational Human Genome Research Institute (NHGRI)
Last Modified on27 August 2021

Eligibility

Yes No Not Sure

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
Confirmed diagnosis of AD (UK Working Party s Diagnostic Criteria)24
Moderate to severe AD SCORAD greater than or equal to 25(25)
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
Males or females 2 18 years of age
Inclusion Criteria for Groups 4, 5, & 6: AD/HIES/WAS/DOCK8 patients
Must have mutation-proven diagnosis, with or without eczematous dermatitis

Exclusion Criteria

Exclusion Criteria for all groups
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
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
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.)
Underlying immunodeficiency, either as primary disease or secondary to treatment
Exclusion Criteria specific for Groups 4, 5, & 6: HIES/WAS/DOCK8 patients
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
Underlying immunodeficiency, either as primary disease or secondary to treatment
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
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
Subjects with asthma
Any female with symptoms and/or serum hormone levels consistent with perimenopause
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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