Studies of Skin Microbes in Healthy People and in People With Skin Conditions
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age2-100
SponsorNational Human Genome Research Institute (NHGRI)
About this trial
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.
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Eligibility criteria
This trial accepts healthy volunteersQualifiers
None
Disqualifiers
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.
Trial population
Healthy (adult) volunteers AD patients Healthy (pediatric) controls 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)
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
530 Participants
are grouped into 6 trial groups6
Trial groupsSee each trial group below.
Group A: Grouo 3
Group B: Group 1
Group C: Group 2
Group D: Group 4
Group E: Group 5
Group F: Group 6
Trial outcomes
Primary outcomes
1
Primary Immunodeficiency
Analyze the microbiome of patients with primary immunodeficiency disorders that are known to have AD-like skin disease.
Time frame
Ongoing2
Healthy volunteers
Characterize the microbiome of healthy individuals.
Time frame
OngoingSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov