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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 : November 19, 2019
Sponsor:
Information provided by (Responsible Party):
National Institutes of Health Clinical Center (CC) ( National Human Genome Research Institute (NHGRI) )

Tracking Information
First Submitted Date January 23, 2008
First Posted Date January 31, 2008
Last Update Posted Date November 19, 2019
Actual Study Start Date January 22, 2008
Primary Completion Date Not Provided
Current Primary Outcome Measures
 (submitted: February 16, 2019)
  • 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
Original Primary Outcome Measures Not Provided
Change History Complete list of historical versions of study NCT00605878 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Studies of Skin Microbes in Healthy People and in People With Skin Conditions
Official Title Studies of Skin Microflora in Healthy Individuals and Atopic Dermatitis Patients
Brief 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.

Detailed 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.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study 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)@@@10.8@@@* Sampling
Condition
  • Atopic Dermatitis
  • Eczema
  • Ichthyosis Vulgaris
Intervention Not Provided
Study Groups/Cohorts
  • Grouo 3
    Healthy (pediatric) controls
  • Group 1
    Healthy (adult) volunteers
  • Group 2
    AD patients
  • Group 4
    Patients diagnosed with the primary immunodeficiency hyperIgE syndrome (HIES)
  • Group 5
    Patients diagnosed with the primary immunodeficiency Wiskott-Aldrich Syndrome (WAS)
  • Group 6
    Patients diagnosed with the combined immunodeficiency associated with DOCK8 mutation (DOCK8)
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: October 13, 2016)
530
Original Enrollment
 (submitted: January 26, 2008)
280
Study Completion Date Not Provided
Primary Completion Date Not Provided
Eligibility 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 with unstable or uncontrolled or chronic medical conditions requiring treatment or hospitalization. Individual determinations will be made at the discretion of the medical investigator.
  2. 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.
  3. 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.
  4. 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 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. Underlying immunodeficiency, either as primary disease or secondary to treatment.

    B. 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.

    C. 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.

    D. Subjects with asthma.

  5. Any female with symptoms and/or serum hormone levels consistent with perimenopause
Sex/Gender
Sexes Eligible for Study: All
Ages 2 Years to 50 Years   (Child, Adult)
Accepts Healthy Volunteers Yes
Contacts
Contact: Lei Zhu, R.N. (301) 827-6586 lei.zhu3@nih.gov
Contact: Julie A Segre, Ph.D. (301) 402-2314 js608m@nih.gov
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT00605878
Other Study ID Numbers 080059
08-HG-0059
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party National Institutes of Health Clinical Center (CC) ( National Human Genome Research Institute (NHGRI) )
Study Sponsor National Human Genome Research Institute (NHGRI)
Collaborators Not Provided
Investigators
Principal Investigator: Julie A Segre, Ph.D. National Human Genome Research Institute (NHGRI)
PRS Account National Institutes of Health Clinical Center (CC)
Verification Date September 12, 2019