Studies of Skin Microbes in Healthy People and in People With Skin Conditions
|First Received Date ICMJE||January 23, 2008|
|Last Updated Date||November 27, 2013|
|Start Date ICMJE||January 2008|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||Identify skin bacterial diversity|
|Original Primary Outcome Measures ICMJE||Not Provided|
|Change History||Complete list of historical versions of study NCT00605878 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
||Exploration of common and rare microflora species that reside on human skin in normal and disease state|
|Original Secondary Outcome Measures ICMJE||Not Provided|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||Studies of Skin Microbes in Healthy People and in People With Skin Conditions|
|Official Title ICMJE||Studies of Skin Microflora in Healthy Individuals and Atopic Dermatitis Patients|
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:
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.
Skin microflora (bacteria, fungi, viruses, phage, archae) play a significant role in common dermatological conditions, such as atopic dermatitis (a common form of eczema).
Since culture-dependent methods are often biased assessments of microbial diversity, genomic methods can expand our understanding of human microflora (human microbiome) and skin diseases.
Chronic dermatitis is typical of rare primary immunodeficiencies: Wiskott-Aldrich syndrome; hyper-IgE syndrome (HIES); 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 ICMJE||Observational|
|Study Design ICMJE||Time Perspective: Prospective|
|Target Follow-Up Duration||Not Provided|
|Sampling Method||Not Provided|
|Study Population||Not Provided|
|Intervention ICMJE||Not Provided|
|Study Group/Cohort (s)||Not Provided|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Recruiting|
|Estimated Enrollment ICMJE||390|
|Completion Date||Not Provided|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
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 18-40 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:
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. 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.
|Ages||2 Years to 40 Years|
|Accepts Healthy Volunteers||Yes|
|Location Countries ICMJE||United States|
|NCT Number ICMJE||NCT00605878|
|Other Study ID Numbers ICMJE||080059, 08-HG-0059|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||National Human Genome Research Institute (NHGRI)|
|Collaborators ICMJE||Not Provided|
|Information Provided By||National Institutes of Health Clinical Center (CC)|
|Verification Date||June 2013|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP