Trial record 8 of 18 for:    "nonbullous congenital ichthyosiform erythroderma" OR "Congenital Ichthyosiform Erythrodermas" OR "Congenital Ichthyosiform Erythroderma" OR "Ichthyosiform Erythroderma, Congenital" OR "Ichthyosis"

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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by National Institutes of Health Clinical Center (CC)
Sponsor:
Information provided by:
National Institutes of Health Clinical Center (CC)
ClinicalTrials.gov Identifier:
NCT00605878
First received: January 23, 2008
Last updated: August 23, 2014
Last verified: April 2014
  Purpose

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.


Condition
Atopic Dermatitis
Eczema
Ichthyosis Vulgaris

Study Type: Observational
Study Design: Time Perspective: Prospective
Official Title: Studies of Skin Microflora in Healthy Individuals and Atopic Dermatitis Patients

Resource links provided by NLM:


Further study details as provided by National Institutes of Health Clinical Center (CC):

Primary Outcome Measures:
  • Identify skin bacterial diversity

Secondary Outcome Measures:
  • Exploration of common and rare microflora species that reside on human skin in normal and disease state

Estimated Enrollment: 500
Study Start Date: January 2008
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   2 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  5. Any female with symptoms and/or serum hormone levels consistent with perimenopause.

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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00605878

Contacts
Contact: Sheila E Phang, R.N. (301) 496-8724 sphang@mail.nih.gov
Contact: Julia A Segre, Ph.D. (301) 402-2314 js608m@nih.gov

Locations
United States, Maryland
National Institutes of Health Clinical Center, 9000 Rockville Pike Recruiting
Bethesda, Maryland, United States, 20892
Contact: For more information at the NIH Clinical Center contact Patient Recruitment and Public Liaison Office (PRPL)    800-411-1222 ext TTY8664111010    prpl@mail.cc.nih.gov   
Contact: Irene Ekwede, B.S.N.    (301) 402-6225    irene.ekwede@nih.gov   
Sponsors and Collaborators
Investigators
Principal Investigator: Julia A Segre, Ph.D. National Human Genome Research Institute (NHGRI)
  More Information

Additional Information:
Publications:
ClinicalTrials.gov Identifier: NCT00605878     History of Changes
Other Study ID Numbers: 080059, 08-HG-0059
Study First Received: January 23, 2008
Last Updated: August 23, 2014
Health Authority: United States: Federal Government

Keywords provided by National Institutes of Health Clinical Center (CC):
Atopic Dermatitis (Eczema)
Bacteria
Filaggrin
Skin
Microbiome
Atopic Dermatitis
Eczema
Health Volunteer
HG

Additional relevant MeSH terms:
Ichthyosis Vulgaris
Ichthyosis
Dermatitis, Atopic
Dermatitis
Skin Diseases, Genetic
Genetic Diseases, Inborn
Skin Diseases
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Skin Abnormalities
Congenital Abnormalities
Keratosis

ClinicalTrials.gov processed this record on September 16, 2014