Studies of Dermatologic Diseases Biospecimen Acquisition Protocol

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Studies of Dermatologic Diseases Biospecimen Acquisition Protocol

Study Purpose

Background:

- Skin disease can have many causes.

It can have widespread consequences, and in rare cases can lead to death. Researchers want to determine the causes of various types of skin diseases and find a way to treat them. Objectives:

- To determine the causes of various skin diseases and find ways to treat them.

Eligibility:

- People ages 2 and older who have: - A skin disease or at risk of developing a skin disease OR.

- A family member of persons with a skin disease.

- Healthy volunteers ages 2 and older.

Design:

- Participants will be screened under a separate protocol.

- Participants may take a survey about how their skin condition affects their quality of life.

- Participants will have a medical history and a physical exam including a detailed skin exam.

Pictures will be taken of their skin to document any skin disease.

- Participants will have specimens collected.

This may include:

- Several teaspoons of blood taken at each visit.

- Stool samples.

- Nail and body fluid (like saliva) samples.

- Cheek swabs.

The inside of the cheek will be scraped for about a minute in each direction to collect cells.

- Collection of skin samples with: - A swab (like a Q-tip) - Gently scraping skin to remove the outer layers of cells.

- Applying and removing 1-inch pieces of tape.

- Participants may have up to 4 skin biopsies in 12 months, with 4 separate biopsies taken each time.

- An area of skin will be numbed with an injection.

- A piece of skin the size of a pencil eraser will be removed using a small instrument.

- A flat scar usually develops at the biopsy site.

Recruitment Criteria

Accepts Healthy Volunteers Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms	Yes
Study Type An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes. An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes. Searching Both is inclusive of interventional and observational studies.	Observational
Eligible Ages	1 Day and Over
Gender	All

More Inclusion & Exclusion Criteria

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INCLUSION CRITERIA:
- Eligible participants must: - Have a dermatologic condition, as determined by the PI or AIs, OR be at risk for developing a dermatologic condition, as determined by the PI or AIs, OR be a family member of a person with a dermatologic condition OR be a healthy volunteer, as defined as a person with no known significant health problems.

- Be willing to provide biospecimens for research and clinical studies, and for storage to be used for future research.

- Subjects of age greater than or equal to 2 years old are eligible.

EXCLUSION CRITERIA:

- Presence of conditions that, in the judgment of the investigator, may put the subject at undue risk or make them unsuitable for participation in the study.

- Inability to comply with the requirements of the protocol.

Trial Details

Trial ID: This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.	NCT02471352
Phase Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans. Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data. Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs. Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
Lead Sponsor The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Principal Investigator The person who is responsible for the scientific and technical direction of the entire clinical study.	Heidi H Kong, M.D.
Principal Investigator Affiliation	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Agency Class Category of organization(s) involved as sponsor (and collaborator) supporting the trial.	NIH
Overall Status	Recruiting
Countries	United States
Conditions The disease, disorder, syndrome, illness, or injury that is being studied.	Dermatologic Conditions, Healthy Volunteers, Normal Volunteers, Carcinoma, Merkel Cell
Study Website:	View Trial Website

Additional Details

Background:

- Skin diseases represent one of the most common medical problems in the United States, affecting 1 in 3 people at any given time.

- Complex interactions between genetic background and the environment are relevant to understanding skin disease.

- By studying dermatoses, we may gain insight into the complex host-environment interactions that give rise to or exacerbate these skin conditions, and into links between inflammation and cancer.

Objective: -To procure biologic samples for exploratory cellular, molecular, genetic and genomic biological studies from subjects with dermatologic conditions, subjects at risk for developing dermatologic conditions and healthy volunteers in the support of NIH biomedical studies. Eligibility: -Subjects with or at risk of developing dermatologic diseases, family members of subjects with dermatologic diseases, or healthy volunteers, including adults and children. Design:

- The purpose of this study is to examine, in an exploratory fashion, a variety of biologic assays relevant to the investigation of dermatologic diseases.

- Approximately 50 subjects are anticipated to consent to the study each year with an accrual ceiling of 500 consented subjects planned over 10 years.

Arms & Interventions

Arms

: 1/ Skin disease or at risk

Subjects with a skin disease or at risk of developing a skin disease/ Family member of persons with a skin disease

: 2/ Healthy Volunteers

Healthy Volunteers

Interventions

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Bethesda, Maryland

Status

Recruiting

Address

National Institutes of Health Clinical Center

Bethesda, Maryland, 20892

Site Contact

For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR)

[email protected]

800-411-1222 #TTY dial 711