Studies of Dermatologic Diseases Biospecimen Acquisition Protocol

Healthy Volunteers Clinical Trial

Official title:

Studies of Dermatologic Diseases-Biospecimen Acquisition Protocol

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02471352
• Other study ID #: 150144
• Secondary ID: 15-AR-0144
• Status: Recruiting
• Start date: June 19, 2015
• Est. completion date: January 31, 2027

Study information

• Verified date: June 7, 2024
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Monica Taylor, R.N.
• Phone: (301) 451-2221
• Email: monica.taylor[@]nih.gov
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 700
• Est. completion date: January 31, 2027
• Est. primary completion date: January 31, 2027
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 1 Day to 100 Years

Eligibility

• 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.

Related Conditions & MeSH terms

• Carcinoma, Merkel Cell
• Dermatologic Conditions
• Healthy Volunteers
• Normal Volunteers
• Skin Diseases

Locations

Country	Name	City	State
United States	National Institutes of Health Clinical Center	Bethesda	Maryland

Sponsors (1)

Lead Sponsor	Collaborator
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Procure biologic samples for exploratory cellular, molecular, genetic and genomic biological studies	Collection of biologic samples	Time of collection

External Links

•   NIH Clinical Center Detailed Web Page