Studies of Dermatologic Diseases Biospecimen Acquisition Protocol

Healthy Volunteers Clinical Trial

Official title: Studies of Dermatologic Diseases-Biospecimen Acquisition Protocol

Status Recruiting

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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

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

• NCT number: NCT02471352
• Study type: Observational
• Source: National Institutes of Health Clinical Center (CC)
• Contact: Monica Taylor, R.N.
• Phone: (301) 451-2221
• Email: monica.taylor@nih.gov
• Status: Recruiting
• Start date: June 19, 2015
• Completion date: January 31, 2027