NCT02471352

Studies of Dermatologic Diseases Biospecimen Acquisition Protocol

Recruiting now Last updated 11 March 2026

What this trial tests

trial in Dermatologic Conditions in 700 participants. Currently enrolling.

Timeline

19 June 2015

Primary endpoint
31 January 2027

31 January 2027

Quick facts

Lead sponsor	National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Status	Recruiting now
Study type	OBSERVATIONAL
Enrollment	700
Start date	19 June 2015
Primary completion	31 January 2027
Estimated completion	31 January 2027
Sites	1 location across United States

Conditions studied

• Dermatologic Conditions — all drugs for Dermatologic Conditions →
• Healthy Volunteers — all drugs for Healthy Volunteers →
• Normal Volunteers — all drugs for Normal Volunteers →
• Carcinoma, Merkel Cell — all drugs for Carcinoma, Merkel Cell →

Sponsor

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Who can join

Adults 1 Day to 100, any sex, with Dermatologic Conditions or Healthy Volunteers. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

5 peer-reviewed publications reference this trial (live from Europe PMC):

1. Integrated genomic and functional analyses of human skin-associated <i>Staphylococcus</i> reveal extensive inter- and intra-species diversity.
   Joglekar P, Conlan S, Lee-Lin SQ, Deming C, et al · · 2023 · cited 29× · PMID 37956283 · DOI 10.1073/pnas.2310585120
2. Predicting cancer immunotherapy response from gut microbiomes using machine learning models.
   Liang H, Jo JH, Zhang Z, MacGibeny MA, et al · · 2022 · cited 29× · PMID 35875611 · DOI 10.18632/oncotarget.28252
3. Genomic characterization of the <i>C. tuberculostearicum</i> species complex, a prominent member of the human skin microbiome.
   Ahmed N, Joglekar P, Deming C, NISC Comparative Sequencing Program, et al · · 2023 · cited 17× · PMID 38126779 · DOI 10.1128/msystems.00632-23
4. Expanded microbiome niches of RAG-deficient patients.
   Blaustein RA, Shen Z, Kashaf SS, Lee-Lin S, et al · · 2023 · cited 6× · PMID 37757827 · DOI 10.1016/j.xcrm.2023.101205
5. Exploring the Skin Microbiome in Central Centrifugal Cicatricial Alopecia.
   Firek A, Hou P, Han J, Holmes CJ, et al · · 2025 · PMID 39813050 · DOI 10.1001/jamadermatol.2024.5421