RecruitingNCT02471352Updated Nov 10, 2026

Studies of Dermatologic Diseases Biospecimen Acquisition Protocol

An observational study in Dermatologic Conditions, Healthy Volunteers and Normal Volunteers, sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS). Recruiting at 1 site in United States. Open to participants aged 1 Day to 100 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-10.

Sponsored by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) · Observational

From the registry’s dates

Started Jun 2015; still recruiting 11 years 4 months later.

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 700
Ages: 1 Day to 100 Years
Sex: All

Study 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.

Read the detailed 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 for 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 700 consented subjects planned over 10 years.

Conditions studied

Dermatologic Conditions
Healthy Volunteers
Normal Volunteers
Carcinoma, Merkel Cell

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Keywords

Dermatologic Condition
Skin Disease
Biospecimen
Healthy Volunteers
Merkel Cell Carcinoma
Natural History

In context

Carcinoma, Merkel Cell

150 studies on the registry are indexed under Carcinoma, Merkel Cell; 40 are open to participants now.

This study's planned enrollment of 700 is above the median of 92 across 12 observational studies indexed under Carcinoma, Merkel Cell.

Browse Carcinoma, Merkel Cell studies →

Lead sponsor

National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) is the lead sponsor of 100 studies on the registry; 12 are open to participants now.

Of its 7 completed or terminated interventional studies of FDA-regulated products, 5 (71%) have results posted.

Browse National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) studies →

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 1 Day to 100 Years
Sexes eligible: All
Accepts healthy volunteers: Yes
Sampling method: Non-probability sample

Study population

Referrals of eligible subjects currently undergoing evaluation and/or treatment at the NIH Clinical Center

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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 0 years old (including only viable neonates) are eligible.

Exclusion criteria

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.

Study design

Observational model: Cohort
Time perspective: Prospective
Enrollment: 700 participants (estimated)

Groups and cohorts

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

What researchers measure

Primary outcomes

Procure biologic samples for exploratory cellular, molecular, genetic and genomic biological studies
Collection of biologic samples
Time frame: Time of collection

Study locations

1 of 1 sites recruiting

National Institutes of Health Clinical Center
Bethesda, Maryland 20892, United States
Recruiting
- Office of Patient Recruitment (OPR) · Contact · ccopr@nih.gov · 800-411-2222
Recruiting

References and documents

Publications

Ahmed N, Joglekar P, Deming C; NISC Comparative Sequencing Program; Lemon KP, Kong HH, Segre JA, Conlan S. Genomic characterization of the C. tuberculostearicum species complex, a prominent member of the human skin microbiome. mSystems. 2023 Dec 21;8(6):e0063223. doi: 10.1128/msystems.00632-23. Epub 2023 Nov 10. PubMed 38126779 ↗

Individual participant data

Plan to share: Undecided — Protocol is silent on sharing IPD.

Timeline

1 registry update since Sep 25, 2026

ElapsedEstimatedEstimated, not yet reached

Started Jun 2015 (actual). Primary completion is estimated for Jan 2035, 235 months after the start.

How these figures are worked out, and which studies are left out of them.

Registered: Jun 12, 2015
First posted: Jun 15, 2015
StartActual: Jun 19, 2015
Primary completionEst.: Jan 31, 2035
CompletionEst.: Jan 31, 2035
Last update: Nov 10, 2026

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

Minor edits

Nothing that changes what the study is or who can join. Edited: verification date

1 update, last Nov 4, 2026

Show all 1 update

Nov 4, 2026
Minor edits only
+ 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02471352
Lead sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
Responsible party: Sponsor
First posted: Jun 15, 2015
Start date: Jun 19, 2015
Primary completion: Jan 31, 2035 (estimated)
Completion: Jan 31, 2035 (estimated)
Last update: Nov 10, 2026

Study contacts

Heidi H Kong, M.D.

Contact

NIAMSderm@nih.gov

(301) 827-2460

Heidi H Kong, M.D.

principal investigator · National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Oversight

FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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Discussion

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