Dermatologic ConditionsNCT02471352
Studies of Dermatologic Diseases Biospecimen Acquisition Protocol
An observational study of Dermatologic Conditions and Healthy Volunteers, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 1 day to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Dermatologic Conditions, Healthy Volunteers, Normal Volunteers
- How many people
- 700 participants
- Where
- 1 siteUnited States
- Study dates
- 19 Jun 2015to 31 Jan 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 1 day to 100 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Referrals of eligible subjects currently undergoing evaluation and/or treatment at the NIH Clinical Center
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
Office of Patient Recruitment (OPR), 800-411-2222, ccopr@nih.gov
About this study
Official title: Studies of Dermatologic Diseases-Biospecimen Acquisition Protocol
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.
Read more
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.
- Keywords
- Dermatologic Condition, Skin Disease, Biospecimen, Healthy Volunteers, Merkel Cell Carcinoma, Natural History
- Medical subject headings
- Carcinoma, Merkel Cell, Skin Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 is being measured
The primary outcome is the main question the study is designed to answer.
Procure biologic samples for exploratory cellular, molecular, genetic and genomic biological studies
Collection of biologic samples
Measured: Time of collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Jun 2015 (estimated)
- Study start19 Jun 2015
- Primary completion31 Jan 2035 (estimated)
- Study completion31 Jan 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dermatologic ConditionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 700 participants (estimated)
Sponsor and investigators
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
- Sponsor type
- US National Institutes of Health
- Responsible party
- Sponsor
- Investigators
- Heidi H Kong, M.D., Principal investigator, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02471352
- Sponsor's protocol ID
- 150144
- Other IDs
- 15-AR-0144
- Status last verified
- 18 Sep 2026
- First submitted
- 12 Jun 2015
- Last updated
- 22 Sep 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Protocol is silent on sharing IPD.
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
Study at a glance
From the registry record, last updated by the sponsor on 22 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Studies of Dermatologic Diseases-Biospecimen Acquisition Protocol
- ClinicalTrials.gov ID
- NCT02471352
- Acronym / sponsor ID
- 150144
- Keywords
- Dermatologic Condition, Skin Disease, Biospecimen, Healthy Volunteers, Merkel Cell Carcinoma, Natural History
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 700 participants (estimated)
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)US National Institutes of Health
- Study start
- 19 Jun 2015 (actual)
- Primary completion
- 31 Jan 2035 (estimated)
- Study completion
- 31 Jan 2035 (estimated)
- First posted
- 15 Jun 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 1 day to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Referrals of eligible subjects currently undergoing evaluation and/or treatment at the NIH Clinical Center
Key inclusion criteria (6 listed)
- Eligible participants must:
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Procure biologic samples for exploratory cellular, molecular, genetic and genomic biological studies
Time frame: Time of collection
Collection of biologic samples
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Sep 2026.
- Derived from this study: PubMed 38126779Ahmed 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.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Protocol is silent on sharing IPD.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Heidi H Kong, M.D. principal investigator
National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Dermatologic Conditions and Healthy Volunteers, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Heidi H Kong, M.D. ((301) 827-2460, NIAMSderm@nih.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Procure biologic samples for exploratory cellular, molecular, genetic and genomic biological studies (time frame: Time of collection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02471352, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Sep 2026.