Dermatologic DiseasesNCT00001506
Evaluation and Treatment of Patients With Dermatologic Diseases
An observational study of Dermatologic Diseases and Systemic Diseases With Cutaneous Manifestations, run by National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS) at 1 site in United States.
Trial summary
This is a training, natural history of disease, and screening protocol for the evaluation, treatment and follow-up of patients with dermatologic diseases and systemic diseases with cutaneous manifestations. Read more about this study
- Who is it for?
- Ages 1 day to 120 years
- Conditions the study is for
- Dermatologic Diseases, Systemic Diseases With Cutaneous Manifestations
- How many people
- 453 participants
- Where
- 1 siteUnited States
- Study dates
- 22 Aug 1996to 1 Apr 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
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 120 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Patients with dermatologic diseases and systemic diseases with cutaneous manifestations
Who may be able to join
- Patients of any age (only viable neonates will enroll in the study), of both genders, and all racial/ethnic groups with dermatologic diseases or systemic diseases with cutaneous manifestations that will help the Branch fulfill the objectives.
- Women who are pregnant or lactating, will only undergo tests and procedures, and/or receive medications for which data exists proving minimal risk to the fetus and/or child.
- Patients must have a referring physician who will continue to assume primary medical responsibility of care for the patient during and after enrollment in this protocol.
Who cannot join
- Any participant who, in the investigator s opinion, would be unable to comply with study requirements or for whom participation may pose a greater medical risk.
Trial locations and contacts
1 site in 1 country.
United States1 site
National Institutes of Health Clinical Center
Bethesda, Maryland, 20892
About this study
Official title: Evaluation and Treatment of Subjects With Dermatologic Diseases
This is a training, natural history of disease, and screening protocol for the evaluation, treatment and follow-up of patients with dermatologic diseases and systemic diseases with cutaneous manifestations. Patients enrolled in this protocol will be evaluated and treated according to generally available, standard procedures and therapeutic modalities. Samples of blood and skin will be studied by routine and specialized investigative methods to establish these patients' diagnosis, response to treatment, and/or disease progression.
Read the detailed description
Background
This is a training, natural history of disease, and screening protocol for the evaluation, treatment and follow-up of patients with dermatologic diseases and systemic diseases with cutaneous manifestations. This protocol was developed to allow subject enrollment for teaching purposes and to allow for second opinions regarding relatively complicated patients, and to allow for evaluation of non-invasive tools for the diagnosis and monitoring of cutaneous manifestations. This protocol promotes a critical link between the NCI, CCR Dermatology Branch and the local and national extramural medical communities.
Objectives:
- To provide clinical material to fulfill the educational mission of the Dermatology Branch.
- To learn about the natural history of selected dermatologic diseases.
Eligibility:
All subjects regardless of age, gender, or racial/ethnic group with dermatologic disease or systemic disease with cutaneous manifestations.
Design:
Patients enrolled in this protocol will be evaluated and treated according to generally available, standard procedures and therapeutic modalities. Samples of blood and skin will be studied by routine and specialized investigative methods to establish these patients diagnosis, response to treatment, and/or disease progression. Non-invasive tools may be used as part of the examination and assessment of cutaneous manifestations of disease.
- Keywords
- Training, Standard Therapy, Standard Tests, Natural History, Consultation
- Medical subject headings
- 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 |
|---|---|---|
| Patients | With dermatologic diseases and systemic diseases with cutaneous manifestations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Provide clinical material
Provide clinical material
Measured: Ongoing
Natural history of selected dermatologic diseases
Natural history of selected dermatologic diseases
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Nov 1999 (estimated)
- Study start22 Aug 1996
- Primary completion26 Mar 2025
- Study completion1 Apr 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dermatologic DiseasesStudies 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
- 453 participants (actual)
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
- Edward W Cowen, M.D., Principal investigator, National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00001506
- Sponsor's protocol ID
- 960102
- Other IDs
- 96-AR-0102
- Status last verified
- Apr 2025
- First submitted
- 3 Nov 1999
- Last updated
- 13 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Protocol is silent on individual participant data (IPD) sharing plan.
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation and Treatment of Subjects With Dermatologic Diseases
- ClinicalTrials.gov ID
- NCT00001506
- Acronym / sponsor ID
- 960102
- Keywords
- Training, Standard Therapy, Standard Tests, Natural History, Consultation
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 453 participants (actual)
- Lead sponsor
- National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)US National Institutes of Health
- Study start
- 22 Aug 1996 (actual)
- Primary completion
- 26 Mar 2025 (actual)
- Study completion
- 1 Apr 2025 (actual)
- First posted
- 4 Nov 1999 (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.
This is a training, natural history of disease, and screening protocol for the evaluation, treatment and follow-up of patients with dermatologic diseases and systemic diseases with cutaneous manifestations. Patients enrolled in this protocol will be evaluated and treated according to generally available, standard procedures and therapeutic modalities. Samples of blood and skin will be studied by routine and specialized investigative methods to establish these patients' diagnosis, response to treatment, and/or disease progression.
Detailed description
Background
This is a training, natural history of disease, and screening protocol for the evaluation, treatment and follow-up of patients with dermatologic diseases and systemic diseases with cutaneous manifestations. This protocol was developed to allow subject enrollment for teaching purposes and to allow for second opinions regarding relatively complicated patients, and to allow for evaluation of non-invasive tools for the diagnosis and monitoring of cutaneous manifestations. This protocol promotes a critical link between the NCI, CCR Dermatology Branch and the local and national extramural medical communities.
Objectives:
- To provide clinical material to fulfill the educational mission of the Dermatology Branch.
- To learn about the natural history of selected dermatologic diseases.
Eligibility:
All subjects regardless of age, gender, or racial/ethnic group with dermatologic disease or systemic disease with cutaneous manifestations.
Design:
Patients enrolled in this protocol will be evaluated and treated according to generally available, standard procedures and therapeutic modalities. Samples of blood and skin will be studied by routine and specialized investigative methods to establish these patients diagnosis, response to treatment, and/or disease progression. Non-invasive tools may be used as part of the examination and assessment of cutaneous manifestations of disease.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –With dermatologic diseases and systemic diseases with cutaneous manifestations |
Who may qualify
- Ages
- 1 day to 120 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients with dermatologic diseases and systemic diseases with cutaneous manifestations
Key inclusion criteria (3 listed)
- Patients of any age (only viable neonates will enroll in the study), of both genders, and all racial/ethnic groups with dermatologic diseases or systemic diseases with cutaneous manifestations that will help the Branch fulfill the objectives.
- Women who are pregnant or lactating, will only undergo tests and procedures, and/or receive medications for which data exists proving minimal risk to the fetus and/or child.
- Patients must have a referring physician who will continue to assume primary medical responsibility of care for the patient during and after enrollment in this protocol.
Key exclusion criteria (1 listed)
- Any participant who, in the investigator s opinion, would be unable to comply with study requirements or for whom participation may pose a greater medical risk.
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
Provide clinical material
Time frame: Ongoing
Provide clinical material
Natural history of selected dermatologic diseases
Time frame: Ongoing
Natural history of selected dermatologic diseases
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2025.
- NIH Clinical Center Detailed Web PageLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided. Protocol is silent on individual participant data (IPD) sharing plan.
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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. This study is not recruiting at the moment.
Edward W Cowen, 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 Diseases and Systemic Diseases With Cutaneous Manifestations, 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 3 inclusion and 1 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: finished, as of the sponsor's last update on 13 Apr 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Provide clinical material (time frame: Ongoing). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Apr 2025.