Clinical trial NCT00001506: Evaluation and Treatment of Patients With Dermatologic Diseases
Official title: Evaluation and Treatment of Subjects With Dermatologic Diseases
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Dermatologic Diseases
Systemic Diseases With Cutaneous Manifestations
Keywords: Training
Standard Therapy
Standard Tests
Natural History
Consultation
Lead sponsor: National Institutes of Health Clinical Center (CC)
Sponsor class: NIH
First posted: 1999-11-04
Enrollment: 453
Sex: ALL
Minimum age (years): 1
Maximum age (years): 120
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with dermatologic diseases and systemic diseases with cutaneous manifestations

Brief 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. 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.

Eligibility criteria: * INCLUSION CRITERIA:

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.

EXCLUSION CRITERIA:

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.

Primary outcomes:
measure: Provide clinical material
timeFrame: Ongoing
measure: Natural history of selected dermatologic diseases
timeFrame: Ongoing
Secondary outcomes:
Other outcomes:
Locations:
city: Bethesda
country: United States
facility: National Institutes of Health Clinical Center
state: Maryland
Study officials:
affiliation: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
name: Edward W Cowen, M.D.
role: PRINCIPAL_INVESTIGATOR
References: