Evaluation and Treatment of Patients With Dermatologic Diseases

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.

Study Overview

• Status: Recruiting
• Conditions: Dermatologic Diseases; Systemic Diseases With Cutaneous Manifestations

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 Type: Observational
• Enrollment (Estimated): 500

Contacts and Locations

• Study Contact: Name: Kelli A Karacki, P.A.-C; Phone Number: (301) 402-7806; Email: kelli.karacki@nih.gov
• Study Contact Backup: Name: Edward W Cowen, M.D.; Phone Number: (301) 827-2328; Email: ec176r@nih.gov

Study Locations

• United States
  • Maryland
    • Bethesda, Maryland, United States, 20892
      • Recruiting
      • National Institutes of Health Clinical Center
      • Contact: For more information at the NIH Clinical Center contact Office of Patient Recruitment (OPR); Phone Number: TTY dial 711 800-411-1222; Email: ccopr@nih.gov

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with dermatologic diseases and systemic diseases with cutaneous manifestations

Description

• 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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort
Patients; With dermatologic diseases and systemic diseases with cutaneous manifestations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Provide clinical material	Provide clinical material	Ongoing
Natural history of selected dermatologic diseases	Natural history of selected dermatologic diseases	Ongoing

Collaborators and Investigators

• Sponsor: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)
• Investigators: Principal Investigator: Edward W Cowen, M.D., National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

Publications and helpful links

Helpful Links

• NIH Clinical Center Detailed Web Page

Study record dates

Study Major Dates

• Study Start (Actual): August 22, 1996

Study Registration Dates

• First Submitted: November 3, 1999
• First Submitted That Met QC Criteria: November 3, 1999
• First Posted (Estimated): November 4, 1999

Study Record Updates

• Last Update Posted (Actual): March 27, 2024
• Last Update Submitted That Met QC Criteria: March 26, 2024
• Last Verified: June 15, 2023

More Information

Terms related to this study

• Keywords: Training; Natural History; Consultation; Standard Therapy; Standard Tests
• Additional Relevant MeSH Terms: Skin Diseases
• Other Study ID Numbers: 960102; 96-AR-0102

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: .Protocol is silent on individual participant data (IPD) sharing plan.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No