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NCT00004761 Clinical Trial

Establishment of the National Epidermolysis Bullosa Registry

Epidermolysis Bullosa Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00004761
Other study ID # 199/11706
Secondary ID RU-0170195
Status Completed
Phase N/A
First received February 24, 2000
Last updated June 23, 2005
Start date September 1986

Study information
Verified date July 2004
Source Office of Rare Diseases (ORD)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Observational

Clinical Trial Summary

OBJECTIVES: I. Develop a large roster of well-characterized patients with various forms of inherited and acquired epidermolysis bullosa (EB).

II. Generate a large data bank of clinical, historical, and genetic information concerning these patients.

III. Accumulate donated tissue specimens, including selected cells and DNA, from selected patient subsets for the establishment of permanent tissue cell banks.

IV. Promote and facilitate research in EB.

Description:

PROTOCOL OUTLINE: Patients are enrolled by mail or clinic visit at 1 of 4 clinical centers. Clinical, epidemiological, and laboratory data are collected.

Medical and family histories are obtained in a detailed interview in person, by phone, or by mail. Diagnostic studies to confirm the type of epidermolysis bullosa are performed as indicated. A pedigree chart is completed on the first affected family member entered.

Selected patients are followed at least biannually. A study duration of approximately 10 years is anticipated.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility - Clinical diagnosis of epidermolysis bullosa

Study Design

Observational Model: Natural History, Time Perspective: Longitudinal

Related Conditions & MeSH terms

Locations
Country Name City State
n/a

Sponsors (3)
Lead Sponsor Collaborator
National Center for Research Resources (NCRR) National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), Rockefeller University

References & Publications (1)

Lin AN, Carter DM: Epidermolysis Bullosa: Basic and Clinical Aspects. New York: Springer Verlag, 1992.

See also
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Completed NCT00014729 - Phase I Study of Isotretinoin in Patients With Recessive Dystrophic Epidermolysis Bullosa Phase 1
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Completed NCT02582775 - MT2015-20: Biochemical Correction of Severe EB by Allo HSCT and Serial Donor MSCs Phase 2
Recruiting NCT04213703 - A Pilot Study to Explore the Role of Gut Flora in Epidermolysis Bullosa
Completed NCT02384460 - ESSENCE Study: Efficacy and Safety of SD-101 Cream in Participants With Epidermolysis Bullosa Phase 3
Terminated NCT02670330 - Open Label Extension Study to Evaluate the Long-term Safety of Zorblisa (SD-101-6.0) in Patients With Epidermolysis Bullosa Phase 3
Terminated NCT01619670 - A Observational Study to Evaluate Apligraf(R) in Nonhealing Wounds of Subjects With Epidermolysis Bullosa Phase 4
Recruiting NCT01340235 - Treatment of Dowling Maera Type of Epidermolysis Bullosa Simplex by Oral Erythromycin Phase 3
Completed NCT02014376 - Study of Effectiveness and Safety of SD-101 in Participants With Epidermolysis Bullosa Phase 2
Completed NCT04217538 - Observational Study of a Cohort of Patients With Hereditary Epidermolysis Bullosa
Completed NCT03942250 - Uses of Irradiated Human Amniotic Membrane in the Treatment of Dystrophic Epidermolysis Bullosa Patients N/A
Completed NCT01033552 - Biochemical Correction of Severe EB by Allo HSCT and "Off-the-shelf" MSCs Phase 1/Phase 2
Completed NCT04227106 - Phase 3, Open-label Clinical Trial of EB-101 for the Treatment of Recessive Dystrophic Epidermolysis Bullosa (RDEB) Phase 3