Characteristics of Patients With Dystrophic Epidermolysis Bullosa

This study is currently recruiting participants. (see Contacts and Locations)

Verified February 2015 by Stanford University

Sponsor:

Information provided by (Responsible Party):

Jean Yuh Tang, Stanford University

ClinicalTrials.gov Identifier:

NCT01019148

First received: November 20, 2009

Last updated: February 11, 2015

Last verified: February 2015

History of Changes

Purpose

Dystrophic epidermolysis bullosa (DEB) is a group of diseases caused by genetic mutations in the gene for type VII collagen. DEB can be severe or mild with the recessive disease usually being more severe. Patients with DEB develop large, severely painful blisters and open wounds from minor trauma to their skin. We are screening subjects with DEB to evaluate characteristics of the subjects and their cells in order to develop new strategies of therapy.

Condition
Epidermolysis Bullosa Dystrophica


Study Type:	Observational
Study Design:	Observational Model: Case-Only Time Perspective: Prospective
Official Title:	Characteristics of Patients With Dystrophic Epidermolysis Bullosa

Resource links provided by NLM:

Genetics Home Reference related topics: dystrophic epidermolysis bullosa epidermolysis bullosa simplex epidermolysis bullosa with pyloric atresia junctional epidermolysis bullosa

Genetic and Rare Diseases Information Center resources: Dystrophic Epidermolysis Bullosa Epidermolysis Bullosa

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:

Identification of subjects with Dystrophic Epidermolysis Bullosa [ Time Frame: 4 years ] [ Designated as safety issue: No ]
Identification of subjects with Dystrophic Epidermolysis Bullosa for future studies

Biospecimen Retention: Samples With DNA

Skin biopsies, serum


Estimated Enrollment:	30
Study Start Date:	November 2009
Estimated Study Completion Date:	April 2015
Estimated Primary Completion Date:	April 2015 (Final data collection date for primary outcome measure)

Eligibility


Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

Patients diagnosed with DEB by a local dermatologist, who are medically stable enough to travel to Stanford University Medical Center.

Criteria

Inclusion Criteria:Clinical diagnosis of DEB by local dermatologist

Exclusion Criteria:Medical instability limiting ability to travel to Stanford University Medical Center

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01019148

Contacts


Contact: Kylie Loutit, BS	(650) 721-7166	kloutit@stanford.edu

Locations


United States, California
Stanford University School of Medicine	Recruiting
Stanford, California, United States, 94305
Contact: Kylie Loutit, BS 650-721-7166 kloutit@stanford.edu
Principal Investigator: Jean Tang, MD, PhD
Sub-Investigator: Paul A. Khavari, MD
Sub-Investigator: M. Peter Marinkovich, MD
Sub-Investigator: Anthony Oro, MD
Sub-Investigator: Marius Wernig, MD

Sponsors and Collaborators

Stanford University

Investigators


Principal Investigator:	Jean Tang, MD, PhD	Stanford University

More Information

No publications provided


Responsible Party:	Jean Yuh Tang, Associate Professor, Stanford University
ClinicalTrials.gov Identifier:	NCT01019148 History of Changes
Other Study ID Numbers:	SU-11182009-4402
Study First Received:	November 20, 2009
Last Updated:	February 11, 2015
Health Authority:	United States: Institutional Review Board

Additional relevant MeSH terms:


Epidermolysis Bullosa Epidermolysis Bullosa Dystrophica Collagen Diseases Congenital Abnormalities Connective Tissue Diseases	Genetic Diseases, Inborn Skin Abnormalities Skin Diseases Skin Diseases, Genetic Skin Diseases, Vesiculobullous

ClinicalTrials.gov processed this record on March 02, 2015

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