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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
  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:


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 03, 2015