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Characteristics of Patients With Dystrophic Epidermolysis Bullosa

This study is currently recruiting participants.
Verified December 2012 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Alfred Lane, Stanford University
ClinicalTrials.gov Identifier:
NCT01019148
First received: November 20, 2009
Last updated: December 12, 2012
Last verified: December 2012
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:

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


Estimated Enrollment: 20
Study Start Date: November 2009
Estimated Study Completion Date: April 2014
Estimated Primary Completion Date: April 2014 (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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01019148

Contacts
Contact: Emily Gorell, MS (650) 721-7166 egorell@stanford.edu
Contact: Andrea Tichy, PhD (650) 721-7166 atichy@stanford.edu

Locations
United States, California
Stanford University School of Medicine Recruiting
Stanford, California, United States, 94305
Contact: Emily Gorell, MS     650-721-7166     egorell@stanford.edu    
Contact: Andrea Tichy, PhD     (650) 721-7166     atichy@stanford.edu    
Principal Investigator: Alfred T Lane            
Sub-Investigator: Paul A. Khavari            
Sub-Investigator: M. Peter Marinkovich M.D.            
Sub-Investigator: Anthony Oro            
Sub-Investigator: Marius Wernig            
Sponsors and Collaborators
Stanford University
Investigators
Principal Investigator: Alfred T Lane Stanford University
  More Information

No publications provided

Responsible Party: Alfred Lane, Professor of Dermatology and Pediatrics, Stanford University
ClinicalTrials.gov Identifier: NCT01019148     History of Changes
Other Study ID Numbers: SU-11182009-4402
Study First Received: November 20, 2009
Last Updated: December 12, 2012
Health Authority: United States: Institutional Review Board

Additional relevant MeSH terms:
Epidermolysis Bullosa
Epidermolysis Bullosa Dystrophica
Skin Abnormalities
Congenital Abnormalities
Skin Diseases, Genetic
 Genetic Diseases, Inborn
Skin Diseases
Skin Diseases, Vesiculobullous
Collagen Diseases
Connective Tissue Diseases

ClinicalTrials.gov processed this record on May 19, 2013