Clinical Trial: Short Term Observational Study in DEB Patients
Study Status: Completed
Recruit Status: Completed
Study Type: Observational
Official Title: A Prospective Short-term Study to Evaluate Methodologies for the Assessment of Disease Extent, Impact, and Wound Evolution in Patients With Dystrophic Epidermolysis Bullosa
Brief Summary: The purpose of this study is to better understand disease extent and to identify appropriate methodologies to evaluate (dystrophic epidermolysis bullosa) DEB in a quantitative and qualitative manner.
Detailed Summary:
Sponsor: Shire
Current Primary Outcome:
- Wound Surface Area (WSA) of patient- and investigator-selected wounds [ Time Frame: Over 4 weeks ]
- Wound Surface Area (WSA) as a percentage of Body Surface Area (BSA) in patients with DEB [ Time Frame: Over 4 weeks ]
Original Primary Outcome: Same as current
Current Secondary Outcome: The number, severity and relationship to study procedures of adverse events (AEs) and serious AEs (SAEs) [ Time Frame: Over 4 weeks ]
Original Secondary Outcome: Same as current
Information By: Shire
Dates:
Date Received: June 4, 2014
Date Started: June 2014
Date Completion:
Last Updated: May 28, 2015
Last Verified: March 2015
