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A Prospective Study to Evaluate the Natural History of Wounds in Patients With Dystrophic Epidermolysis Bullosa (DEB)
This study is a non-interventional, observational study that will evaluate the natural history of wounds in patients with Dystrophic Epidermolysis Bullosa (DEB) for inclusion into the Krystal Biotech Phase III protocol of B-VEC (previously KB103). Wound recurrence and wound size will be evaluated for up to four months.
The objective of this study is to analyze the selected wounds' natural history prior to including the selected wounds in the evaluation of safety and efficacy in Krystal Biotech's Phase III protocol of B-VEC. Subjects will be enrolled upon obtaining consent and meeting eligibility criteria. Patient Screening is done on-site, followed by the imaging of at least 1 wound, but up to 15 wounds. All remaining imaging will be performed remotely with a smartphone or tablet application. Patients are on-trial for approximately four months.
Age
0 - No limit years
Sex
ALL
Healthy Volunteers
No
Stanford University
Redwood City, California, United States
Start Date
January 1, 2020
Primary Completion Date
February 24, 2020
Completion Date
February 24, 2020
Last Updated
September 17, 2021
Lead Sponsor
Krystal Biotech, Inc.
Collaborators
NCT05157958
NCT04213261
NCT06892639
Data Source & Attribution
This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.
Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.
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