The Natural History of Wounds in Patients With Dystrophic Epidermolysis Bullosa (DEB)
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|ClinicalTrials.gov Identifier: NCT04214002|
Recruitment Status : Withdrawn (Due to the COVID-19 Pandemic, the study was withdrawn.)
First Posted : December 30, 2019
Last Update Posted : September 17, 2021
|Condition or disease|
|Dystrophic Epidermolysis Bullosa DEB - Dystrophic Epidermolysis Bullosa|
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.
|Study Type :||Observational|
|Actual Enrollment :||0 participants|
|Official Title:||A Prospective Study to Evaluate the Natural History of Wounds in Patients With Dystrophic Epidermolysis Bullosa (DEB)|
|Estimated Study Start Date :||January 2020|
|Actual Primary Completion Date :||February 24, 2020|
|Actual Study Completion Date :||February 24, 2020|
- Change in wound surface area [ Time Frame: Up to four months ]Percent change in wound surface area from baseline will be measured from images uploaded to an imaging application.
- Time to Closure [ Time Frame: Up to four months ]The time it takes for a wound to completely close.
- Duration of wound closure [ Time Frame: Up to four months ]If a closure occurs, the time a wound remains epithelialized after the first, and any subsequent closures.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04214002
|United States, California|
|Redwood City, California, United States, 94063|