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The Natural History of Wounds in Patients With Dystrophic Epidermolysis Bullosa (DEB)

Dystrophic Epidermolysis Bullosa Clinical Trial

Official title:
A Prospective Study to Evaluate the Natural History of Wounds in Patients With Dystrophic Epidermolysis Bullosa (DEB)

Clinical Trial Summary

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.

Clinical Trial Description

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 Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04214002
Study type Observational
Source Krystal Biotech, Inc.
Contact
Status Withdrawn
Phase
Start date January 2020
Completion date February 24, 2020
View Details
See also
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