Ignite Creation Date:
2024-05-06 @ 2:05 PM
Last Modification Date:
2024-10-26 @ 1:25 PM
Study NCT ID:
NCT04214002
Status:
WITHDRAWN
Last Update Posted:
2021-09-17
First Post:
2019-12-23
Brief Title:
The Natural History of Wounds in Patients With Dystrophic Epidermolysis Bullosa DEB
Sponsor:
Krystal Biotech Inc
Organization:
Krystal Biotech Inc
Study Overview
Official Title:
A Prospective Study to Evaluate the Natural History of Wounds in Patients With Dystrophic Epidermolysis Bullosa DEB
Status:
WITHDRAWN
Status Verified Date:
2021-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Due to the COVID-19 Pandemic the study was withdrawn
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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
Detailed 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 Biotechs 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
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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None