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Due to the COVID-19 Pandemic, the study was withdrawn.
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| Name | Class |
|---|---|
| Stanford University | OTHER |
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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.
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| Measure | Description | Time Frame |
|---|---|---|
| Change in wound surface area | Percent change in wound surface area from baseline will be measured from images uploaded to an imaging application. | Up to four months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Closure | The time it takes for a wound to completely close. | Up to four months |
| Duration of wound closure | If a closure occurs, the time a wound remains epithelialized after the first, and any subsequent closures. |
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Inclusion Criteria:
Exclusion Criteria:
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Patients must be 6 months of age or older, and have a diagnosis of DEB based on genetic analysis or histologic criteria. In addition, patients must have at least 1 wound that is suitable for imaging in investigator's opinion at time of screening.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University | Redwood City | California | 94063 | United States |
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| ID | Term |
|---|---|
| D016108 | Epidermolysis Bullosa Dystrophica |
| ID | Term |
|---|---|
| D004820 | Epidermolysis Bullosa |
| D012868 | Skin Abnormalities |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| Up to four months |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D003095 | Collagen Diseases |
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012871 | Skin Diseases |
| D012872 | Skin Diseases, Vesiculobullous |