NCT04214002

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

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

• Status: Withdrawn
• Phase: —
• Study type: Observational
• Enrollment: 0 (actual)
• Sponsor: Krystal Biotech, Inc. · Industry
• Sex: All
• Age: 6 Months
• Healthy volunteers: Not accepted

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 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.

Conditions

• Dystrophic Epidermolysis Bullosa
• DEB - Dystrophic Epidermolysis Bullosa

Timeline

• Start date: 2020-01-01
• Primary completion: 2020-02-24
• Completion: 2020-02-24
• First posted: 2019-12-30
• Last updated: 2021-09-17

Locations

1 site across 1 country: United States