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The Natural History of Wounds in Patients With Dystrophic Epidermolysis Bullosa (DEB)
Not Recruiting
Trial ID: NCT04214002
Purpose
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.
Official Title
A Prospective Study to Evaluate the Natural History of Wounds in Patients With Dystrophic Epidermolysis Bullosa (DEB)
Stanford Investigator(s)
M. Peter Marinkovich, MD
Associate Professor of Dermatology
Eligibility
Inclusion Criteria:
- Written informed consent is provided. Patients 18 years of age and older, and
parent(s)/legal guardian(s) of patients younger than 18 years of age, must provide
written informed consent prior to participating in the study; additionally, informed
assent will be obtained from patients younger than 18 years of age as specified by
local requirements.
- Patient must have a documented diagnosis of DEB based on genetic analysis showing a
mutation in COL7A1 or, in the opinion of the investigator, a confirmed diagnosis of
DEB based on histologic criteria (antigen mapping or electron microscopy).
- Age: 6 months and older
- Patient must have at least 1 wound that is suitable for imaging, in the opinion of the
investigator, at the time of enrollment.
- Patient is willing and able to undergo the protocol-specified procedures.
Exclusion Criteria:
- In the opinion of the investigator, inclusion poses an unacceptable risk to the
patient or interpretation of these study data.
Not Recruiting
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305