Trial Search Results
The Natural History of Wounds in Patients With Dystrophic Epidermolysis Bullosa (DEB)
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.
Stanford is currently accepting patients for this trial.
Krystal Biotech, Inc.
Collaborator: Stanford University
- 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
- 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.
- In the opinion of the investigator, inclusion poses an unacceptable risk to the
patient or interpretation of these study data.
Ages Eligible for Study
6 Months - N/A
Genders Eligible for Study