Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Krystal Biotech, Inc.
Age
0–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Willing and able to give consent/assent
Clinical diagnosis of epidermolysis bullosa
Confirmation of diagnosis (either DDEB or RDEB) by genetic testing including COL7A1.
Age: 2 months of age and older at the time of informed consent/assent
Women of childbearing age must be willing to use reliable birth control method throughout the treatment duration and for 3 months following the last treatment application
You may not be if
Diseases or conditions that could interfere with the assessment of safety of the study treatment and compliance of the participant with study visits/procedures, as determined by the Investigator
Pregnant or nursing women
Active infection in the area that will undergo administration, that the Investigator believes will negatively impact the IP application
Known allergy to any of the constituents of the product
Concurrent skin transplant or mesh skin grafting; if the participant is currently having transplantation or grafting surgeries they must wait until the transplant has begun to heal and the graft has absorbed prior to initiating B-VEC therapy
Participation in an interventional gene therapy clinical trial within the past three (3) months (not including B-VEC administration)
Clareo Health | A Long-term Treatment With B-VEC for Dystrophic Epidermolysis Bullosa
