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.

Lead Sponsor:

Krystal Biotech, Inc.

Collaborator: Stanford University

Stanford Investigator(s):

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.

Ages Eligible for Study

6 Months - N/A

Genders Eligible for Study

All

Now accepting new patients

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting