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

Trial ID or NCT#

NCT04214002

Status

not recruiting iconNOT RECRUITING

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)

Eligibility Criteria

Ages Eligible for Study: Older than 6 Months
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No
Inclusion Criteria:
  1. * 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:
  1. * In the opinion of the investigator, inclusion poses an unacceptable risk to the patient or interpretation of these study data.

Investigator(s)

M. Peter Marinkovich, MD
M. Peter Marinkovich, MD
Dermatologist, Blistering disease specialist, Psoriasis specialist
Associate Professor of Dermatology