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.
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Investigator(s)

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

View on ClinicalTrials.gov