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This study evaluates a product called D-Fi for the treatment of wounds caused by dystrophic epidermolysis bullosa (DEB). People aged 2 and older with DEB confirmed by a COL7A1 genetic mutation can take part. It is a Phase 3 study; it is active, not recruiting.
The summary above is a plain-language rendering of the official record. The original English title is shown for reference.
Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine eligibility.
Inclusion Criteria: * Male or female ≥2 years of age at the Screening visit * Clinical diagnosis of DEB with confirmation of COL7A1 genetic mutation. Exclusion Criteria: * Medical instability limiting ability to travel to the investigative site. * Active infection with human immunodeficiency virus, hepatitis B or hepatitis C. * The presence of clinically significant COL7 antibodies. * Evidence of systemic infection. * Known allergy to any of the constituents of the product. * Female who is pregnant or breastfeeding.