Active — Not RecruitingPhase 3

Evaluation of D-Fi for the Treatment of Wounds Due to DEB

United States32 participantsStarted 2025-03-27

Plain-language summary

The purpose of this study is to determine whether administration of D-Fi in addition to standard of care improves wound healing as compared to standard of care alone (control) in children, adolescents, and adults with Dystrophic Epidermolysis Bullosa.

Who can participate

Age range2 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

The difference in Complete (100%) Wound Closure of the Target Wound Pair at either Week 22 (Visit 6), and Week 24 (Visit 7) or at Week 24 (Visit 7) and Week 26 (Visit 8) as assessed by a Blinded Assessor.

Timeframe: Week 26

Trial details

NCT IDNCT06892639

SponsorCastle Creek Biosciences, LLC.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2027-09

View on ClinicalTrials.gov More Dystrophic Epidermolysis Bullosa trials