Status:
RECRUITING
Evaluation of D-Fi for the Treatment of Wounds Due to DEB
Lead Sponsor:
Castle Creek Biosciences, LLC.
Collaborating Sponsors:
Prosoft Clinical
Conditions:
Dystrophic Epidermolysis Bullosa
Eligibility:
All Genders
2+ years
Phase:
PHASE3
Brief 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...
Detailed Description
CCB-EB-304 is a multi-center, intra-patient randomized and controlled, open-label, rater-blinded Phase 3 study of D-Fi for the treatment of persistent non-healing and recurrent DEB wounds in approxima...
Eligibility Criteria
Inclusion
- Male or female ≥2 years of age at the Screening visit
- Clinical diagnosis of DEB with confirmation of COL7A1 genetic mutation.
Exclusion
- Medical instability limiting ability to travel to the investigative site.
- Active infection with human immunodeficiency virus, hepatitis B or hepatitis C.
- The presence of COL7 antibodies.
- Evidence of systemic infection.
- Known allergy to any of the constituents of the product.
- Female who is pregnant or breastfeeding.
Key Trial Info
Start Date :
March 27 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 1 2042
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT06892639
Start Date
March 27 2025
End Date
February 1 2042
Last Update
July 28 2025
Active Locations (4)
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1
Stanford University School of Medicine, Dermatology
Redwood City, California, United States, 94063
2
Mission Dermatology
Santa Margarita, California, United States, 92688
3
Children's Hospital Colorado
Aurora, Colorado, United States, 80045
4
University of Massachusetts
Worcester, Massachusetts, United States, 01655