D-Fi for Epidermolysis Bullosa
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Do I need to stop my current medications for the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.
How does the drug D-Fi differ from other treatments for epidermolysis bullosa?
D-Fi is unique because it targets the underlying genetic cause of recessive dystrophic epidermolysis bullosa (RDEB), which is a lack of type VII collagen, a protein crucial for skin integrity. Unlike other treatments that mainly address symptoms, D-Fi aims to address the root cause of the disease, potentially offering a more effective solution.12345
Are You a Good Fit for This Trial?
This trial is for children and adults aged 2 years or older with a clinical diagnosis of Recessive Dystrophic Epidermolysis Bullosa (RDEB) confirmed by COL7A1 genetic mutation. It's not suitable for those who are medically unstable, have certain infections like HIV or hepatitis, are allergic to the product's ingredients, have COL7 antibodies, systemic infections, or if they're pregnant or breastfeeding.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive intradermal injections of D-Fi in treatment wounds during multiple sessions
Follow-up
Participants are monitored for safety and effectiveness after treatment
Long-term safety follow-up
Long-term safety follow-up for subjects who received D-Fi injections
What Are the Treatments Tested in This Trial?
Interventions
- D-Fi
Find a Clinic Near You
Who Is Running the Clinical Trial?
Castle Creek Biosciences, LLC.
Lead Sponsor
Prosoft Clinical
Collaborator