Status: Not yet recruiting
Efficacy and Safety Study to Evaluate SD-101 in Epidermolysis Bullosa
The upcoming trial is for EB patients is a topically applied whole-body treatment of patients with either Simplex, RDEB or Junctional (nH) ages 1 month to 12 years old at study entry. There are only 4 site visits by patients with minimal assessments over a 2-month period, and patients completing this study will have the ability to continue receiving SD-101-6.0 at home in an open-label extension study. The drug product and placebo require no special preparation or storage conditions (room temperature).
Participants needed: 80
Trial details
Phase: Phase 3Age: 28-12Biological sex: AllType: InterventionalSponsor: Paradigm TherapeuticsUpdated: Mar 20, 2026
Eligibility criteria
Informed Consent (ICF) form signed by the patient or patient's legal representat... [+6]
Patients who do not meet the entry criteria outlined above. [+10]