Efficacy and Safety Study to Evaluate SD-101 in Epidermolysis Bullosa
ConditionEpidermolysis Bullosa (EB)
Trial statusNot yet recruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age28-12
SponsorParadigm Therapeutics
About this trial
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).
Eligibility criteria
Qualifiers
Informed Consent (ICF) form signed by the patient or patient's legal representative. Since all patients with be 12 years old or younger at study entry, signed assent from the patient's legal representative will be required.
Patient (or caretaker) must be willing to comply with all protocol requirements.
Diagnosis of Simplex, Recessive Dystrophic, or JEB-nH EB.
Patient must have 1 target wound (size 10 to 50 cm2).
Disqualifiers
Patients who do not meet the entry criteria outlined above.
Selected target wound cannot have clinical evidence of local infection.
Use of any investigational drug or approved EB therapy within 30 days before enrollment.
Use of immunotherapy or cytotoxic chemotherapy within 60 days before enrollment.
Trial design
Treatments tested in this trial
- SD-101 Dermal Cream (6%)
- Vehicle (SD-101 0%)
Treatment groups
80 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov