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Efficacy and Safety Study to Evaluate SD-101 in Epidermolysis Bullosa
Sponsor: Paradigm Therapeutics
Summary
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).
Official title: A Phase 3, Multi-center, Randomized, Double-Blind, Placebo Controlled Study of the Efficacy and Safety of SD-101 Cream in Patients With Epidermolysis Bullosa
Key Details
Gender
All
Age Range
28 Days - 12 Years
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2026-05-15
Completion Date
2027-06-17
Last Updated
2026-03-20
Healthy Volunteers
No
Conditions
Interventions
SD-101 Dermal Cream (6%)
SD-101 is a white, crystalline powder that is formulated within an odorless, soft, white cream base. SD-101-6.0 cream contains allantoin, a diureide glyoxylic acid, at a concentration of 6% and other excipients.
Vehicle (SD-101 0%)
A white, crystalline powder that is formulated within an odorless, soft, white cream base. It contains no allantoin, only excipients.