Clinical Research Directory
Browse clinical research sites, groups, and studies.
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
2026-07-21
Completion Date
2027-06-17
Last Updated
2026-09-04
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.
Locations (3)
Mission Dermatology
Rancho Santa Margarita, California, United States
Stanford University School of Medicine Dermatology Department
Redwood City, California, United States
Medical University of South Carolina Department of Dermatology and Dermatologic Surgery
Charleston, South Carolina, United States