Efficacy and Safety Study to Evaluate SD-101 in Epidermolysis Bullosa
Condition(s) studied
Investigational drug(s) / intervention(s)
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.
Study 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).
Eligibility
Primary outcome measure(s)
- Target wound closure — 1 month
The primary endpoint is the proportion of patients in each treatment group who experience complete closure of their target wound by Month 1 on study. Complete target wound closure is defined as skin re-epithelialization without drainage.
Trial sites (4)
| Facility | City | Region | Status |
|---|---|---|---|
| Mission Dermatology | Rancho Santa Margarita | California | Recruiting |
| Stanford University School of Medicine Dermatology Department | Redwood City | California | Recruiting |
| Children's Hospital of Philadelphia | Philadelphia | Pennsylvania | Recruiting |
| Medical University of South Carolina Department of Dermatology and Dermatologic Surgery | Charleston | South Carolina | Recruiting |
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07482787 on ClinicalTrials.gov ↗ ← All trials in the USA