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
Phase of Trial: Phase III
Latest Information Update: 11 Aug 2017
At a glance
- Drugs Allantoin (Primary)
- Indications Epidermolysis bullosa
- Focus Registrational; Therapeutic Use
- Acronyms ESSENCE
- Sponsors Scioderm
- 03 Aug 2017 Status changed from active, no longer recruiting to completed.
- 19 May 2017 According to an Amicus Therapeutics media release, based on discussions with the Dermatology Division of the U.S. FDA, the endpoint of "time to wound closure within 3 months" will be analyzed first. If the difference between SD-101 6% and placebo is statistically significant (p = 0.05), then the study will be considered a success and later on "proportion of patients with target wound closure at month 3" will be analyzed and considered statistically significant at p = 0.05.
- 18 Apr 2017 Planned primary completion date changed from 1 Jun 2017 to 1 Jul 2017.