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

Trial Profile

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

Completed
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
  • Most Recent Events

    • 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.
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