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Double-blind, Randomised, Vehicle-controlled, Phase III, Efficacy and Safety Study With 24-month Open-label Follow-up of Oleogel-S10 in Patients With Inherited Epidermolysis Bullosa

Trial Profile

Double-blind, Randomised, Vehicle-controlled, Phase III, Efficacy and Safety Study With 24-month Open-label Follow-up of Oleogel-S10 in Patients With Inherited Epidermolysis Bullosa

Status: Completed
Phase of Trial: Phase III

Latest Information Update: 06 Feb 2024

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At a glance

  • Drugs Birch triterpenes (Primary) ; Birch triterpenes (Primary)
  • Indications Epidermolysis bullosa; Epidermolysis bullosa dystrophica
  • Focus Registrational; Therapeutic Use
  • Acronyms EASE
  • Sponsors Amryt Pharma
  • Most Recent Events

    • 04 Feb 2024 This trial has been completed in Italy, as per European Clinical Trials Database record.
    • 19 Dec 2023 According to an Amryt Pharma media release, company announced that the U.S. Food and Drug Administration (FDA) approved FILSUVEZ (birch triterpenes) topical gel for the treatment of partial thickness wounds in patients 6 months and older with Junctional Epidermolysis Bullosa (JEB) and Dystrophic Epidermolysis Bullosa (DEB).
    • 23 Jan 2023 Results published in the British Journal of Dermatology
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