Efficacy and safety of Oleogel-S10 (birch triterpenes) for epidermolysis bullosa: results from the phase III randomized double-blind phase of the EASE study

Epidermolysis bullosa (EB) is a heterogeneous group of rare, difficult-to-treat, inherited multisystem diseases affecting epithelial integrity. Patients with EB are affected by mechanical fragility of epithelial surfaces including the skin and, as a result, extensive recurrent blistering is a charac...

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Bibliographic Details
Published in:British journal of dermatology (1951) 2023-01, Vol.188 (1), p.12-21
Main Authors: Kern, Johannes S, Sprecher, Eli, Fernandez, Maria Florencia, Schauer, Franziska, Bodemer, Christine, Cunningham, Tracy, Löwe, Sandra, Davis, Charles, Sumeray, Mark, Bruckner, Anna L, Murrell, Dédée F
Format: Article
Language:English
Subjects:
Betula
Double-Blind Method
Epidermolysis Bullosa
Epidermolysis Bullosa Dystrophica
Humans
Triterpenes
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Summary:Epidermolysis bullosa (EB) is a heterogeneous group of rare, difficult-to-treat, inherited multisystem diseases affecting epithelial integrity. Patients with EB are affected by mechanical fragility of epithelial surfaces including the skin and, as a result, extensive recurrent blistering is a characteristic of the condition. Chronic wounds predispose patients with EB to the development of squamous cell carcinoma, which is a major cause of premature death. EASE was a double-blind, randomized, vehicle-controlled, phase III study to determine the efficacy and safety of the topical gel Oleogel-S10 (birch triterpenes) in EB. EASE was funded by Amryt Research Limited. Patients with dystrophic EB, junctional EB or Kindler EB and a target partial-thickness wound lasting ≥ 21 days and
ISSN:0007-0963
1365-2133
DOI:10.1093/bjd/ljac001