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Epidermolysis bullosa: Novel wound treatment on the horizon

Presented by
Prof. Dedee F. Murrell, St George Hospital, University of New South Wales, Australia
EADV 2020
Phase 3
Oleogel-S10 has shown great promise as a topical treatment for epidermolysis bullosa. In a multicentre, phase 3 study, complete wound closure was reached by 41.3% of wounds treated with Oleogel-S10 versus 28.9% of those treated with a control gel.

“Epidermolysis bullosa [EB] is a chronic genetic skin fragility disorder characterised by the presence of recurring healing and breaking down of wounds as well as chronic wounds,” Prof. Dedee F. Murrell (St George Hospital, University of New South Wales, Australia) told the audience [1]. A specific treatment for EB has been lacking, and the standard of care until now comprised non-adhesive bandages and topical treatments (i.e. anti-microbials, corticosteroids).

The agent that is expected to address this need for a specific treatment is Oleogel-S10. Oleogel-S10 is derived from the bark of the birch tree. It consists of 10% dry extract from this bark with 90% of pure sunflower oil and can be applied directly to the open wound during dressing changes at least every 4 days [2,3].

The phase 3 EASE trial (NCT03068780) enrolled 252 patients from 58 sites in 28 countries [1]. The target wound had to be a partial-thickness wound aged ≥21 days and <9 months; median wound age was 35.5 days. The age of participants ranged from 21 days to adults, with about 70% being under 18 years; 60.1% were male and 51.6% underweight, which can be expected in EB patients according to Prof. Murrell. The majority of study subjects (78.5%) suffered from recessive dystrophic EB. Participants underwent a stratified randomisation to consider the different subtypes of EB. The double-blind treatment with either Oleogel-S10 or a sunflower oil gel as vehicle gel (1:1), both with standard-of-care, lasted 90±7 days and was continued in an open-label extension. The primary endpoint was complete wound closure rate within 45 days.

Complete wound closure was achieved by 41.3% of the target wounds in the Oleogel-S10 group versus 28.9% of wounds in the vehicle gel group (P=0.013). “This is the first time that a phase 3 trial in EB has met its primary endpoint,” Prof. Murrell pointed out. Looking at the subgroups, she explained that the treatment benefit was driven by the acceleration in the group with recessive dystrophic EB. This subtype had the greatest benefit with the difference between Oleogel-S10 and vehicle gel reaching high statistical significance (P=0.008). “The wound healing trajectories demonstrate that Oleogel-S10 accelerates wound healing in a subset of wounds; however, as expected with good wound care, the vehicle group began to catch up later by 90 days,” said Prof. Murrell. She added that the control arm never overtook the Oleogel-S10 arm.

Looking at itch reduction in the age group 4–13 years, an overall improvement was observed but the control group had better results than the Oleogel S-10 group. In terms of pain during the changing of dressing, Oleogel-S10 outperformed the vehicle gel in a statistically significant manner at day 14 but not at day 90. Prof. Murrell thought this result was probably influenced by the small sample size.

In general, 81.2% of the patients had some sort of adverse event (80.7% Oleogel-S10; 80.7% vehicle gel), mostly mild and moderate. “A low number of target wound infections occurred. Only 8 overall, 5 patients had target wound infections reported as adverse events, with 4 of these occurring in the control group,” Prof. Murrell informed.

In conclusion, she saw Oleogel-S10 as a well-tolerated and potentially important advancement for patients and their families, especially in recessive dystrophic EB.

    1. Murrell DF, et al. Efficacy and safety of Oleogel-S10 for epidermolysis bullosa – results of 3 months double-blind treatment during the phase 3 study ‘EASE’. D3T03.3B, EADV 2020 Virtual Congress, 29-31 Oct.
    2. Grysko M, Daniels R. 2013;68:572-7.
    3. Schwieger-Briel A, et al. Dermatol Res Pract. 2017;2017:5068969.

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