Innovative wound gel reduces frequency of painful dressing changes in epidermolysis bullosa

A post-hoc analysis of the EASE trial revealed that a wound gel with birch extract significantly lowered the frequency of dressing changes in patients with epidermolysis bullosa (EB). Fewer dressing changes not only cause less pain but also save a considerable amount of time for patients and caregivers.

Epidermolysis bullosa is a rare genetic disease characterised by skin fragility and blister formation in response to minimal trauma. As there is no causal treatment, management focuses on demanding wound care with frequent and painful dressing changes.

Previously, the birch bark extract-containing wound gel Oleogel-S10 led to a higher proportion of patients with complete closure of the target wound within 45±7 days in the randomised, double-blind, vehicle-controlled, phase 3 EASE trial (NCT03068780). This was the first trial to demonstrate the clinical benefit of any agent in the rare genetic disease epidermolysis bullosa. Prof. Dimitra Kiritsi (University of Freiburg, Germany) presented the current analysis that aimed to assess the impact of Oleogel-S10 treatment for those patients that are most severely affected, namely those that required daily dressing changes at baseline [1].

The analysis included 46 participants receiving Oleogel-S10 and 53 participants receiving the control gel. “There was no change in daily dressing changes with the control gel, while in the other group, the number of those who did not need daily changes increased and was significantly different from the control at day 45, 60, and 90,” Prof. Kiritsi said. At that time, 35.6% of participants in the intervention arm had a reduced requirement for daily dressing changes compared with 10.6% in the control group. This translates to almost 3 fewer dressing changes every 2 weeks for participants treated with the birch gel.

Prof. Kiritisi emphasised that this difference is a relevant clinical benefit not only for the patient but also for their caregivers. Compared with historical data, the estimated time saved on dressing changes per week for patients in this cohort was 10.9 hours in the intervention group (6.6 hours for each patient and 4.4 hours for their caregiver/assistant) versus 4.0 hours for those applying the control gel (see Figure) [1,2]. “This is important for our patients: this is time they can be doing something nice with their family and not be in pain,” Prof. Kiritsi concluded.

Figure: Time saved on dressing changes for patients and caregivers [1,2]

1. 
   
   1. Kiritsi D, et al. Oleogel-S10 reduces dressing changes burden in patients with epidermolysis bullosa. D3T01.3H, EADV Congress 2023, 11–14 October, Berlin, Germany.
   2. Bruckner AL, et al. Orphanet J Rare Dis 2020;15:1.

 

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Posted on 28 November, 202328 November, 2023