Clinical Research
Epidermolysis bullosa (EB) is a severe genetic disorder affecting epithelial integrity, primarily managed through frequent wound dressing changes. The EASE study demonstrated accelerated wound healing for Oleogel-S10 (birch triterpenes)* in EB (NCT03068780). This analysis evaluated the impact of Oleogel-S10 on dressing change frequency, time spent and associated costs in patients requiring daily dressing changes at baseline.
EASE enrolled 223 patients with dystrophic or junctional EB randomized to receive Oleogel-S10 (n=109) or control gel (n=114) with standard dressings. Here, a post hoc analysis focused on patients with daily dressing changes at baseline and, using historical data, time spent and saved on dressing changes was calculated.
Among the subset of patients with daily dressing changes at baseline (Oleogel-S10 n=47, control gel n=53), 35.6% receiving Oleogel-S10 experienced reduced requirements by Day 90, compared to 10.6% receiving control gel. Oleogel-S10 resulted in a mean reduction of 1.36±0.24 weekly dressing changes, significantly more than control gel (0.41±0.23 fewer; difference –0.95±0.33; p=0.005). This translated to almost three fewer dressing changes every two weeks for Oleogel-S10 versus nearly one change for the control gel. Estimated time saved on dressing changes per week for the daily change cohort was 10.9h for Oleogel-S10 (6.6h for patients and 4.4h for caregivers) versus 4.0h for the control gel (2.4h for patients and 1.6h for caregivers), with a trend to cost savings in favor of Oleogel-S10.
Oleogel-S10 significantly reduced dressing change frequency compared with control gel, potentially alleviating the burden of dressing changes and associated costs.