Trial reportThe Journal of dermatology2025
Reduction in Dressing Change Burden in Patients With Epidermolysis Bullosa-Impact of Oleogel-S10.
Trial report in The Journal of dermatology, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03068780 (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), which is not on this map. Cited by 2 papers.
What it found
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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
Who cites it
2 citing papers in PubMed.
- Long-Term Efficacy and Safety of Oleogel-S10 (Birch Triterpenes) for Pediatric Patients With Epidermolysis Bullosa.Pediatric dermatologyTrial
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
10 authors.
Funding
Abstract
Epidermolysis bullosa (EB) is a severe genetic disorder marked by skin fragility and blistering from minimal trauma. Management relies on frequent and painful dressing changes. The EASE study (NCT03068780), the largest to date in EB, previously demonstrated accelerated wound healing and reduced wound burden for Oleogel-S10 (birch triterpenes) versus control gel. This post hoc analysis focused on dressing change frequency and related time and cost savings among patients with daily dressing changes at baseline (Oleogel-S10 n = 47, control gel n = 53). By Day 90, 35.6% of Oleogel-S10 patients required fewer daily changes versus 10.6% in the control group (p = 0.005). Weekly dressing changes reduced by 1.36 ± 0.24 with Oleogel-S10 compared to 0.41 ± 0.23 for control (difference -0.95 ± 0.33; p = 0.005). This translated to almost three fewer dressing changes every 2 weeks for Oleogel-S10 versus nearly one change for the control gel. The estimated time saved per week was 10.7 h with Oleogel-S10 (6.4 h patient, 4.3 h caregiver) versus 4.0 h with control (2.4 h patient, 1.6 h caregiver). Estimated dressing costs reduced by 59%, from $63.4 k to $25.9 k per patient over 27 months. Oleogel-S10 significantly reduced dressing frequency and time burden, with potential to ease the intensive demands of EB wound care.
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Registered trials
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