Evidence map›Paper›PMID 40908727›Full record

Trial reportThe Journal of dermatology2025

Reduction in Dressing Change Burden in Patients With Epidermolysis Bullosa-Impact of Oleogel-S10.

Anna L Bruckner, Dédée Murrell, Lara Wine Lee, Eli Sprecher, Dimitra Kiritsi, Laura Maher, Sandra Löwe, Maryanne Donovan, Johannes S Kern, EASE investigators

Registry-linked trialAbstract readClinical Trial, Phase IIIMulticenter StudyRandomized Controlled Trial
In one paragraph

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.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

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.

2 · The registry

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.

NCT03068780 phase3completednot on this map

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

TypeinterventionalSponsorAmryt Research LimitedRan2017 to 2022Enrolled223ConditionsEpidermolysis BullosaArmsOleogel-S10, Control gel
3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Trial
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

10 authors.

Anna L BrucknerDepartment of Dermatology, University of Colorado School of Medicine, Aurora, Colorado, USA.
Dédée MurrellDepartment of Dermatology, St. George Hospital, University of new South Wales, Sydney, New South Wales, Australia.ORCID https://orcid.org/0000-0003-2971-0199
Lara Wine LeeDepartment of Dermatology and Dermatologic Surgery, Medical University of South Carolina, Charleston, South Carolina, USA.ORCID https://orcid.org/0000-0002-4175-316X
Eli SprecherThe Tel Aviv Sourasky Medical Center, Gray Faculty of Medicine and Health Sciences, Tel Aviv University, Tel Aviv, Israel.ORCID https://orcid.org/0000-0002-4093-1032
Dimitra KiritsiDepartment of Dermatology, Faculty of Medicine, Medical Center, University of Freiburg, Freiburg, Germany.
Laura MaherAmryt Research Limited, Dublin, Ireland.
Sandra LöweChiesi GRD, Dublin, Ireland.
Maryanne DonovanChiesi GRD, Dublin, Ireland.
Johannes S KernDepartment of Dermatology, Alfred Hospital, School of Translational Medicine, Monash University, Melbourne, Australia.
EASE investigators

Funding

Amryt Research Ltd
6 · The paper itself

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.

Indexed as

BandagesEpidermolysis BullosaOrganic ChemicalsAdolescentAdultCost SavingsFemaleHumansMaleMiddle AgedTreatment OutcomeWound HealingYoung AdultoleogelsOrganic Chemicals

Identifiers

PMID40908727
PMCPMC12411827

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.