A randomised, intra-individual controlled trial of the cutaneous healing properties of petrolatum versus the vehicle for Oleogel-S10 when applied topically to mechanically induced partial thickness wounds in healthy volunteers

开始日期2020-09-29

申办/合作机构

Amryt Research Ltd.

EUCTR2019-002081-12-DE

/ Not yet recruiting临床2期

An exploratory randomized, intra-individual controlled trialof the cutaneous healing properties of Petrolatum versus thevehicle for Oleogel-S10 versus no treatment when appliedtopically to mechanically induced partial thickness woundsin healthy volunteers

开始日期2019-12-19

申办/合作机构

Amryt Research Ltd.

RBR-4vz9c4

/ Not yet recruiting临床3期IIT

Double-blind, Randomised, Vehicle-controlled, Phase III, Efficacyand Safety Study with 24-month Open-label Follow-up of Oleogel-S10 in Patients with Inherited Epidermolysis Bullosa

开始日期2018-03-01

申办/合作机构

Amryt Research Ltd.

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2023-06-26·British Journal of Dermatology

BG04 Oleogel-S10 (birch triterpenes) in the treatment of epidermolysis bullosa wounds: 24-month efficacy and safety data from the EASE study

作者: Sprecher, Eli ; Kiritsi, Dimitra ; Maher, Laura ; Kern, Johannes S. ; L. Bruckner, Anna ; Murrell, Dedee ; Cunningham, Tracy

AbstractEpidermolysis bullosa (EB) is a rare debilitating disorder characterized by skin fragility, blister formation and impaired wound healing. The abnormal wound healing seen in EB is a key driver for systemic disease and can lead to serious clinical complications, deformities and symptoms with a devastating impact on quality of life (QoL). The 90-day double-blind phase (DBP) of the phase III EASE study previously demonstrated accelerated wound healing for oleogel-S10 (birch triterpenes) vs. control gel in EB. Here, we report the safety and total wound burden results from the 24-month open-label phase (OLP), in which all patients received treatment with oleogel-S10. EB Disease Activity and Scarring Index (EBDASI) and body surface area percentage (BSAP) data are reported without visit windows to reflect a real-world situation more accurately, particularly considering the COVID-19 pandemic. The patient population was made up of those with dystrophic EB (n = 178; 86.8%) and junctional EB (n = 25; 12.2%). Further baseline characteristics are available in Table 1. In total, 141 patients (68.8%) completed the OLP. The mean (SD) treatment duration for all patients was 584.7 (246.1) days. Adverse events were reported in 77.1% of all patients in the OLP vs. 81.7% of those receiving oleogel-S10 in the DBP. Mean BSAP for patients treated with oleogel-S10 in the DBP reduced from 12.1% at study entry to 6.1% on completion of the EASE study. Similarly, the mean EBDASI skin activity score in the oleogel-S10 group improved from 19.6 to 15.1 at the end of the OLP. In addition, reductions in both BSAP and EBDASI from OLP baseline were observed in patients who transitioned from control gel to oleogel-S10 in the OLP. Oleogel-S10 has a reassuring long-term safety profile. Furthermore, the long-term impact of accelerated wound healing is evident through the sustained reduction in wound burden over time. This is encouraging given the regular reoccurrence of patients’ fragile wounds in the natural course of this chronic disease. Table 1Baseline characteristics

2023-01-23·British Journal of Dermatology

Efficacy and safety of Oleogel-S10 (birch triterpenes) for epidermolysis bullosa: results from the phase III randomized double-blind phase of the EASE study

Article

作者: Fernandez, Maria Florencia ; Cunningham, Tracy ; Murrell, Dédée F ; Schauer, Franziska ; Sumeray, Mark ; Löwe, Sandra ; Kern, Johannes S ; Sprecher, Eli ; Bruckner, Anna L ; Bodemer, Christine ; Davis, Charles

AbstractBackgroundEpidermolysis bullosa (EB) is a heterogeneous group of rare, difficult-to-treat, inherited multisystem diseases affecting epithelial integrity. Patients with EB are affected by mechanical fragility of epithelial surfaces including the skin and, as a result, extensive recurrent blistering is a characteristic of the condition. Chronic wounds predispose patients with EB to the development of squamous cell carcinoma, which is a major cause of premature death.ObjectivesEASE was a double-blind, randomized, vehicle-controlled, phase III study to determine the efficacy and safety of the topical gel Oleogel-S10 (birch triterpenes) in EB. EASE was funded by Amryt Research Limited.MethodsPatients with dystrophic EB, junctional EB or Kindler EB and a target partial-thickness wound lasting ≥ 21 days and < 9 months that was 10–50 cm2, were enrolled and randomized via computer-generated allocation tables 1 : 1 to Oleogel-S10 or control gel – both with standard-of-care dressings. Study gel was applied to all wounds at least every 4 days. The primary endpoint was the proportion of patients with first complete closure of target wound within 45 days.ResultsA total of 223 patients were enrolled and treated (109 treated with Oleogel-S10, 114 with control gel). The primary endpoint was met; Oleogel-S10 resulted in 41·3% of patients with first complete target wound closure within 45 days, compared with 28·9% in the control gel arm (relative risk 1·44, 95% confidence interval (CI) 1·01–2·05; P = 0·013). Adverse events (AEs) occurred with similar frequency for Oleogel-S10 (81·7%) compared with control gel (80·7%). AEs were predominantly of mild-to-moderate intensity (4·6% were severe).ConclusionsOleogel-S10 is the first therapy to demonstrate accelerated wound healing in EB. Oleogel-S10 was well tolerated.

British Journal of Dermatology

Long-term safety and efficacy of Oleogel-S10 (birch bark extract) in epidermolysis bullosa: 24-month results from the phase III EASE study

Article

作者: Murrell, Dédée F ; Torres-Pradilla, Mauricio ; Davis, Charles ; Kiritsi, Dimitra ; Kern, Johannes S ; Cunningham, Tracy ; Fernández, Mariá Florencia ; Bodemer, Christine ; Maher, Laura ; Bruckner, Anna L ; Sprecher, Eli

AbstractBackgroundEpidermolysis bullosa (EB) is a group of rare and severe genetic disorders characterized by persistent skin fragility and open wounds. EB manifests as cutaneous and mucosal blistering, erosions and impaired wound healing.ObjectivesTo determine the long-term efficacy, tolerability and safety of Oleogel-S10 (birch bark extract) in dystrophic EB (DEB) and junctional EB (JEB) in the 24-month open-label phase (OLP) of the EASE study.MethodsEASE was a double-blind randomized controlled phase III study consisting of two phases: a 90-day double-blind phase (DBP) and a 24-month OLP. Patients from both former treatment groups in the DBP entered the single-arm OLP (n = 205). Patients received Oleogel-S10 on all partial-thickness EB wounds. OLP endpoints included the incidence and severity/relatedness of adverse events (AEs), maximum wound infection severity, changes in body surface area percentage (BSAP) of wounds, EB Disease Activity and Scarring Index (EBDASI), pain, itch, disease severity and quality-of-life outcomes.ResultsThe OLP data demonstrated that Oleogel-S10 target wound treatment adherence was > 99% and mean (SD) treatment duration was 584.7 (246.1 days). Seventy-two per cent of patients in the OLP were aged < 18 years and 86.8% had DEB; recessive DEB predominated (78.0%). AEs were reported in 77.1% of patients and were typically mild-to-moderate in severity. Severe and serious AEs were seen in 18.0% and 24.4% of patients, respectively. AEs resulted in the withdrawal of 7.8% of patients (n = 16), including three with treatment-related AEs. Nine deaths were reported; none were attributable to the treatment. The incidence of target wound infections was low (n = 7); five were mild-to-moderate in severity and two were severe. In patients treated with Oleogel-S10 throughout, mean (SD) BSAP changes from DBP baseline at 3, 12 and 24 months were −4.3% (8.1) (P < 0.001), −5.9% (8.6) (P < 0.001) and −3.7% (9.0) (P = 0.003), respectively. Similarly, significant changes in EBDASI skin activity score from DBP baseline were observed: −3.9 (8.3) (P < 0.001), −5.1 (8.2) (P < 0.001) and −3.0 (8.3) (P = 0.007) at 3, 12 and 24 months, respectively.ConclusionsThese data support an encouraging long-term safety profile of Oleogel-S10 and a sustained reduction in wound burden over at least 24 months of Oleogel-S10 treatment.

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