A suction blister model to characterize epidermal wound healing and evaluate the efficacy of the topical wound healing agent INM-755 in healthy volunteers

IF 4.3 3区 医学 Q1 PHARMACOLOGY & PHARMACY European Journal of Pharmaceutical Sciences Pub Date : 2024-07-29 DOI:10.1016/j.ejps.2024.106867
Wouter ten Voorde , Selinde Wind , Ismahaan Abdisalaam , Alexandra Mancini , Feeke Linders , Manon A.A Jansen , Tessa Niemeyer-van der Kolk , Jacobus Burggraaf , Robert Rissmann
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Abstract

Non-healing wounds represent a substantial medical burden with few effective treatments available. To address this challenge, we developed a novel epidermal wound healing model using suction blisters in healthy volunteers. This model allowed for the comprehensive assessment of wound healing dynamics and the evaluation of INM-755, a topical cream containing cannabinol, as a potential therapeutic agent.
Two clinical studies were conducted: an observational study and an interventional study. In both studies, healthy volunteers underwent a suction blister procedure on their lower back, creating open epidermal wounds. Wound healing parameters were assessed using advanced imaging systems. Skin barrier function and perfusion were evaluated through trans epidermal water loss (TEWL) and dynamic optical coherence tomography (D-OCT), respectively.
The observational study demonstrated the successful and reproducible induction of blisters and the removal of epidermal sheet, enabling quantifiable measurements of wound healing parameters over time. Re-epithelialization was observed, revealing recovery of skin barrier function and perfusion. In the interventional study, differences of treatments over time were quantified using the above-described techniques.
Despite differences from disease-specific blistering, our developed model provides a valuable platform for studying wound healing mechanisms and assessing novel therapeutic interventions. The sensitivity to treatment effects demonstrated in our study underscores the potential utility of this model in early-phase clinical drug development programs targeting wound healing disorders.

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在健康志愿者中使用抽吸水疱模型来描述表皮伤口愈合的特征,并评估外用伤口愈合剂 inm-755 的疗效。
伤口不愈合是一个沉重的医疗负担,而有效的治疗方法却寥寥无几。为了应对这一挑战,我们利用健康志愿者身上的抽吸水泡开发了一种新型表皮伤口愈合模型。通过该模型,我们可以对伤口愈合动态进行全面评估,并对含有大麻酚的外用药膏 INM-755 作为潜在治疗药物进行评估。我们进行了两项临床研究:观察研究和干预研究。在这两项研究中,健康志愿者都在下背部接受了吸疱手术,形成了开放性表皮伤口。使用先进的成像系统对伤口愈合参数进行评估。皮肤屏障功能和灌注分别通过经表皮失水(TEWL)和动态光学相干断层扫描(D-OCT)进行评估。这项观察性研究表明,诱导水泡和去除表皮薄片的过程是成功的、可重复的,从而可以对伤口愈合参数随时间的变化进行量化测量。观察到伤口重新上皮,表明皮肤屏障功能和灌注恢复。在介入性研究中,使用上述技术对不同时间段的治疗差异进行了量化。尽管与疾病特异性水疱不同,但我们开发的模型为研究伤口愈合机制和评估新型治疗干预措施提供了一个宝贵的平台。我们的研究对治疗效果的敏感性强调了该模型在针对伤口愈合疾病的早期临床药物开发项目中的潜在作用。
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来源期刊
CiteScore
9.60
自引率
2.20%
发文量
248
审稿时长
50 days
期刊介绍: The journal publishes research articles, review articles and scientific commentaries on all aspects of the pharmaceutical sciences with emphasis on conceptual novelty and scientific quality. The Editors welcome articles in this multidisciplinary field, with a focus on topics relevant for drug discovery and development. More specifically, the Journal publishes reports on medicinal chemistry, pharmacology, drug absorption and metabolism, pharmacokinetics and pharmacodynamics, pharmaceutical and biomedical analysis, drug delivery (including gene delivery), drug targeting, pharmaceutical technology, pharmaceutical biotechnology and clinical drug evaluation. The journal will typically not give priority to manuscripts focusing primarily on organic synthesis, natural products, adaptation of analytical approaches, or discussions pertaining to drug policy making. Scientific commentaries and review articles are generally by invitation only or by consent of the Editors. Proceedings of scientific meetings may be published as special issues or supplements to the Journal.
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