Sermsaksasithorn Pim, Asawanonda Pravit, Phutrakool Phanupong, Ondee Thunnicha, Chariyavilaskul Pajaree, Payungporn Sunchai, Pongpirul Krit, Hirankarn Nattiya
Center of Excellence in Preventive and Integrative Medicine and Department of Preventive and Social Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
Division of Dermatology, Department of Medicine, Faculty of Medicine, Chulalongkorn University, Bangkok, Thailand.
Med Cannabis Cannabinoids. 2024 May 30;7(1):99-110. doi: 10.1159/000539492. eCollection 2024 Jan-Dec.
Current topical treatments for psoriasis offer limited efficacy and are associated with long-term adverse effects in a subset of patients, highlighting the need for new therapeutic options. Cannabidiol (CBD), a non-psychoactive cannabinoid derived from L., has shown potential in reversing psoriasis pathology through its action on skin receptors in preclinical studies. Given the promising properties of CBD, transdermal patches containing this compound represent a novel approach to psoriasis treatment. However, comprehensive data on their efficacy and safety remain scarce.
We outline a randomized, double-blind, placebo-controlled trial to assess the efficacy and safety of CBD transdermal patches with minimal tetrahydrocannabinol (THC) in 60 patients with mild to moderate plaque-type psoriasis at a university hospital in Thailand ( = 60). This study aims to evaluate the changes in the local psoriasis severity index (LPSI), itch score via a visual analog scale, and occurrence of adverse events on day 0, 30, 60, and 90 of the study. Additionally, we will examine the alteration in the skin, gut, and oral microbiome in a subset of participants to explore potential correlations with treatment outcomes. The primary outcome will focus on the difference in LPSI scores at the end of the study period, employing an intention-to-treat analysis. Multivariate logistic regression will be used to identify baseline clinical and microbiological predictors of treatment response.
This study aims to investigate the efficacy and safety of CBD transdermal patches in alleviating the symptoms of psoriasis. The results of this study may highlight a novel topical treatment option that reduces suffering in patients with psoriasis. We also designed to provide a holistic evaluation by considering both clinical outcomes and the underlying biological mechanisms, including the interaction with the human microbiome. Through this trial, we aim to contribute valuable insights into personalized psoriasis management strategies.
目前用于治疗银屑病的局部疗法疗效有限，且在部分患者中会产生长期不良反应，这凸显了对新治疗方案的需求。大麻二酚（CBD）是一种从大麻中提取的无精神活性的大麻素，在临床前研究中已显示出通过作用于皮肤受体来逆转银屑病病理的潜力。鉴于CBD具有良好的特性，含有该化合物的透皮贴剂代表了一种治疗银屑病的新方法。然而，关于其疗效和安全性的全面数据仍然匮乏。
我们概述了一项随机、双盲、安慰剂对照试验，以评估在泰国一家大学医院对60例轻度至中度斑块型银屑病患者使用含最低四氢大麻酚（THC）的CBD透皮贴剂的疗效和安全性（n = 60）。本研究旨在评估研究第0、30、60和90天局部银屑病严重指数（LPSI）的变化、通过视觉模拟量表评估的瘙痒评分以及不良事件的发生情况。此外，我们将在一部分参与者中检查皮肤、肠道和口腔微生物群的变化，以探索与治疗结果的潜在相关性。主要结局将聚焦于研究期末LPSI评分的差异，采用意向性分析。多变量逻辑回归将用于确定治疗反应的基线临床和微生物学预测因素。
本研究旨在调查CBD透皮贴剂缓解银屑病症状的疗效和安全性。本研究结果可能会突出一种减轻银屑病患者痛苦的新型局部治疗选择。我们还旨在通过考虑临床结局和潜在生物学机制，包括与人类微生物群的相互作用，提供全面评估。通过这项试验，我们旨在为个性化银屑病管理策略提供有价值的见解。
