Efficacy and Safety of Cannabis Transdermal Patch for Alleviating Psoriasis Symptoms: Protocol for a Randomized Controlled Trial (CanPatch).

Introduction: 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 Cannabis sativa 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. Methods: 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 (n = 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. Conclusion: 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.

Cannabis and cannabinoids in dermatology: protocol for a systematic review and meta-analysis of quantitative outcomes.

INTRODUCTION: Following the discovery of various effects on skin function by modifying endocannabinoid systems, multiple preclinical studies have revealed the promise of cannabis and cannabinoids in the treatment of a variety of skin diseases. However, its clinical efficacy is still debated. METHODS AND ANALYSIS: The protocol has been prepared using the Preferred Items for Systematic Review and Meta-analysis Protocols guidelines. A systematic search will be conducted using PubMed, EMBASE, SCOPUS, the Cochrane Central Register of Controlled Trials and Web of Science. We will include randomised controlled trials and observational studies investigating alterations to dermatological characteristics following administration of cannabis and cannabinoids for dermatological diseases and disorders. The two reviewers will perform both the title and abstract and full-text screenings. The Cochrane Risk-of-Bias 2 and ROBINS-1 tools will be used to evaluate the risk of bias. If a group of comparable studies for each quantitative outcome can be discovered, we will conduct a random effects meta-analysis. We will investigate heterogeneity using a combination of visual inspection of the forest plot, the Cochran's Q test and Higgins' test [I2]. Sensitivity analyses will be performed to assess the statistical robustness of the primary outcome. To evaluate a publication bias, the Egger's regression asymmetry test and funnel plots will be considered. ETHICS AND DISSEMINATION: This study does not require ethical approval because no original data will be collected. The findings will be presented at conferences and published in peer-reviewed journals. PROSPERO REGISTRATION NUMBER: CRD42023397189.

On and off-label uses of interleukin-17 inhibitors for patients with plaque-type psoriasis in Thailand: a real-world study.

BACKGROUND: Off-label uses of biologics in the treatment of psoriasis are usually implemented in limited-resource settings and studies regarding their response profiles are limited. METHOD: This was a retrospective study performed in moderate-to-severe plaque-type psoriasis patients who had been treated with either secukinumab, ixekizumab or brodalumab at a university hospital in Thailand between 1 January 2017 and 1 April 2021. RESULTS: A total of 142 patients were included in the data analysis consisting of three groups of 48 patients, 86 patients, and 8 patients treated by secukinumab, ixekizumab, and brodalumab, respectively. Patients were then classified into five groups according to the dosing pattern they received; on-label, off-label with induction, off-label with specific pattern, off-label with irregular dosing interval <8 weeks and >8 weeks. Considering both secukinumab and ixekizumab, the adjusted hazard ratios (95%CI) for complete skin clearance of the four off-label regimens were 2.2(0.9-5.2), 1.9 (0.9-3.9), 1.0 (0.4-2.2), and 1.6 (0.7-3.6), compared to on-label regimen, respectively. In each biologic drug, almost all off-label dosing regimens demonstrated higher adjusted hazard ratios compared to on-label regimen. CONCLUSION: Off-label, patient-oriented regimens could be a promising choice of IL-17 inhibitors for administration in special settings. Off-label regimens are not inferior in terms of skin clearance to an on-label regimen in the efficacy of psoriasis treatment of secukinumab and ixekizumab but do cause more flares. The decision to use off-label regimens must account for the benefits and associated risks.