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

Abstract

ABSTRACTBackgroundExisting topical psoriasis treatments are partially effective or have long-term side effects for a proportion of people with psoriasis; therefore, effective and safe treatment options are required. Cannabidiol, a cannabinoid inCannabis sativa, reverses the etiology of psoriasis through skin receptors according to in vitro research. Cannabidiol transdermal patches may be an effective treatment for psoriasis, although the efficacy and safety data are limited.Methods and analysisThis is a randomized double-blind controlled trial comparing cannabidiol (CBD) with minimal tetrahydrocannabinol (THC) patches with placebo patches (1:1 ratio) daily applied to comparable lesions of each patient with mild to moderate plaque-type psoriasis performed in a university hospital in Thailand (n=60). The primary outcome is the local psoriasis severity index (LPSI). The local severity index of psoriasis, the itch score using the visual analog scale, and adverse events will be evaluated on day 0, 30, 60, and 90 of the study. Furthermore, on days 0 and 90 of this study, biological samples will be taken for the evaluation of the skin, gut, and mouth microbial profile of 50% of randomly selected individuals.ConclusionsThis study aims to investigate the efficacy and safety of cannabidiol transdermal patches in alleviating the symptoms of psoriasis. We will also examine personal impacts on the efficacy and safety of patches, such as the microbial profile. The results of this study may highlight a novel topical treatment option that reduces suffering in patients with psoriasis.Ethics and disseminationThis study was registered with the. The protocol is being considered by the Institutional Review Board of the Faculty of Medicine, Chulalongkorn University. The results of this study will be faithfully presented through conferences or published articles.