Department of Dermatology, Henry Ford Health System, Detroit, MI, USA.
Dermatology, University of Colorado, Aurora, CO, USA.
Clin Exp Dermatol. 2021 Dec;46(8):1518-1529. doi: 10.1111/ced.14749. Epub 2021 Aug 31.
An increasing number of studies have investigated the adverse effect profile of oral cannabinoids; however, few studies have provided sufficient data on the tolerability of topical cannabinoids in human participants.
To assess the tolerability profile of several commercial topical formulations containing cannabidiol (CBD) and palmitoylethanolamide (PEA) on the skin of healthy human participants.
Three human clinical trials and one in vitro study were conducted. The potential for skin irritation, sensitization and phototoxicity of several products, were assessed via patch testing on healthy human skin. The products assessed included two formulations containing CBD and PEA, one containing hemp seed oil and four concentrations of CBD alone. Ocular toxicity was tested using a traditional hen's egg chorioallantoic membrane model with three CBD, PEA and hemp seed oil formulations.
There was no irritation or sensitization of the products evident via patch testing on healthy participants. Additionally, mild phototoxicity of a hemp seed oil product was found at the 48-h time point compared with the negative control. The in vitro experiment demonstrated comparable effects of cannabinoid products with historically nonirritating products.
These specific formulations of CBD- and PEA-containing products are nonirritating and nonsensitizing in healthy adults, and further encourage similar research assessing their long-term safety and efficacy in human participants with dermatological diseases. There are some limitations to the study: (i) external validity may be limited as formulations from a single manufacturer were used for this study, while vast heterogeneity exists across unregulated, commercial CBD products on the market; and (ii) products were assessed only on normal, nondiseased human skin, and therefore extrapolation to those with dermatological diseases cannot be assumed.
越来越多的研究调查了口服大麻素的不良反应概况；然而，很少有研究提供足够的数据来证明人类参与者对局部大麻素的耐受性。
评估几种含有大麻二酚（CBD）和棕榈酰乙醇酰胺（PEA）的商业局部制剂在健康人类参与者皮肤中的耐受性概况。
进行了三项人体临床试验和一项体外研究。通过在健康人体皮肤上进行斑贴试验，评估了几种产品的皮肤刺激性、致敏性和光毒性潜力。评估的产品包括两种含有 CBD 和 PEA 的制剂、一种含有大麻籽油和四种浓度的 CBD 制剂。使用传统的鸡胚绒毛尿囊膜模型测试了 CBD、PEA 和大麻籽油制剂的眼部毒性。
在健康参与者的斑贴试验中，没有发现产品的刺激或致敏作用。此外，与阴性对照相比，在 48 小时时发现一种大麻籽油产品具有轻度光毒性。体外实验表明，大麻素产品的作用与历史上非刺激性产品相当。
这些特定的 CBD 和 PEA 含量产品在健康成年人中无刺激性和非致敏性，进一步鼓励类似的研究评估它们在患有皮肤病的人类参与者中的长期安全性和疗效。本研究存在一些局限性：（i）由于本研究仅使用了来自单一制造商的制剂，因此外部有效性可能有限，而市场上未经监管的商业 CBD 产品存在巨大的异质性；（ii）仅在正常、非疾病的人类皮肤上评估了产品，因此不能假设将其外推至患有皮肤病的患者。
