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Topical application of Jaungo in atopic dermatitis patients: study protocol for a randomized, controlled trial

机译：Jaungo在特应性皮炎患者中的局部应用：一项随机对照试验的研究方案

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Background Atopic dermatitis (AD) is a common pruritic inflammatory skin disease with increasing prevalence. It can manifest with many different clinical phenotypes; however, in its chronic stage, hyperpigmentation, excoriation, lichenification, and dryness are the main symptoms. Jaungo comprises two herbs, Lithospermi radix and Angelica gigantis radix, and three carrier oils, and is an approved herbal ointment for xerosis cutis in Korea. In past studies, we demonstrated that Jaungo had anti-inflammatory and antiallergic activity in in vitro and in vivo AD models; however, there are few relevant randomized controlled clinical trials on Jaungo in AD. Methods/design A randomized, double-blind, placebo-controlled, single-center, phase IIa clinical trial was designed to investigate the safety, preliminary efficacy, and dose response of Jaungo in AD. The study protocol was approved by the Institutional Review Boards of the Kyung Hee University Korean Medicine Hospital (No. KOMCIRB-160617-HR-027) and the Korea Food and Drug Administration (No. 30907). The study aims to enroll 34?AD patients to be randomly distributed among three parallel groups: treatment 1, treatment 2, and the placebo group. Treatment group 1 applies Jaungo twice a day, while treatment group 2 applies Jaungo and the placebo ointment once a day, separately, and the placebo group applies the placebo ointment twice a day, for a total of 3?weeks each. Participants will be evaluated for eczema before and after the application of the ointments based on several parameters including the Eczema Area and Severity Index, the SCORing of Atopic Dermatitis Index, the Dermatology Life Quality Index, transepidermal water loss, total IgE level, eosinophil count, and IL-17, IL-22, and IFN-γ levels. Discussion The trial is currently ongoing and the enrollment of subjects has been initiated. There is an urgent need to develop a drug for the treatment of dry, hyperpigmented, scaly, and thickened skin in chronic-stage AD. This study will determine the efficacy and safety of Jaungo in AD, providing evidence for specific AD symptoms treated by Jaungo . Trial registration Clinical Trials.gov, identifier: NCT02900131 . Registered on 2 September 2016. Korea Clinical Research Information Service, identifier: KCT0002060 . Registered on 22 July 2016.
机译：背景技术特应性皮炎（AD）是一种常见的瘙痒性炎症性皮肤病，患病率不断上升。它可以表现出许多不同的临床表型。然而，在其慢性阶段，色素沉着过度，剥落，苔藓化和干燥是主要症状。 Jaungo包含两种草药，Lithospermi radix和Angelica gigantis radix，以及三种载体油，并且是韩国认可的用于皮肤干燥症的草药软膏。在过去的研究中，我们证明了Jaungo在体外和体内AD模型中均具有抗炎和抗过敏活性。然而，关于AD的Jaungo的相关随机对照临床试验很少。方法/设计设计一项随机，双盲，安慰剂对照，单中心，IIa期临床试验，以研究Jaungo在AD中的安全性，初步疗效和剂量反应。该研究方案已由庆熙大学韩国医学医院（第KOMCIRB-160617-HR-027号）和韩国食品药品监督管理局（第30907号）的机构审查委员会批准。该研究旨在招募34位AD患者，将其随机分为三个平行组：治疗1，治疗2和安慰剂组。治疗组1每天两次应用Jaungo，而治疗组2每天分别应用Jaungo和安慰剂软膏，安慰剂组每天两次应用安慰剂软膏，每次共3星期。在使用软膏前后，将根据以下几个参数对参与者进行湿疹评估：湿疹面积和严重程度指数，特应性皮炎的SCORing指数，皮肤病生活质量指数，表皮水分流失，总IgE水平，嗜酸性粒细胞计数， IL-17，IL-22和IFN-γ水平。讨论该试验目前正在进行中，并且已经开始招募受试者。迫切需要开发一种用于治疗慢性AD的干燥，色素沉着，鳞屑和增厚的皮肤的药物。这项研究将确定Jaungo在AD中的疗效和安全性，为Jaungo治疗的特定AD症状提供证据。试验注册Clinical Trials.gov，标识符：NCT02900131。 2016年9月2日注册。韩国临床研究信息服务，标识符：KCT0002060。 2016年7月22日注册。

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