Yeerong Kankanit, Ampasavate Chadarat, Rayanakorn Ajaree, Chuamanochan Mati, Tovanabutra Napatra, Na Takuathung Mingkwan, Koonrungsesomboon Nut
Clinical Research Center for Food and Herbal Product Trials and Development (CR-FAH), Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.
Department of Pharmacology, Faculty of Medicine, Chiang Mai University, Chiang Mai, Thailand.
BMJ Open. 2025 Jul 28;15(7):e103571. doi: 10.1136/bmjopen-2025-103571.
Evaluating skin reactions is crucial in topical product development. Turmeric/epigallocatechin-3-gallate (EGCG) emulgel demonstrates therapeutic potential for cutaneous diseases, warranting further investigation in human studies. The Human Repeat Insult Patch Test (HRIPT) of skin irritation and sensitisation potential caused by the turmeric/EGCG emulgel is designed to evaluate the safety of the investigational product in healthy volunteers prior to conducting the efficacy study in patients with dermatological diseases.
60 healthy Thai volunteers will be enrolled in this single-centre, double-blind HRIPT pilot clinical trial to evaluate skin irritation and sensitisation potential caused by turmeric/EGCG emulgel. Primary endpoints include the number and proportion of participants exhibiting skin irritation and sensitisation, while secondary endpoints focus on the frequency and severity of adverse events. The study will comprise a screening period, a 3-week induction phase, a 2-week rest phase and a 1-week challenge phase. Fully occlusive adhesive patches containing study products will be applied to participants' backs 10 times. Skin irritation will be assessed using the Draize dermal irritation scoring system, and skin sensitisation will be evaluated using the International Contact Dermatitis Research Group scoring system.
The Research Ethics Committee of the Faculty of Medicine, Chiang Mai University, approved this study protocol and related documents on 6 March 2025 (Ref. No. 108/2025).
TCTR20250317007.
在局部用产品研发中，评估皮肤反应至关重要。姜黄/表没食子儿茶素-3-没食子酸酯（EGCG）乳胶凝胶显示出对皮肤疾病的治疗潜力，值得在人体研究中进一步探究。姜黄/EGCG乳胶凝胶引起的皮肤刺激和致敏潜力的人体重复刺激斑贴试验（HRIPT）旨在在对皮肤病患者进行疗效研究之前，评估受试产品在健康志愿者中的安全性。
60名健康的泰国志愿者将参与这项单中心、双盲HRIPT试点临床试验，以评估姜黄/EGCG乳胶凝胶引起的皮肤刺激和致敏潜力。主要终点包括出现皮肤刺激和致敏的参与者数量及比例，次要终点则关注不良事件的频率和严重程度。该研究将包括一个筛选期、一个为期3周的诱导期、一个为期2周的休息期和一个为期1周的激发期。含有研究产品的完全封闭性粘贴斑贴将贴于参与者背部10次。将使用德雷兹皮肤刺激评分系统评估皮肤刺激情况，并使用国际接触性皮炎研究组评分系统评估皮肤致敏情况。
清迈大学医学院研究伦理委员会于2025年3月6日批准了本研究方案及相关文件（参考编号108/2025）。
TCTR20250317007。
