BMJ open · 2025
Skin evaluation of turmeric/epigallocatechin-3-gallate emulgel for skin irritation and sensitisation effects in healthy Thai participants (TULIP): a protocol for a randomised, double-blind, placebo-controlled trial.
СтатьяПротокол клинического исследованияНазвание и аннотация: Перевод в очереди
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Yeerong Kankanit, Ampasavate Chadarat, Rayanakorn Ajaree, Chuamanochan Mati, Tovanabutra Napatra, Na Takuathung Mingkwan, Koonrungsesomboon Nut
Аннотация
BACKGROUND: 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.
METHODS AND ANALYSIS: 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.
ETHICS AND DISSEMINATION: 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).
TRIAL REGISTRATION NUMBER: TCTR20250317007.
METHODS AND ANALYSIS: 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.
ETHICS AND DISSEMINATION: 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).
TRIAL REGISTRATION NUMBER: TCTR20250317007.