中国麻风皮肤病杂志 ›› 2024, Vol. 40 ›› Issue (2): 106-112.doi: 10.12144/zgmfskin202402106

• 论著 • 上一篇    下一篇

含有TRPV1受体拮抗剂的修护霜对敏感性皮肤的改善作用

张文萱1,夏金玉1,姚新宇1,白倩倩1,吴蕴颖1,宫姝1,尚盼盼1,那君1,吴艳1,李航1,田甜2,郝健晨2,甄甄3,尚美霞4,张瑛5,仲少敏1   

  1. 1北京大学第一医院皮肤科，国家皮肤与免疫疾病临床医学研究中心，北京市皮肤病分子诊断重点实验室，国家药品监督管理局化妆品质量控制与评价重点实验室，北京，100034;
    2北京大学第一医院眼科，北京，100034;
    3北京大学第一医院耳鼻咽喉头颈外科，北京，100034;
    4北京大学第一医院医学统计室，北京，100034;
    5皮尔法伯(上海)化妆品贸易有限公司皮肤学研究室，上海，200070
  • 出版日期:2024-02-15 发布日期:2024-01-30

Tolerance and soothing efficacy of a cream containing TRPV1 receptor antagonist on the sensitive skin

ZHANG Wenxuan1, XIA Jinyu1, YAO Xinyu1, BAI Qianqian1, WU Yunying1, GONG Shu1, SHANG Panpan1, NA Jun1, WU Yan1, LI Hang1, TIAN Tian2, HAO Jianchen2, ZHEN Zhen3, SHANG Meixia4, ZHANG Ying5, ZHONG Shaomin1   

  1. 1 Department of Dermatology, Peking University First Hospital, National Clinical Research Center for Skin and Immune Diseases, Beijing Key Laboratory of Molecular Diagnosis on Dermatoses, NMPA Key Laboratory for Quality Control and Evaluation of Cosmetics, Beijing 100034, China;
    2 Department of Ophthalmology, Peking University First Hospital, Beijing 100034, China;
    3 Department of Otolaryngology, Head and Neck Surgery, Peking University First Hospital, Beijing 100034, China;
    4 Department of Biostatistics, Peking University First Hospital，Beijing 100034, China;
    5 Dermatology Laboratory of Pierre Fabre（Shanghai）Dermo-Cosmétique Trading Co., Ltd, Shanghai 200070, China
  • Online:2024-02-15 Published:2024-01-30

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摘要： 目的：评价含有TRPV1受体拮抗剂的修护霜对敏感性皮肤的改善作用及安全性。方法：采用半脸对照及使用前后自身对照研究，受试者在第一次随访根据随机号将修护霜涂抹于单侧面部，使用本品后进行即刻时间点T1敏感程度评估（30 s、1 min、10 min）。随后研究期间全面部涂抹修护霜每天2次，共28天。分别在使用前（T0）、使用后48 h（T2）、使用后28 d（T3）进行面部乳酸刺痛实验、生理指标检测及皮肤敏感状态主观评分。由皮肤科医生，眼科医生及耳鼻喉科医生分别在使用前和使用后10 min、48 h及28 d对皮肤和眼部鼻部黏膜耐受性进行评估。结果：共收集39例受试者。受试者单侧面部涂抹修护霜10 min，与未用修护霜侧相比，敏感评估量表各维度评分下降，具有统计学意义（P<0.001），受试者的皮肤刺激症状迅速改善。在使用修护霜30 s、1 min、10 min、48 h以及28 d后，各项敏感评估评分均较使用前下降，具有统计学意义（P＜0.001）。使用修护霜后28天，乳酸刺痛实验评分和经表皮失水率，分别为1.46±1.52和14.91±3.90 g/h·m2，较使用前（3.50±1.63，17.82±5.34 g/h·m2）降低。受试区角质层含水量（62.90±10.83）较使用前（53.91±16.07）水平增加（P＜0.001），差异均具有统计学意义(P<0.01)；红斑指数、pH值变化无统计学差异。研究期间未观察到与修护霜使用相关的皮肤、眼部和鼻部的任何刺激性反应及其他不良反应。结论：含有TRPV1受体拮抗剂的修护霜可快速缓解敏感性皮肤的多种不适症状并可以修复皮肤屏障，耐受性良好。

关键词: 敏感性皮肤, 瞬时受体电位香草酸亚型1, TRPV1受体拮抗剂

Abstract: Objective: To evaluate the immediate and long-term efficacy and safety of a cream containing a TRPV1 receptor antagonist on sensitive skin under normal conditions of use. Methods: This is a prospective split face and self-controlled trial. The subjects applied the product on the randomly assigned side of the face on the first visit (T0) and immediately evaluated the sensitivity by Scale-10 scales at the short-term time points (T1: 30s, 1min, 10min). Then all subjects applied the cream on the full face twice per day for 28 days and were followed up at 48h and day 28. Lactic acid stinging test (LAST), skin physiological parameters, SS-10 scales were assessed at T0, 48h (T2), and D28 (T3). The tolerance was evaluated by dermatologists, ophthalmologists and otorhinolaryngologists respectively. Results: A total of 39 cases were recruited. The SS-10 scores showed that immediately (10min) after the product application，the scores of each dimension of the sensitivity assessment scale decreased significantly compared with the control side (P<0.001), and the skin irritation symptoms improved rapidly. After using the product for 30s, 1min, 10min, 48h and 28 days, the sensitivity assessment scores were significantly lower than the baseline (P<0.001). The LAST score and TEWL decreased from 3.50±1.63, 17.82±5.34 g/h/m2 at baseline to 1.46±1.52 and 14.91±3.90 g/h/m2 at day 28 (Ps＜0.001), the skin hydration increased from 53.9±16.07 to 62.90±10.30 (P＜0.001). There were no significant differences in the change of pH value and erythema index before application and after 28 days (P<0.001). No skin, eye or nasal irritation and other adverse reactions associated with product use were observed during the trial. Conclusion: The cream containing TRPV1 receptor antagonists can immediately relieve symptoms of sensitive skin and repair the skin barrier, with no adverse reaction.

Key words: sensitive skin, transient receptor potential vanilloid type1, TRPV1, TRPV1 receptor antagonist