含有TRPV1受体拮抗剂的修护霜对敏感性皮肤的改善作用

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

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TI敏感程度评估(30s,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(TO)、使用后48 h(T2)、使用后28d(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28d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10min,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±3.90g/h·m^(2),较使用前(3.50±1.63,17.82±5.34 g/h.m^(2))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。

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.m^(2) at baseline to 1.46±1.52和14.91±3.90g/h·m^(2) at day 28(P<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.