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