Department of Dermatology, Chongqing Hospital of Traditional Chinese Medicine, Chongqing, P.R. China.
Medicine (Baltimore). 2022 Aug 5;101(31):e29975. doi: 10.1097/MD.0000000000029975.
The purpose of this study is to screen and evaluate cosmetic products for sensitive skin on the face.
Thirty-five subjects with positive lactic acid sting test (LAST) were recruited from the staff of our hospital from November 2019 to February 2020. First, the human skin enclosed patch test of cosmetic gel (abbreviated as gel) was performed, and then the tested products were continuously applied for 4 weeks to complete the long-term efficacy test. Subjects' sensation of application, pruritus, tingling and burning were assessed on a 0 to 9 scale prior to, 14, and 28 days after topical application. Moreover, the transepidermal water loss rate (TEWL), stratum corneum (SC) hydration, melanin index (MI), erythema index (EI) and dendritic cells and inflammatory cell infiltration were noninvasively detected by the tester. LAST were performed before applying, 14 and 28 days after application, and then the test results were compared.
In this study, a total of 34 people participated in the test. The results of human skin enclosed patch test indicated that only 1 case of grade 1 reaction occurred among the tested subjects. The subjects felt good after applying the products, and the gel showed high degree of skin comfortable, no irritation and good tolerability. Subjective safety evaluation illustrated that the scores of pruritus, tingling and burning of the subjects decreased in D14 and D28 patient revisit, showing statistically significant differences (P < .05). When the gel was applied for 4 weeks, TEWL (8.42 ± 1.12) and EI (201.35 ± 13.51) were lower than the results before application (P < .05), and the SC hydration (65.36 ± 2.56) was higher than that before application (P < .05). There was no correlation between the SC hydration and TEWL (R = 0.092, P = .416). The results of skin CT indicated that the number of facial dendritic cells decreased in 17 subjects (accounting for 50%) in D28 patient revisit, and the degree of inflammatory cell infiltration decreased in 27 subjects (accounting for 80%). Compared with the baseline value, the LAST score and total sensory score decreased after application the product for 4 weeks, and the difference was statistically significant (the mean value of P < .05).
The subjective feeling of application and efficacy of cosmetics in people with sensitive skin could be successfully evaluated by the comprehensive application of human skin enclosed patch test, long-term trial test, subjective safety evaluation and objective efficacy evaluation. And it provides the basis to judge whether the cosmetic is consistent with the efficacy claim of sensitive skin.
本研究旨在对面部敏感性皮肤的化妆品进行筛选和评估。
2019 年 11 月至 2020 年 2 月，从我院工作人员中招募 35 名乳酸刺痛试验（LAST）阳性者。首先进行化妆品凝胶（简称凝胶）的人体皮肤封闭斑贴试验，然后连续应用受试产品 4 周，完成长期疗效试验。在应用前、应用后 14 天和 28 天，受试者应用时的感觉、瘙痒、刺痛和烧灼感采用 0 至 9 分制进行评估。此外，通过测试仪非侵入性地检测经表皮水分流失率（TEWL）、角质层（SC）水合作用、黑色素指数（MI）、红斑指数（EI）和树突状细胞及炎症细胞浸润。在应用前、应用后 14 天和 28 天进行 LAST，并比较测试结果。
本研究共 34 人参加了测试。人体皮肤封闭斑贴试验结果显示，受试人员中仅出现 1 例 1 级反应。受试者应用后感觉良好，凝胶表现出高度的皮肤舒适感、无刺激性和良好的耐受性。主观安全性评价表明，受试者在 D14 和 D28 复诊时的瘙痒、刺痛和烧灼感评分降低，差异具有统计学意义（P <.05）。当凝胶应用 4 周时，TEWL（8.42±1.12）和 EI（201.35±13.51）均低于应用前（P <.05），SC 水合作用（65.36±2.56）高于应用前（P <.05）。SC 水合作用与 TEWL 之间无相关性（R=0.092，P=.416）。皮肤 CT 结果显示，在 D28 复诊时，17 名受试者（占 50%）面部树突状细胞数量减少，27 名受试者（占 80%）炎症细胞浸润程度降低。与基线值相比，应用产品 4 周后 LAST 评分和总感觉评分降低，差异具有统计学意义（P <.05，平均值）。
通过人体皮肤封闭斑贴试验、长期试验、主观安全性评价和客观疗效评价的综合应用，可成功评价敏感性皮肤人群化妆品的应用主观感受和疗效，为判断化妆品是否符合敏感性皮肤的功效宣称提供依据。
