Fung Wing, Orak Deborah, Re Thomas A, Haughey David B
L'Oreal USA, 30 Terminal Avenue, Clark, NJ 07066, USA.
J Pharm Sci. 2008 Mar;97(3):1325-8. doi: 10.1002/jps.21109.
A single-center, single-sequence, two-period crossover study was performed to compare the systemic exposure to salicylic acid (SA) following facial application of a 30% SA cosmetic skin peel formulation applied for 5 min and an oral dose of 650 mg aspirin in nine healthy male and female subjects. The mean (SD) maximum SA concentration (Cmax) was 0.81 (0.32) microg/mL and 56.4 (14.2) microg/mL. The AUC-based safety margin ratio was 50:1. A depot effect was observed during topical application of the skin peel solution as the absorption of SA continued beyond the 5-min application period. Plasma SA Cmax values were achieved from 1.4 to 3.5 h after topical application and from 0.5 to 1.5 h after oral aspirin. The plasma concentrations in the present study (30%; 5 min) were similar to that of a low concentration (2%) applied in a leave-on product to the same body surface area. In conclusion, our results suggest that the use of this SA facial peel should not pose any significant systemic health risks.
进行了一项单中心、单序列、两阶段交叉研究,以比较9名健康男性和女性受试者面部涂抹30%水杨酸(SA)美容皮肤剥脱制剂5分钟后以及口服650毫克阿司匹林后的水杨酸全身暴露情况。平均(标准差)最大SA浓度(Cmax)分别为0.81(0.32)微克/毫升和56.4(14.2)微克/毫升。基于曲线下面积(AUC)的安全边际比为50:1。在皮肤剥脱溶液局部应用期间观察到了储库效应,因为SA的吸收在5分钟应用期后仍在继续。局部应用后1.4至3.5小时以及口服阿司匹林后0.5至1.5小时达到血浆SA Cmax值。本研究中(30%;5分钟)的血浆浓度与在相同体表面积上涂抹于皮肤上的低浓度(2%)产品相似。总之,我们的结果表明,使用这种SA面部剥脱剂不应带来任何重大的全身健康风险。