proDERM Institute of Applied Dermatological Research GmbH, Hamburg, Germany.
Kaymogyn GmbH, Wiesbaden, Germany.
Skin Res Technol. 2019 Jul;25(4):578-586. doi: 10.1111/srt.12689. Epub 2019 Feb 16.
BACKGROUND/AIM: The scope of this study was to utilize confocal Raman spectroscopy in the evaluation of the degree of non-penetration into the viable skin layers of a paraffin and petrolatum-based product for use in the intimate areas of the skin. The formulation was purposely designed with properties to prevent undesirable skin penetration.
Product-The test product was a proprietary topical medical device comprising paraffinum liquidum, petrolatum, paraffin, and tocopheryl acetate. Volunteers-A total of 20 healthy volunteers were recruited onto the study-17 females and three males. Product Testing-Raman spectra were obtained at Baseline and 90 minutes after product application. Product Penetration-Skin penetration was calculated from Raman spectra taken at skin depths of -5, 0, 5, 10, 15, and 20 μm.
Raman spectra of the investigated product could be clearly differentiated from the skin spectrum. The minimum measurable concentration of the test product was determined at a detection level of 0.5%. In this study, the test product did not penetrate down to skin depths of 10 to 20 μm.
Within the precision range of the test method, the investigated product did not penetrate into the compact part of the stratum corneum. The study revealed Raman spectroscopy to be suitable to detect not only penetration but also non-penetration of substances into human skin.
背景/目的：本研究旨在利用共焦拉曼光谱评估一种用于皮肤私密部位的基于石蜡和凡士林的产品对非穿透性进入活皮层的程度。该制剂的设计目的是具有防止皮肤不良渗透的特性。
产品-测试产品是一种专有的局部医用器械，由液体石蜡、凡士林、石蜡和醋酸生育酚组成。志愿者-共有 20 名健康志愿者参与了这项研究，其中 17 名女性和 3 名男性。产品测试-在使用产品后 90 分钟内获得拉曼光谱。产品渗透-从皮肤深度为-5、0、5、10、15 和 20μm 的拉曼光谱计算皮肤渗透。
研究产品的拉曼光谱可以与皮肤光谱明显区分开来。在检测水平为 0.5%时，确定了测试产品的最小可测量浓度。在本研究中，测试产品未渗透到 10 至 20μm 的皮肤深度。
在测试方法的精度范围内，研究产品未渗透到角质层的致密部分。该研究表明，拉曼光谱不仅适用于检测物质渗透进入人体皮肤，还适用于检测非渗透。
