Institute of Allergology, Charité - Universitätsmedizin Berlin, Berlin, Germany.
Allergology and Immunology, Fraunhofer Institute for Translational Medicine and Pharmacology ITMP, Berlin, Germany.
Skin Pharmacol Physiol. 2024;37(1-3):40-48. doi: 10.1159/000539411. Epub 2024 May 22.
Non-invasive measurement of the stratum corneum hydration (SCH) with capacitance-based instrumentation is established in dermatological and cosmetic studies. We wanted to test the reliability of non-invasive self-measurements for SCH performed under real-life conditions by volunteers with a Bluetooth-based (wireless) probe Corneometer® (CM 825i) transmitting the data via a smartphone application to a central server. Probes and smartphones communicated using Bluetooth Low Energy. Data from the smartphone were securely transferred to a remote server in a different country with TLS encryption using HTTPS protocols. CM 825i values were correlated with the established CM 825 under laboratory conditions. The primary endpoint was the correlation of the two probes. Secondary endpoints were the coefficient of variation (CV) and delta values (before and after treatment).
Eighteen healthy volunteers (f: 8; m: 10) participated in the prospective observational study. The real-world home use of the wireless CM 825i was performed before and after treatments with base cream DAC for 7 days.
Both instruments showed a significant and relevant correlation (p < 0.0001; Spearman coefficient of r = 0.8647). CM 825i and CM 825 differentiate significantly between normal and high SCH. Both devices showed comparable robustness in repeated measurements with a CV between 5.6% and 9.2%.
We could show a significant correlation between both devices and a comparable differentiation between low and high SCH and comparable CVs. The real-life use demonstrated adequate acquiring and transmitting of in vivo data to a smartphone and subsequently transmitting to the secure server with low numbers of missed transmissions (<0.2%) and missed measurements (<5%).
基于电容的仪器对表皮水分(SCH)的非侵入性测量已在皮肤科和化妆品研究中得到确立。我们希望通过志愿者使用基于蓝牙(无线)探头 Corneometer®(CM 825i)进行现场条件下的 SCH 非侵入性自我测量,来测试其可靠性。该探头通过智能手机应用程序将数据传输到中央服务器,从而传输数据。探头和智能手机使用蓝牙低能通信。使用 HTTPS 协议通过 TLS 加密将智能手机的数据安全传输到位于不同国家的远程服务器。CM 825i 值与在实验室条件下的既定 CM 825 值相关。主要终点是两个探头的相关性。次要终点是变异系数(CV)和差值(治疗前后)。
18 名健康志愿者(女性 8 名;男性 10 名)参与了这项前瞻性观察研究。在使用基础霜 DAC 治疗 7 天后,志愿者在家中实际使用无线 CM 825i 进行了治疗前和治疗后的自我测量。
两种仪器均显示出显著且相关的相关性(p < 0.0001;Spearman 相关系数 r = 0.8647)。CM 825i 和 CM 825 可显著区分正常和高 SCH。两种设备在重复测量中均具有相似的稳健性,CV 在 5.6%至 9.2%之间。
我们可以证明两种设备之间存在显著相关性,并且能够在低 SCH 和高 SCH 之间进行相似的区分,并且具有相似的 CV。实际使用表明,能够从体内获取和传输足够的数据到智能手机,随后以低传输失败率(<0.2%)和测量失败率(<5%)传输到安全服务器。