Farage Miranda A, Santana Marie-Vee, Henley Elizabeth
The Procter & Gamble Company, Winton Hill Business Center, Cincinnati, Ohio 45224, USA.
Cutan Ocul Toxicol. 2005;24(1):45-52. doi: 10.1081/CUS-200046189.
The goal of this preliminary study was to examine data collected in the course of the development and conduct of the behind-the-knee (BTK) test for correlations between the objective scores of erythema and the sensory effects reported by the panelists. In addition, the intensity of physical characteristics of femcare products and prototypes was evaluated using the descriptive analysis panel (DAP) and results were compared to the BTK results to determine if certain physical characteristics of the products correlated to different sensations experienced by the BTK panelists. Test materials were commercially available or developmental catemenial products. In the BTK test, samples were applied daily to the area behind the knee and held in place for 6 hours per day for 5 consecutive days by an elastic knee band of the appropriate size. Irritation was graded 30-60 minutes after removal of each application. The DAP uses individuals trained to recognize and grade certain physical characteristics of products, including degree of plastic feel, scratchiness, glide, and cottony feel. In the BTK studies, the ability to differentiate between the test samples via reported sensory effects correlated with the ability to differentiate via objective scores for irritation in seven of 15 comparisons. A correlation between the magnitude of the irritation score, independent of the specific test sample, and reports of adverse sensory effects was observed in 13 of 15 comparisons. Two comparisons conducted in the BTK were also evaluated using the DAP. For one comparison, there was a clear difference in the product physical characteristics in the DAP that was consistent with mean erythema scores and reported sensory effects in the BTK. For the other comparison, there was no clear difference between the two products by either the DAP or the BTK.
这项初步研究的目的是检查在开发和进行膝后（BTK）测试过程中收集的数据，以确定红斑客观评分与小组成员报告的感官效应之间的相关性。此外，使用描述性分析小组（DAP）评估女性护理产品及其原型的物理特性强度，并将结果与BTK结果进行比较，以确定产品的某些物理特性是否与BTK小组成员体验到的不同感觉相关。测试材料为市售或处于研发阶段的经期护理产品。在BTK测试中，每天将样品涂抹于膝盖后方区域，并用合适尺寸的弹性护膝固定，每天固定6小时，连续进行5天。每次去除样品后30 - 60分钟对刺激进行分级。DAP由经过培训以识别和分级产品某些物理特性的人员组成，这些特性包括塑料感程度、粗糙度、顺滑度和棉质感。在BTK研究中，在15次比较中的7次中，通过报告的感官效应区分测试样品的能力与通过刺激客观评分进行区分的能力相关。在15次比较中的第13次观察到，与特定测试样品无关的刺激评分幅度与不良感官效应报告之间存在相关性。BTK中进行的两次比较也使用DAP进行了评估。对于一次比较，DAP中产品的物理特性存在明显差异，这与BTK中的平均红斑评分和报告的感官效应一致。对于另一次比较，无论是DAP还是BTK，两种产品之间均无明显差异。
