The vulvar epithelium differs from the skin: implications for cutaneous testing to address topical vulvar exposures
The vulvar epithelium differs from the skin: implications for cutaneous testing to address topical vulvar exposures
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DOI：
10.1111/j.0105-1873.2004.00444.x
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发表时间：
2004-10-01
影响因子：
5.5
通讯作者：
Maibach, HI
中科院分区：
文献类型：
--
作者：
Farage, M;Maibach, HI
由于结构、闭塞、水合和摩擦敏感性的差异，外阴组织比暴露的皮肤更具渗透性。对接触外阴的产品进行安全评估时应考虑到这种潜在的高渗透性。标准临床斑贴试验可能不足以模拟外阴暴露。由于外阴测试通常不可行，因此我们正在研究新的和改进的皮肤测试方法，以提高安全评估的保守程度。为此，我们 1) 开发了一种通过重复应用于腘窝（膝后测试）来评估化学和摩擦效应的方法； 2）修改了诱发过敏性接触性皮炎的定量风险评估； 3) 提出了一种改进的人体重复损伤斑贴试验，用于评估用于外阴接触的材料。通过使用湿样本或受损皮肤部位对传统的 4 天刺激斑贴试验进行修改，未能提高测试灵敏度。未来的研究将评估对化学和感官刺激高度敏感的受试者的测试，以提高测试对化学刺激物的敏感性。当皮肤测试方法应用于接触外阴的药剂时，这些方法可用于增加安全范围。
Vulvar tissue is more permeable than exposed skin due to differences in structure, occlusion, hydration and susceptibility to friction. The safety assessment of products that contact the vulva should account for this potentially heightened permeability. Standard clinical patch tests may not sufficiently mimic vulvar exposures. Because testing on the vulva is not routinely feasible, we are investigating new and modified cutaneous test methods to increase the degree of conservatism of the safety assessment. To this end, we have 1) developed a method to assess chemical and frictional effects by means of repeated application to the popliteal fossa (the behind-the-knee test); 2) modified the quantitative risk assessment for the induction of allergic contact dermatitis; and 3) proposed a modified human repeat insult patch test for assessing materials intended for vulvar contact. Modification of the traditional 4-day, irritation patch test by using wet samples or compromized skin sites failed to enhance test sensitivity. Future studies will evaluate testing in subjects with heightened susceptibility to chemical and sensory irritation, in order to increase test sensitivity to chemical irritants. These approaches can be employed to augment the margin of safety when cutaneous test methods are applied to agents that contact the vulva.