Farage Miranda A, Maibach Howard
The Procter & Gamble Company, Cincinnati, Ohio 45224, USA.
Cutan Ocul Toxicol. 2007;26(1):37-43. doi: 10.1080/15569520601183831.
We performed a randomized, paired, double-blind trial involving 14 participants with self-declared normal skin and 15 participants with self-declared sensitive skin to test the cutaneous compatibility of materials of low irritation potential for skin irritation (sanitary pads) elicited by repetitive topical application.
Two test products patches and two control substance patches were applied to the lateral aspect of the upper arm once daily under fully occlusive conditions for 4 days. The positive control patch was moistened with sodium lauryl sulphate (0.1% w/v) and the negative control patch was moistened with 0.9% sodium chloride, as were the two test material patches. The patches were removed, skin irritation (erythema) graded, and new patches applied after each 24-hour period.
There was no significant difference in skin irritation from the test patches between the sensitive and normal skin groups. The two test patches and the negative control patch were significantly less irritating than the positive control in both test groups. Both test patches were comparable to the negative control patch in the normal and sensitive skin groups.
The test materials produced similar degrees of skin irritation among both groups. Overall, there was no statistically significant difference in skin compatibility when the two feminine hygiene product test patches were worn by self-declared normal and sensitive skin groups.
我们进行了一项随机、配对、双盲试验，纳入了14名自称皮肤正常的参与者和15名自称皮肤敏感的参与者，以测试反复局部应用引起皮肤刺激（卫生棉片）的低刺激性材料的皮肤相容性。
在完全封闭的条件下，每天在上臂外侧贴两片测试产品贴片和两片对照物质贴片，持续4天。阳性对照贴片用十二烷基硫酸钠（0.1% w/v）湿润，阴性对照贴片用0.9%氯化钠湿润，两片测试材料贴片也是如此。每24小时更换贴片，去除贴片后对皮肤刺激（红斑）进行分级。
敏感皮肤组和正常皮肤组的测试贴片引起的皮肤刺激无显著差异。在两个测试组中，两片测试贴片和阴性对照贴片的刺激性均明显低于阳性对照。在正常皮肤组和敏感皮肤组中，两片测试贴片与阴性对照贴片相当。
两组中测试材料引起的皮肤刺激程度相似。总体而言，自称皮肤正常和敏感的两组佩戴两种女性卫生用品测试贴片时，皮肤相容性无统计学显著差异。
