GSK Consumer Healthcare, St George's Avenue, Weybridge, Surrey, UK.
J Cosmet Dermatol. 2019 Feb;18(1):377-382. doi: 10.1111/jocd.12535. Epub 2018 Apr 15.
New cosmetic products should undergo clinical evaluation for skin sensitization potential.
To assess the irritation and sensitization potential of a moisturizer containing lamellar structured lipids after repeated patch application in humans, using human repeated insult patch test methodology.
This 6-week, single-center, open-label study compared a lamellar moisturizer with negative saline control in human subjects aged 18-70 years and skin phototype (Fitzpatrick) classification I-IV. During an initial induction phase, semi-occlusive multi-test patches were applied to the skin of participants' backs three times per week for 3 consecutive weeks; clinical assessments were performed per International Contact Dermatitis Research Group criteria. Participants subsequently underwent a challenge phase, where a new patch was applied to a contact-naïve area of the skin to assess sensitization to the moisturizer.
The study commenced with 233 voluntary participants, 214 of whom completed the study and underwent the final dermatological assessment. Most participants (232/233; 99.6%) demonstrated negative patch test results. One participant had a positive reaction at the lamellar moisturizer application site, with visible erythema and edema (classified as an adverse event [AE]); however, this reaction was observed 24 hours after a reaction to another product in the patch test panel (a prototype cleanser). Importantly, no skin reactions were detected during the challenge phase. Two participants had AEs of mild contact dermatitis in the area of patch adhesive application during the induction phase. No serious AEs occurred during the study.
These findings suggest that the lamellar moisturizer has low irritant and allergenic potential.
新的化妆品应进行皮肤致敏性的临床评估。
采用人体重复斑贴试验方法，评估含层状结构脂质的保湿剂重复贴敷后的皮肤刺激性和致敏性。
这项为期 6 周、单中心、开放性研究在年龄 18-70 岁且皮肤光型（Fitzpatrick）分类为 I-IV 的健康志愿者中，比较了层状保湿剂与阴性生理盐水对照。在初始诱导阶段，每周 3 次将半封闭多测试贴片应用于参与者背部皮肤，持续 3 周；根据国际接触性皮炎研究组标准进行临床评估。随后，参与者进入挑战阶段，将新贴片应用于皮肤的接触性未致敏区域，以评估对保湿剂的致敏情况。
该研究共纳入 233 名志愿者，其中 214 名完成了研究并接受了最终的皮肤科评估。大多数参与者（232/233；99.6%）的斑贴试验结果为阴性。一名参与者在层状保湿剂应用部位出现阳性反应，表现为红斑和水肿（归类为不良事件 [AE]）；然而，这一反应是在斑贴试验组合中另一种产品（原型清洁剂）贴敷后 24 小时观察到的。重要的是，在挑战阶段未检测到皮肤反应。在诱导阶段，有两名参与者在贴片贴附区域出现轻度接触性皮炎的 AE。研究期间未发生严重的 AE。
这些发现表明，层状保湿剂具有低刺激性和变应原性潜力。
