对健康志愿者Cussons Baby Sensicare皮肤系列产品的皮肤刺激和致敏电位的评价

Yullya S. Mulyanti, Yuliarni, Busarin Kasemchainan, P. Mitra, P. Evans, Haryono Hartono
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摘要

产品简介:Cussons Baby Sensicare系列是新开发的一套产品,专为新生儿、敏感和易患湿疹的皮肤而设计。因此,这些产品在使用前需要进行测试,以评估其对皮肤的刺激和致敏潜力。产品通过两个单独的测试进行评估。第一次试验采用评估盲、随机人体皮肤刺激贴片试验(48小时/96小时暴露)进行单中心、受试者内比较,并对敏感、特应性皮肤的健康成人进行试验。第二次试验在单中心对照(无菌水)中进行,受试者使用人体重复损伤贴片试验(HRIPTs),受试者为健康的印度尼西亚和亚洲成年女性,皮肤敏感。根据国际接触性皮炎研究小组(ICDRG)在去除贴片后30分钟、24小时、48小时和72小时的评分,确定每种产品的致敏潜力。皮肤刺激试验结果显示,各产品在各自时间点的刺激评分均显著低于阳性对照月桂醇硫酸钠(SLS) (p < 0.05),而与阴性对照(无菌水)无显著差异。HRIPTs结果显示,Cussons Baby Sensicare Range无致敏性。因此,可以得出结论,Cussons婴儿敏感系列产品在皮肤上具有良好的耐受性,并且具有低皮肤刺激和致敏潜力。因此,它们可以被认为是低过敏性的敏感皮肤和适合湿疹易发的皮肤。
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Evaluation of the Skin Irritation and Sensitization Potential of the Cussons Baby Sensicare Skin Range of Products in Healthy Volunteers
Introduction: The Cussons Baby Sensicare Range is a newly developed set of products specially formulated for newborn, sensitive and eczema prone skin. As such, these products need to be tested to evaluate their skin irritation and sensitization potential before use. The products were evaluated with two separate tests. The first test was conducted in a single-center, within-subject comparison using assessor-blind, randomised human skin irritation patch test (48 hour/96 hour exposure) and conducted on healthy adults with sensitive, atopic skin. The second test was conducted in a single-center, controlled (sterile water), within subject using human repeat-insult patch tests (HRIPTs) and conducted on healthy female Indonesian and Asian adult female subjects, with sensitive skin. The sensitization potential of each product was determined from International Contact Dermatitis Research Group (ICDRG) scores at 30 minutes, 24 hours, 48 hours and 72 hours after patch removal. Skin irritation tests show that all products were significantly lower than the positive control sodium lauryl sulphate (SLS) (p < 0.05) but not significantly different to the negative control (sterile water) in terms of irritation scores at the respective time points. HRIPTs results show that Cussons Baby Sensicare Range was non-sensitizing. As such, it can be concluded that the Cussons Baby Sensicare Range tested is well tolerated on skin and has low skin irritation and sensitization potential. Thus, they can be considered hypoallergenic on sensitive skin and suitable for eczema prone skin.
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