Gfeller Christoph, Hardie George, Shanga Gilbert, Mahalingam Harish
R&D Medical Affairs Skin Health, GSK Consumer Healthcare, Brentford, Middlesex TW8 9GS, United Kingdom (C.G.), R&D Clinical Operations, GSK Consumer Healthcare, Weybridge, Surrey KT13 0DE, United Kingdom (G.H.), R&D Biostatistics, GSK Consumer Healthcare, Warren, New Jersey (G.S.), R&D Medical Affairs Skin Health, GSK Consumer Healthcare, Warren, New Jersey (H.M.).
J Cosmet Sci. 2019 Jan/Feb;70(1):1-15.
This report explores dry-skin models to assess the potential of a new lip balm formulation to hydrate dry skin or lips, and presents sun protection factor (SPF) values for five new lip balm formulations. Evaporimeter [for transepidermal water loss (TEWL)], Skicon, and Corneometer were used to measure hydrating effects of lip balm formulations in a dry-skin leg model, and TEWL, DermaLab Moisture Meter, Corneometer, and visual assessments were used with a dry-lip model. SPF studies were conducted in accordance with either the U.S. Food and Drug Administration monograph final rule or international standard ISO 24444. Data from dry-skin leg model demonstrate that a new lip balm formulation significantly improves skin hydration compared with untreated leg skin and four comparator products. Data obtained from a dry-lip model proved unreliable. Five new lip balm formulations exhibited sunscreen capability; however, they did not meet the intended SPF. There were no product-related adverse events with the formulations. Although the new lip balm formulation improved hydration, data from a novel dry-lip model proved unreliable therefore further testing is required to confirm these benefits. Five new lip balm formulations provided sunscreen capability but did not meet the intended SPF, and will undergo reformulation and retesting.
本报告探讨了干性皮肤模型，以评估一种新型润唇膏配方为干性皮肤或唇部补水的潜力，并给出了五种新型润唇膏配方的防晒系数（SPF）值。使用蒸发仪[用于测量经表皮水分流失（TEWL）]、皮肤水分测试仪和角质层水合度测定仪来测量润唇膏配方在干性腿部皮肤模型中的保湿效果，并在干性唇部模型中使用TEWL、皮肤水分测定仪、角质层水合度测定仪和视觉评估。SPF研究是根据美国食品药品监督管理局的专著最终规则或国际标准ISO 24444进行的。干性腿部皮肤模型的数据表明，与未处理的腿部皮肤和四种对照产品相比，一种新型润唇膏配方能显著改善皮肤水合作用。从干性唇部模型获得的数据被证明不可靠。五种新型润唇膏配方具有防晒能力；然而，它们未达到预期的SPF值。这些配方未出现与产品相关的不良事件。尽管新型润唇膏配方改善了水合作用，但来自新型干性唇部模型的数据被证明不可靠，因此需要进一步测试以证实这些益处。五种新型润唇膏配方具有防晒能力，但未达到预期的SPF值，将进行重新配方和重新测试。
