Farage Miranda A, Esquerra Juan, Cheng Richard, Carpenter Stacey, Bunasky Kathryn, Gutshall Denise, Lawrence Ann, Messerschmidt Andre
The Procter and Gamble Company, Cincinnati, OH, USA.
The Procter and Gamble Company, Alcobendas, Spain.
J Cosmet Dermatol. 2018 Oct;17(5):900-910. doi: 10.1111/jocd.12442. Epub 2017 Nov 2.
A growing number of manufacturers are taking advantage of the ability of absorbent consumer products to deliver lotion to the skin. The lotion is included on these products to help protect the skin from adverse skin effects that can occur, including: (1) irritation, (2) over hydration of the stratum corneum, (3) dryness that can occur from extended exposure to highly absorbent consumer products, and (4) changes in pH.
This manuscript presents results of a quantitative lotion transfer study of adult incontinence products. Resulting lotion transfer is compared to the results of several separate experiments in which specific skin benefits have been correlated to lotion concentrations.
The behind-the-knee (BTK) lotion transfer protocol was used to quantitate lotion transfer from adult incontinence (AI) test products constructed using 2 lotion formulations and 2 configurations of lotion application. A modified arm patch protocol, in which skin sites of a measured dimension were pre-treated with specific volumes of lotion, was used to evaluate protective effects of lotion against exposure to irritants, and over hydration from wetted absorbent products.
After a 6-hours continuous exposure in the BTK the 5-stripe lotion configuration products transferred (adjusted mean ± SE) 94 ± 11-104 ± 11 μg/cm lotion. After 24 hours of wear, transfer had increased to 127 ± 22 and 149 ± 24 μg/cm , respectively. The single-block configuration products transferred 289 ± 10-316 ± 10 μg/cm (P = .04). Transfer after 24 hours of wear was 328 ± 23 and 472 ± 21 μg/cm , respectively (P < .0001). Several protocols were used to evaluate the concentration of lotion required to provide four specific skin benefits. In studies evaluating protection against irritants, skin site pre-treated with lotion were patched with 0.5% sodium lauryl sulfate (SLS). Protective effects were assessed by visual assessment of erythema and trans-epidermal water loss (TEWL). In the first experiment, lotion pre-treatment concentrations as low as 165 μg/cm exhibited significantly (P < .05) lower erythema and TEWL compared to the positive irritant control (ie, no lotion pre-treatment and SLS only). In the second experiment, lotion pre-treatment concentrations of 80 μg/cm (P = .018) exhibited significantly (P = .018) lower TEWL. In two studies on protection from over hydration, lotion pre-treatment sites were subsequently patched with wetted absorbent consumer products. The change in TEWL was used as a measure of over hydration. Lotion concentrations significantly reduced the increase in TEWL at 80 μg/cm (P = .007) and 70 μg/cm (P ≤ .05). A BTK study was used to evaluate the ability of lotion to prevent dryness. After 6 hours of wear, test products transferring lotion concentrations of 110 or 133 μg/cm produced significantly lower scores for dryness compared to products transferring 48 or 69 μg/cm . Using collagen sheets to mimic the stratum corneum, an in vitro study was conducted to measure the ability of lotion to prevent passage of high pH buffer solution. Results demonstrated that the lowest concentration of lotion that was tested (110 μg/cm ) interfered with passage of the high pH buffer through the collagen sheet, delaying the rise in pH.
We can conclude that pretreatment with 110 μg/cm lotion acts as a barrier to high pH fluids such as urine. Using the measurement of lotion transfer from the AI products, together with the results of studies conducted to determine the concentration of lotion required to provide specific skin benefits, we conclude that the five-stripe lotion configuration AI test products transferred enough lotion (ie, ≥80 μg/cm ) to provide skin protection with regard to: (1) irritant effects and (2) excess moisture. The single-block AI test products also transferred enough lotion to provide these skin benefits (ie, ≥165 μg/cm ), and the additional benefits of skin protection against: (3) dryness, and (4) changes in pH.
越来越多的制造商利用吸收性消费品向皮肤输送乳液的能力。这些产品中含有乳液,以帮助保护皮肤免受可能出现的不良皮肤影响,包括:(1)刺激;(2)角质层过度水合;(3)长时间接触高吸收性消费品可能导致的干燥;以及(4)pH值变化。
本手稿展示了一项成人失禁产品乳液转移定量研究的结果。将所得的乳液转移结果与几个单独实验的结果进行比较,在这些实验中,特定的皮肤益处与乳液浓度相关。
采用膝后(BTK)乳液转移方案来定量从使用2种乳液配方和2种乳液涂抹配置构建的成人失禁(AI)测试产品中转移的乳液。一种改良的手臂贴片方案被用于评估乳液对接触刺激物的防护效果以及对湿吸收性产品过度水合的防护效果,在该方案中,用特定体积的乳液对测量尺寸的皮肤部位进行预处理。
在BTK中持续暴露6小时后,5条纹乳液配置产品转移(调整后均值±标准误)94±11 - 104±11μg/cm的乳液。穿戴24小时后,转移量分别增加到127±22和149±24μg/cm。单块配置产品转移289±10 - 316±10μg/cm(P = 0.04)。穿戴24小时后的转移量分别为328±23和472±21μg/cm(P < 0.0001)。使用了几种方案来评估提供四种特定皮肤益处所需的乳液浓度。在评估对刺激物防护的研究中,用乳液预处理的皮肤部位用0.5%十二烷基硫酸钠(SLS)贴片。通过对红斑和经表皮水分流失(TEWL)的视觉评估来评估防护效果。在第一个实验中,与阳性刺激对照(即未用乳液预处理且仅用SLS)相比,低至165μg/cm的乳液预处理浓度表现出显著更低的红斑和TEWL(P < 0.05)。在第二个实验中,80μg/cm的乳液预处理浓度表现出显著更低的TEWL(P = 0.018)。在两项关于防止过度水合的研究中,用乳液预处理的部位随后用湿的吸收性消费品贴片。TEWL的变化被用作过度水合的度量。乳液浓度在80μg/cm(P = 0.007)和70μg/cm(P≤0.05)时显著降低了TEWL的增加。一项BTK研究被用于评估乳液预防干燥的能力。穿戴6小时后,转移乳液浓度为110或133μg/cm的测试产品与转移48或69μg/cm的产品相比,干燥得分显著更低。使用胶原片模拟角质层,进行了一项体外研究以测量乳液防止高pH缓冲溶液通过的能力。结果表明,测试的最低乳液浓度(110μg/cm)干扰了高pH缓冲溶液通过胶原片,延迟了pH值的上升。
我们可以得出结论,用110μg/cm的乳液预处理可作为尿液等高pH流体的屏障。通过测量AI产品中乳液的转移量,并结合为确定提供特定皮肤益处所需的乳液浓度而进行的研究结果,我们得出结论,5条纹乳液配置的AI测试产品转移了足够的乳液(即≥80μg/cm)以提供关于以下方面的皮肤保护:(1)刺激作用和(2)过多水分。单块AI测试产品也转移了足够的乳液以提供这些皮肤益处(即≥165μg/cm),以及针对以下方面的额外皮肤保护益处:(3)干燥和(4)pH值变化。