Supplementary Material for: Effects and patient benefits of a 10% urea-based moisturizing lotion on xerosis in aging skin

Introduction Skin senescence leads to decreased lipid and water levels, inducing xerosis with compromised barrier function. Xerosis affects ≈56% of the aging population, usually characterized by skin scaling, itching, and cracking predominating on the lower legs, causing discomfort, limited mobility and increased risk of eczema/infections. With hydrating and barrier strengthening properties, urea-based topical moisturizers are commonly used to manage skin dryness. This observational, open label, single group study, conducted in 59 participants (60 75 years), evaluated the effectiveness, tolerability and patient benefits of a 10% urea based emollient (“U10%”) in the management of moderate to severe senile xerosis of the lower legs. Methods Subjects applied U10% twice daily over 4 weeks. Clinical evaluations by physicians were conducted at Baseline and Day 28 to measure changes in hydration levels, barrier function, and skin texture. Patient-reported outcomes on treatment benefits and quality of life were recorded on Day 7 and Day 28. Results After 4 weeks of treatment, meaningful improvements were observed in the global clinical assessment scores of xerosis, overall dry skin, skin roughness and dryness, total xerosis severity of the lower legs, xerosis severity for erythema, lichenification, desquamation and body surface. Corneometry measurements showed decreased trans-epidermal water loss, in line with improvements in the skin barrier function. Patient-reported outcomes showed marked improvements indicating enhancement in the overall patient perception of benefit and in the patients’ quality of life resulting from treatment. Conclusion This study has provided strong evidence for the potential use of U10% emollient as a highly effective solution tailored to meet unique needs of age-related xerosis and pruritus.

引言 皮肤衰老会导致脂质与水分水平下降，引发干燥症（xerosis）并破坏皮肤屏障功能。干燥症影响约56%的老年人群，通常以小腿为主要受累部位，表现为皮肤脱屑、瘙痒与皲裂，可引发躯体不适、活动受限，并增加湿疹或感染的发病风险。尿素基外用保湿剂兼具保湿与强化皮肤屏障的功效，是临床常用的皮肤干燥改善方案。本项观察性、开放标签、单组研究共纳入59名年龄介于60至75岁的受试者，旨在评估10%尿素润肤剂（"U10%"）用于治疗中重度老年性小腿干燥症的有效性、耐受性及患者获益情况。方法 受试者每日两次涂抹U10%，持续4周。临床医师分别于基线及第28天开展临床评估，以检测皮肤水分水平、屏障功能及皮肤纹理的变化。患者报告的治疗获益与生活质量相关结局指标分别于第7天及第28天进行记录。结果 经过4周治疗后，干燥症的整体临床评估评分、整体皮肤干燥程度、皮肤粗糙与干燥程度、小腿总干燥症严重程度，以及红斑（erythema）、苔藓样变（lichenification）、脱屑（desquamation）相关的干燥症严重程度与体表面积受累情况均出现显著改善。角质电容测量（corneometry）结果显示经表皮水分流失（trans-epidermal water loss）量降低，与皮肤屏障功能的改善情况相符。患者报告的结局指标同样呈现明显改善，表明受试者对治疗获益的整体感知及治疗带来的生活质量均得到提升。结论 本研究为"U10%"润肤剂作为针对老年性干燥症与瘙痒症的高效定制化治疗方案提供了有力证据。