Efficacy of a tailored moisturizer for reducing chemotherapy-induced skin dryness in breast cancer patients: A randomized controlled clinical trial

We designed a single-center, randomized controlled trial to test the efficacy of a tailored moisturizer with a high content (1.5%) of pseudo-ceramides that mimics natural ceramides which comprises more than 50% of skin lipids for managing chemotherapy-induced dryness. Breast cancer patients experiencing skin dryness after 1 cycle of chemotherapy were randomized in a 1:1:1 ratio to receive tailored moisturizer; general moisturizer; and usual care from February 2015 to October 2018 at the Samsung Medical Center in South Korea. Patients assigned to tailored or general moisturizer group were asked to apply the moisturizer twice a day from the first day of 2nd cycle of chemotherapy until 1 month after completion of chemotherapy. While usual care group (UCG) was not blinded, the general moisturizer group (GMG) was blinded. Since our intervention was tailored moisturizer for the face, the primary outcome was severe skin-dryness on the face at 1 month after completion of chemotherapy. Severe skin-dryness on face was defined as a response to severe or very severe dryness in Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events. For the secondary outcomes, sebum and water content were measured on the front of the right cheek using a Multi-Probe Adapter System. We also assessed skin dryness and dullness on their face using a 10-point visual analog scale and impairment of dermatological QoL using Dermatology Life Quality Index. The TMG reported lower levels of skin dullness (3.1 vs. 4.6 vs. 4.4) and impairment of dermatological QoL (2.0 vs. 4.8, 3.9) than UCG and GMG respectively. In addition, sebum content in the UCG and GMG were lower at 3 weeks (1.33 vs. -3.05, P < 0.01 vs. -2.11, P = 0.04) and at 1 month after completion of chemotherapy than these of TMG (0.77 vs.-2.64, P = 0.04 vs. -0.96, P = 0.31). Water content showed similar patterns but the differences across the groups were not significant. In conclusion, we demonstrated a tailored moisturizer improved patient reported skin dryness and dullness on face and dermatological QoL compared to usual care in breast cancer patients undergoing chemotherapy. Further studies with larger sample are necessary to confirm the effects on objective skin parameters including epidermal water loss.本研究设计了一项单中心随机对照试验，旨在评估一款含高含量（1.5%）拟神经酰胺（pseudo-ceramides）的定制保湿霜的疗效——该拟神经酰胺可模拟占皮肤脂质50%以上的天然神经酰胺，用于治疗化疗诱导的皮肤干燥。2015年2月至2018年10月，在韩国三星医疗中心，将完成1周期化疗后出现皮肤干燥的乳腺癌患者按1:1:1的比例随机分为三组，分别接受定制保湿霜、普通保湿霜及常规护理。分配至定制或普通保湿霜组的患者需于第2周期化疗首日起至化疗结束后1个月内，每日两次涂抹对应保湿霜。常规护理组（usual care group, UCG）未设盲，而普通保湿霜组（general moisturizer group, GMG）采用盲法设计。由于本研究的干预措施为面部专用定制保湿霜，主要结局指标为化疗结束后1个月时患者的面部重度皮肤干燥情况。面部重度皮肤干燥的定义为：采用患者报告结局版不良事件通用术语标准（Patient-Reported Outcomes version of the Common Terminology Criteria for Adverse Events）评定为重度或极重度干燥的情况。次要结局指标方面，采用多探头适配器系统（Multi-Probe Adapter System）检测右侧面颊前部的皮脂含量与皮肤含水量；同时采用10分量表视觉模拟评分法（visual analog scale, VAS）评估患者面部皮肤干燥与暗沉程度，并采用皮肤病生活质量指数（Dermatology Life Quality Index, DLQI）评定患者的皮肤病相关生活质量受损情况。定制保湿霜组（tailored moisturizer group, TMG）报告的面部暗沉程度（3.1分）及皮肤病相关生活质量受损评分（2.0分）均显著低于UCG（4.6分、4.8分）与GMG（4.4分、3.9分）。此外，化疗结束后3周及1个月时，UCG与GMG的皮脂含量均低于TMG的对应水平：3周时UCG皮脂含量为1.33，与TMG的0.77相比P<0.01，GMG为-3.05，与TMG的-2.11相比P=0.04；1个月时UCG皮脂含量为0.77，与TMG的-2.64相比P=0.04，GMG为-0.96，与TMG的对应值相比差异无统计学意义（P=0.31）。皮肤含水量的变化趋势与皮脂含量相似，但组间差异无统计学意义。综上，本研究证实，相较于常规护理，定制保湿霜可改善化疗期乳腺癌患者的自我报告面部皮肤干燥、暗沉情况及皮肤病相关生活质量。未来需开展更大样本量的研究，以验证其对包括表皮水分丢失在内的客观皮肤参数的改善效果。