Kirsner Robert, Andriessen Anneke
J Drugs Dermatol. 2023 Jan 1;22(1):65-73. doi: 10.36849/JDD.7168.
Diabetes mellitus (DM) is a common disease. Seventy percent of patients present with a cutaneous complication, including xerosis. Ceramides-containing (CER) skincare promotes a healthy skin barrier. This international, multicenter, open-label cohort study evaluated twice-daily application for 1 month of CER-containing cleanser and moisturizing cream to improve DM-related xerosis.
Patients between 18 and 75 years with DM-related xerosis at baseline were eligible. Study visits were on days -30 to 0 (screening), day 0 (baseline), and week 4 (end of study). Evaluations included the Global Aesthetic Improvement Scale (GAIS) and the physician and subject-scored Dry Skin Classification Scale (DSCS). Subject-scored measures of quality of life (QoL) and satisfaction scale with treatment outcomes and product features took place at the end of the study. Tolerance was assessed by monitoring adverse events (AEs).
N = 528 subjects from 19 countries completed treatment, the majority having DM type 2 (82.6%). N = 519 (98.3%) met the primary endpoint criteria (GAIS). The CER-containing skincare regimen resulted in statistically significant improvements from baseline (P<0.001) in all parameters of the physician and subject DSCS scores. Patients reported QoL significantly improved by week 4 (P<0.001). At the end of the study, 99.6% (525) of subjects were satisfied with skincare outcomes and product features (99.4% [524]). No product-related AEs were reported during the study.
CER-containing cleanser and moisturizer were associated with statistically significant improvements in DM-associated xerosis, physician and subject scored severity, patient satisfaction, and improved QoL. The skincare regimen was well tolerated. J Drugs Dermatol. 2023;22(1):65-73. doi:10.36849/JDD.7168.
糖尿病（DM）是一种常见疾病。70%的患者会出现皮肤并发症，包括皮肤干燥。含神经酰胺（CER）的护肤品有助于促进健康的皮肤屏障。这项国际多中心开放标签队列研究评估了每日两次使用含CER的洁面乳和保湿霜1个月对改善糖尿病相关皮肤干燥的效果。
年龄在18至75岁之间、基线时患有糖尿病相关皮肤干燥的患者符合条件。研究访视时间为第-30天至第0天（筛查）、第0天（基线）和第4周（研究结束）。评估包括全球美学改善量表（GAIS）以及医生和受试者评分的干性皮肤分类量表（DSCS）。在研究结束时进行受试者对生活质量（QoL）的评分以及对治疗结果和产品特性的满意度量表调查。通过监测不良事件（AE）评估耐受性。
来自19个国家的528名受试者完成了治疗，其中大多数为2型糖尿病患者（82.6%）。519名（98.3%）受试者达到主要终点标准（GAIS）。含CER的护肤方案在医生和受试者DSCS评分的所有参数方面均较基线有统计学显著改善（P<0.001）。患者报告生活质量在第4周时显著改善（P<0.001）。在研究结束时，99.6%（525名）受试者对护肤效果和产品特性感到满意（99.4%[524名]）。在研究期间未报告与产品相关的不良事件。
含CER的洁面乳和保湿霜与糖尿病相关皮肤干燥、医生和受试者评分的严重程度、患者满意度以及生活质量的改善在统计学上具有显著相关性。该护肤方案耐受性良好。《药物皮肤病学杂志》。2023年；22(1):65 - 73。doi:10.36849/JDD.7168 。
