Tyring Stephen K, Kircik Leon H, Pariser David M, Guenin Eric, Bhatt Varsha, Pillai Radhakrishnan
J Drugs Dermatol. 2018 Oct 1;17(10):1084-1091.
Topical tretinoin has been extensively studied in clinical trials, and its essential role in the treatment of acne vulgaris (acne) established through evidence-based guidelines.
To evaluate efficacy, safety, and tolerability of a novel tretinoin 0.05% lotion in moderate-to-severe acne in patients aged 9 years and older.
A total of 1640 patients, 9-58 years of age were randomized to receive tretinoin 0.05% lotion or vehicle in two double-blind, placebo-controlled 12-week, 2-arm, parallel group studies evaluating safety and efficacy (inflammatory and noninflammatory lesion counts and acne severity using Evaluator Global Severity Scores [EGSS]). In addition, patients completed a patient satisfaction survey (PSS), Acne-specific quality of life (QoL) questionnaire and assessed their facial skin for shininess/oiliness improvement. The data from these two independent studies were pooled and analyzed.
Tretinoin 0.05% lotion demonstrated statistically significant superiority to vehicle in reducing inflammatory and noninflammatory lesion counts (both P less than .001) at week 12 and improving acne severity (P less than .001). At week 12, mean percent change in inflammatory and noninflammatory lesions were 52% and 46%, respectively. Treatment success (a 2-grade improvement in EGSS and 'clear' or 'almost clear' was reported in 18% of patients. Tretinoin 0.05% lotion also showed significantly greater benefits relative to vehicle control in terms of patient satisfaction (P less than .001) and acne-specific QoL domains. Tretinoin 0.05% lotion was very well tolerated with no substantive differences in cutaneous tolerability among treatment groups. No patients discontinued treatment because of adverse events.
Data from controlled studies may differ from clinical practice.
Tretinoin 0.05% lotion provides statistically significant greater efficacy than vehicle with a highly favorable safety and tolerability profile in moderate-to-severe acne patients. J Drugs Dermatol. 2018;17(10):1084-1091.
外用维甲酸已在临床试验中得到广泛研究，其在寻常痤疮治疗中的重要作用已通过循证指南得以确立。
评估一种新型0.05%维甲酸洗剂对9岁及以上中重度痤疮患者的疗效、安全性和耐受性。
在两项双盲、安慰剂对照、为期12周、双臂平行组研究中，共1640例年龄在9至58岁的患者被随机分配接受0.05%维甲酸洗剂或赋形剂，以评估安全性和疗效（采用评估者整体严重程度评分[EGSS]对炎性和非炎性皮损计数及痤疮严重程度进行评估）。此外，患者完成了患者满意度调查（PSS）、痤疮特异性生活质量（QoL）问卷，并对面部皮肤的光泽/油腻改善情况进行了评估。对这两项独立研究的数据进行汇总和分析。
在第12周时，0.05%维甲酸洗剂在减少炎性和非炎性皮损计数方面（P均小于0.001）以及改善痤疮严重程度方面（P小于0.001），与赋形剂相比均显示出统计学上的显著优势。在第12周时，炎性和非炎性皮损的平均变化百分比分别为52%和46%。18%的患者报告治疗成功（EGSS改善2级且“清除”或“几乎清除”）。在患者满意度（P小于0.001）和痤疮特异性QoL领域方面，0.05%维甲酸洗剂相对于赋形剂对照也显示出显著更大的益处。0.05%维甲酸洗剂耐受性良好，各治疗组在皮肤耐受性方面无实质性差异。没有患者因不良事件而停药。
对照研究的数据可能与临床实践有所不同。
0.05%维甲酸洗剂在中重度痤疮患者中，与赋形剂相比，在统计学上具有显著更高的疗效，且安全性和耐受性良好。《药物皮肤病学杂志》。2018年；17(10):1084 - 1091。
