Abramovits William, Boguniewicz Mark
Department of Dermatology, Baylor University Medical Center, USA.
J Drugs Dermatol. 2006 Mar;5(3):236-44.
MAS063DP cream has received marketing authorization in the US and the European Union for symptom relief of atopic dermatitis (eczema) and contact dermatitis.
A multicenter, randomized, vehicle-controlled, phase IV study was completed in the US.
218 patients aged 18 to 84 years joined this 50-day study. Patients self-administered MAS063DP cream (N=145) or vehicle cream (N=73) 3 times per day to affected areas and those areas prone to be affected. The primary endpoint for efficacy was the change in EASI at Day 22 of treatment, comparing the 2 treatment groups. Secondary outcomes included EASI scores at other time points, IGA, pruritus (100mm VAS), % BSA, and the need for rescue medication.
MAS063DP was statistically (p<.0001) more effective than vehicle in all outcomes at all time points. The incidence of rash was 2.1% in the MAS063DP group versus 5.5% in the vehicle group. Only 2 patients discontinued MAS063DP due to an adverse event.
MAS063DP cream was confirmed to be a safe and effective treatment for mild to moderate atopic dermatitis in adults.
MAS063DP乳膏已在美国和欧盟获得上市许可，用于缓解特应性皮炎（湿疹）和接触性皮炎的症状。
在美国完成了一项多中心、随机、赋形剂对照的IV期研究。
218名年龄在18至84岁之间的患者参与了这项为期50天的研究。患者每天3次对受累区域及易受累区域自行涂抹MAS063DP乳膏（N = 145）或赋形剂乳膏（N = 73）。疗效的主要终点是治疗第22天时两组患者湿疹面积和严重程度指数（EASI）的变化。次要结局包括其他时间点的EASI评分、医师整体评估（IGA）、瘙痒（100mm视觉模拟量表）、体表面积百分比（%BSA）以及使用急救药物的需求。
在所有时间点的所有结局方面M AS063DP在统计学上（p <.0001）均比赋形剂更有效。MAS063DP组皮疹发生率为2.1%，赋形剂组为5.5%。仅2例患者因不良事件停用MAS063DP。
MAS063DP乳膏被证实是治疗成人轻至中度特应性皮炎的一种安全有效的疗法。
