Pinter Andreas, Thouvenin Marie-Dominique, Bacquey Adeline, Rossi Ana Beatris, Nocera Thérèse
Department of Dermatology, Venereology and Allergology, Clinical Research Division, University Clinic Frankfurt am Main, Frankfurt am Main, Germany.
Clinical Skin Research and Development Center, Hôtel Dieu, Pierre Fabre Dermo-Cosmétique, Toulouse, France.
Dermatol Ther (Heidelb). 2019 Jun;9(2):309-319. doi: 10.1007/s13555-019-0295-0. Epub 2019 Apr 9.
Regular emollient application is recommended for managing atopic dermatitis (AD). Although many emollients are available, only AD-tested medical device repairing emollient creams (MDRECs) can be recommended for treating and preventing AD skin lesions. Here, we evaluated the tolerability and benefit of a new MDREC in an open-label study in infants, young children, and adults with mild to moderate AD.
Subjects (or their parents or guardians) were instructed to apply the MDREC to AD lesions or areas of dry skin twice daily for 3 weeks. Investigators assessed tolerability and AD severity at days 1, 8, and 22. Subjects assessed AD severity weekly, recorded any adverse events, and reported their satisfaction with the MDREC at day 22.
Sixty-one subjects (19 infants, 22 children, and 20 adults) were included and 59 completed the study. At inclusion, 49% of the infants and young children and 15% of the adults were experiencing flares of AD. At day 22, the local tolerability of the MDREC was judged by the investigators as excellent in all the children and in 18 of the 20 adult subjects (90%). All adverse events were mild and transient. Investigator- and subject-assessed AD severity progressively decreased at each assessment for each age subgroup.
This study shows that the MDREC was well tolerated when applied to AD skin lesions in infants, young children, and adults and suggests this product can be used daily to control the signs and symptoms of AD.
Laboratoires Dermatologiques Ducray, Pierre Fabre Dermo-Cosmétique.
建议定期使用润肤剂来管理特应性皮炎（AD）。尽管有许多润肤剂可供选择，但只有经过AD测试的医用设备修复润肤霜（MDREC）可用于治疗和预防AD皮肤病变。在此，我们在一项针对轻度至中度AD的婴儿、幼儿和成人的开放标签研究中评估了一种新型MDREC的耐受性和益处。
受试者（或其父母或监护人）被指示每天两次将MDREC涂抹于AD病变或干性皮肤区域，持续3周。研究人员在第1天、第8天和第22天评估耐受性和AD严重程度。受试者每周评估AD严重程度，记录任何不良事件，并在第22天报告他们对MDREC的满意度。
纳入61名受试者（19名婴儿、22名儿童和20名成人），59名完成研究。纳入时，49%的婴儿和幼儿以及15%的成人患有AD发作。在第22天，研究人员判断MDREC在所有儿童和20名成人受试者中的18名（90%）中的局部耐受性极佳。所有不良事件均为轻度且短暂。研究人员和受试者评估的AD严重程度在每个年龄亚组的每次评估中均逐渐降低。
本研究表明，MDREC应用于婴儿、幼儿和成人的AD皮肤病变时耐受性良好，并表明该产品可每日用于控制AD的体征和症状。
皮埃尔·法布尔皮肤化妆品公司迪克雷皮肤病实验室
