论文部分内容阅读
美国FDA近日批准Stiefel公司Fabior 0.1%泡沫用于治疗年龄≥12岁患者的寻常型痤疮。本品为含维甲酸配方的局部外用泡沫。此项批准主要基于2项在美国和加拿大开展的多中心、随机、双盲、安慰剂对照、关键性III期研究的结果。根据产品标签上的说明,Fabior对寻常型痤疮的作用机制尚不明确,但可能与其具有抗过度增生、促进分化恢复正常以及抗炎作用有关(Stiefel公司新闻)。
US FDA recently approved Stiefel’s Fabior 0.1% foam for the treatment of acne vulgaris in patients over 12 years of age. This product is topical foam with retinoic acid formula. This approval is based largely on the results of two multicenter, randomized, double-blind, placebo-controlled, pivotal phase III studies in the United States and Canada. According to the label on the product label, Fabior’s mechanism of action on acne vulgaris is unclear, but may be related to its anti-hyperproliferation, promotion of normalized differentiation and anti-inflammatory effects (Stiefel News).