医学
酒渣鼻
不利影响
壬二酸
皮肤病科
随机对照试验
痤疮
丘疹脓疱
内科学
胃肠病学
遗传学
生物
作者
Zoe Diana Draelos,Boni E. Elewski,Julie Harper,M. Sand,Gerald Staedtler,Richard Nkulikiyinka,Kaweh Shakery
出处
期刊:PubMed
日期:2015-07-01
卷期号:96 (1): 54-61
被引量:9
摘要
Rosacea is a chronic relapsing skin disorder primarily affecting the face. Although its etiology is not well defined, rosacea is associated with immune dysregulation and inflammation potentiated by external factors. These manifestations lead to skin sensitivity and impaired quality of life. Azelaic acid (AzA) is approved for the treatment of rosacea in a 15% gel formulation. This phase 3 study evaluated the efficacy and safety of AzA in a 15% foam formulation for the treatment of papulopustular rosacea (PPR). Coprimary efficacy end points were treatment success according to investigator global assessment (IGA) and the nominal change in inflammatory lesion count (ILC) from baseline to the end of treatment (EoT). Adverse events (AEs) were evaluated as a measure of safety. The IGA success rate at EoT was significantly greater in the AzA foam group versus vehicle (P<.001; Cochran-Mantel-Haenszel test). Likewise, nominal ILC change at EoT in the AzA foam group showed a significantly greater decrease versus vehicle (P<.001; F test). Drug-related AEs were mainly mild to moderate, cutaneous, and local. Overall, the study results support the efficacy and safety of twice-daily AzA foam 15% in patients with PPR.
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