医学
耐受性
痤疮
过氧化苯甲酰
临床终点
胃肠病学
内科学
不利影响
病变
随机对照试验
维甲酸
双盲
皮肤病科
外科
安慰剂
病理
维甲酸
替代医学
聚合物
化学
有机化学
基因
生物化学
聚合
作者
Guy Webster,Jeffrey Sugarman,Ofra Levy-Hacham,Ofer Toledano
出处
期刊:Skinmed
[Wiley]
日期:2020-12-01
卷期号:18 (6): 343-351
被引量:7
摘要
This phase 2, 12-week, multicenter, randomized, double-blind, active- and vehicle-controlled (VC), parallel-group trial assessed the efficacy and safety of silica encapsulated benzoyl peroxide BP (E-BP), two concentrations of silica encapsulated tretinoin (E-ATRA) and their combinations (TWIN high and low) vs VC in 726 males and females ≥9 years of age with moderate-to-severe inflammatory facial acne. The co-primary efficacy endpoints were Investigators Global Assessment (IGA) success rate (clear or almost clear) and changes from baseline in inflammatory and non-inflammatory lesion counts. TWIN high and low were each significantly superior vs VC for IGA success at 12 weeks (39.7% and 27.4%, respectively, vs 12.3%, P < 0.001 and P < 0.01). TWIN high and low resulted in mean reductions in inflammatory lesions of -16.9 (64%) and -17.0 (60.8%) vs -11.5 (42%) for VC. Reductions in non-inflammatory lesions were -23.7 for TWIN low (54.9%) and -23.6 for TWIN high (53.3%) vs -13.7 (32.4%) for VC (all P < 0.001 vs VC). Results for TWIN were also numerically superior to E-BP and E-ATRA. All treatments were safe with comparable skin tolerability. The significant superiority of both combinations over VC and numerical superiority over E-BP and E-ATRA were achieved without an increase in adverse events or reduced skin tolerability.
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