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首页> 外文期刊>Cutis >A North American study of adapalene-benzoyl peroxide combination gel in the treatment of acne.
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A North American study of adapalene-benzoyl peroxide combination gel in the treatment of acne.

机译：北美对阿达帕林-过氧化苯甲酰复合凝胶治疗痤疮的研究。

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A fixed-dose combination gel with adapalene 0.1% and benzoyl peroxide (BPO) 2.5% recently has been developed for the treatment of acne vulgaris. In this multicenter, randomized, double-blind, parallel-group, active- and vehicle-controlled study conducted at 60 centers in the United States, Puerto Rico, and Canada, we assessed the efficacy and safety of adapalene-BPO combination gel in comparison with adapalene and BPO monotherapies as well as the gel vehicle. Participants with moderate facial acne vulgaris (rated 3 on the 5-point investigator global assessment of acne severity scale) were recruited and randomized to receive once-daily treatment with adapalene-BPO combination gel, adapalene monotherapy, BPO monotherapy, or gel vehicle for 12 weeks. They were assessed for success rate (the percentage of participants with investigator global assessment of acne severity rated clear or almost clear) and percentage change in inflammatory lesion (IL), noninflammatory lesion (NIL), and total lesion counts. Of the 1668 participants enrolled, 1429 (85.7%) completed the study. At study end point, adapalene-BPO combination gel showed a significantly higher success rate (P < or = .006) and a greater percentage reduction in all acne lesion counts (P < or = .017) compared with the other treatment groups. A significant early treatment effect of adapalene-BPO combination gel at week 1 compared with adapalene monotherapy and vehicle also was observed for all lesion count reductions (P<.001). The safety of adapalene-BPO combination gel was comparable with adapalene and BPO monotherapies and vehicle. In a large clinical trial, the adapalene-BPO fixed-dose combination gel has shown superiority in efficacy compared with adapalene and BPO monotherapies and vehicle, with an early onset of efficacy and a good safety profile.
机译：最近开发了一种固定剂量的联合用凝胶，其中含有0.1％的阿达帕林和2.5％的过氧化苯甲酰（BPO），用于治疗寻常型痤疮。在美国，波多黎各和加拿大的60个中心进行的这项多中心，随机，双盲，平行组，主动和媒介对照研究中，我们比较了阿达帕林-BPO组合凝胶的疗效和安全性阿达帕林和BPO单一疗法以及凝胶载体。招募中度面部痤疮（在5分研究者痤疮严重程度总体评估中为3级）的参与者，并随机接受阿达帕林-BPO联合凝胶，阿达帕林单一疗法，BPO单一疗法或凝胶媒介物每日一次治疗12周。评估他们的成功率（研究人员对痤疮严重程度进行总体评估的参与者的百分等级为“清晰”或“几乎清晰”）以及炎性病变（IL），非炎性病变（NIL）和总病变计数的变化百分比。在1668名参与者中，有1429名（85.7％）完成了研究。在研究终点，与其他治疗组相比，阿达帕林-BPO组合凝胶显示出显着更高的成功率（P <或= .006），并且所有痤疮病变计数降低的百分比更大（P <或= .017）。与阿达帕林单药治疗和媒介物相比，阿达帕林-BPO复合凝胶在第1周的早期治疗效果显着（P <.001）。阿达帕林-BPO组合凝胶的安全性与阿达帕林和BPO单一疗法和媒介物相当。在一项大型临床试验中，与阿达帕林和BPO单一疗法和赋形剂相比，阿达帕林-BPO固定剂量组合凝胶已显示出优越的疗效，并且具有较早的疗效和良好的安全性。

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