Abstract:
Adult acne vulgaris affects up to 43-51% of individuals. While there are numerous treatment options for acne including topical, oral, and energy-based approaches, benzoyl peroxide (BPO) is a popular over the counter (OTC) treatment. Although BPO monotherapy has a long history of efficacy and safety, it suffers from several disadvantages, most notably, skin irritation, particularly for treatment naïve patients. In this prospective, randomized, controlled, split-face study, we evaluated the comparative efficacy, safety, and tolerability of a novel 3-step azelaic acid, salicylic acid, and graduated retinol regimen versus a common OTC BPO-based regimen over 12 weeks. A total of 37 adult subjects with self-reported mild to moderate acne vulgaris were recruited. A total of 21 subjects underwent a 2-week washout period and completed the full study with 3 dropping out due to product irritation from the BPO routine, and 13 being lost to follow-up. Detailed tolerability surveys were conducted at Week 4. Additional surveys on tolerability and product preferences were collected monthly, at Week 4, Week 8, and Week 12. A blinded board-certified dermatologist objectively scored the presence and type of acne lesions (open or closed comedones, papules, pustules, nodules, and cysts) at baseline, Week 4, Week 8, and Week 12. Patients photographed themselves and uploaded the images using personal mobile phones. Detailed Week 4 survey results showed across 25 domains of user-assessed product performance, the novel routine outperformed the BPO routine in 19 (76%) which included domains in preference (e.g. \"I would use this in the future) and performance (\"my skin improved\" and \"helped my acne clear up faster\"). Users of the novel routine reported less facial redness, itching, and burning, though differences did not reach statistical significance. In terms of efficacy, both products performed similarly, reducing total acne lesions by 36% (novel routine) and 40% (BPO routine) by Week 12. Overall, accounting for user preferences and tolerability the novel routine was more preferred than the BPO routine in 79% of domains (22/28). Differences in objective acne lesion reduction were not statistically significant (p = 0.97). In a randomized split-face study, a 3-step azelaic acid, salicylic acid, and graduated retinol regimen delivered similar acne lesion reduction, fewer user dropouts, greater user tolerability, and higher use preference compared to a 3-step BPO routine based in a cohort of participants with mild-to-moderate acne vulgaris.
摘要:
成人寻常痤疮影响多达43-51%的个体。虽然痤疮有许多治疗选择,包括局部治疗,口服,和基于能源的方法,过氧化苯甲酰(BPO)是一种流行的非处方药(OTC)治疗。尽管BPO单一疗法具有悠久的疗效和安全性,它有几个缺点,最值得注意的是,皮肤刺激,特别是对于初治患者。在这个前景中,随机化,控制,分面研究,我们评估了比较疗效,安全,和新的三步壬二酸的耐受性,水杨酸,和分级视黄醇方案与基于常规OTCBPO的方案在12周内的比较。总共招募了37名自我报告为轻度至中度寻常痤疮的成年受试者。共有21名受试者经历了2周的洗脱期,并完成了完整的研究,其中3名因BPO常规产品刺激而退出。和13失去了后续行动。在第4周进行详细的耐受性调查。每月收集有关耐受性和产品偏好的其他调查,在第4周、第8周和第12周。一位盲人委员会认证的皮肤科医生客观地对痤疮病变的存在和类型进行了评分(开放性或封闭式粉刺,丘疹,脓疱,结节,和囊肿)在基线,第4周、第8周和第12周。患者自己拍照并使用个人手机上传图像。第4周的详细调查结果显示了用户评估的产品性能的25个领域,这项新的常规方案在19项(76%)中优于BPO常规方案,其中包括优先领域(例如,“我将来会使用它)和性能(“我的皮肤得到改善”和“帮助我的痤疮更快地清除”).新程序的用户报告面部发红较少,瘙痒,燃烧,尽管差异没有达到统计学意义。就功效而言,两种产品表现相似,到第12周,痤疮总病变减少36%(新常规)和40%(BPO常规)。总的来说,考虑到用户偏好和耐受性,在79%的领域中,新的常规方案比BPO常规方案更优选(22/28).客观痤疮病变减少的差异无统计学意义(p=0.97)。在一项随机分面研究中,三步壬二酸,水杨酸,和分级的视黄醇方案提供了类似的痤疮病变减少,更少的用户退出,更高的用户耐受性,与基于轻度至中度寻常痤疮参与者的3步BPO常规相比,使用偏好更高。