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Abstract：
BACKGROUND: Acne vulgaris, a chronic inflammatory condition, is associated with significant physical and psychosocial burden. Since 2019, three new topical agents for acne vulgaris have been approved in the USA and Canada. We performed a systematic review and meta-analysis to compare the efficacy between twice-daily clascoterone cream 1%, once-daily trifarotene 0.005% cream, and once-daily tazarotene 0.045% lotion for acne treatment.
METHODS: Randomized controlled trials (RCTs) comparing clascoterone, trifarotene, or tazarotene with vehicle in patients with moderate-to-severe acne were identified from a systematic literature review and included in a meta-analysis. Primary outcomes were percentage reduction in inflammatory and noninflammatory lesion count (ILC and NILC, respectively) and treatment success rate (≥ 2-grade improvement in Investigator\'s Global Assessment or Evaluator\'s Global Severity Score and a rating of clear or almost clear) at week 12. DerSimonian and Laird random-effects models with the inverse variance method were used to calculate the mean difference (MD) for percentage reduction in ILC and NILC, and odds ratios (ORs) for the rate of treatment success.
RESULTS: Six Phase 3 RCTs were included in the meta-analysis. The analyses showed robust differences favoring the interventions for ILC (MD: - 11.5; 95% confidence interval [CI]: - 14.39, - 8.62), NILC (MD: - 12.25; 95% CI: - 15.21, - 9.29), and treatment success rate (OR: 2.14; 95% CI: 1.81, 2.53). No differences were observed between clascoterone, trifarotene, and tazarotene for ILC (MD: - 12.8, - 11.2, and - 10.1, respectively), NILC (MD: - 11.6, - 13.9, and - 12.8, respectively), or treatment success rate (OR: 2.9, 1.9, and 2.1, respectively (all P > 0.05).
CONCLUSIONS: No significant differences in efficacy were observed between clascoterone, trifarotene, and tazarotene after 12 weeks of treatment in patients with moderate-to-severe acne. Differences in application frequency and safety profile should also be taken into consideration when making treatment decisions.
METHODS: Randomized controlled trials (RCTs) comparing clascoterone, trifarotene, or tazarotene with vehicle in patients with moderate-to-severe acne were identified from a systematic literature review and included in a meta-analysis. Primary outcomes were percentage reduction in inflammatory and noninflammatory lesion count (ILC and NILC, respectively) and treatment success rate (≥ 2-grade improvement in Investigator\'s Global Assessment or Evaluator\'s Global Severity Score and a rating of clear or almost clear) at week 12. DerSimonian and Laird random-effects models with the inverse variance method were used to calculate the mean difference (MD) for percentage reduction in ILC and NILC, and odds ratios (ORs) for the rate of treatment success.
RESULTS: Six Phase 3 RCTs were included in the meta-analysis. The analyses showed robust differences favoring the interventions for ILC (MD: - 11.5; 95% confidence interval [CI]: - 14.39, - 8.62), NILC (MD: - 12.25; 95% CI: - 15.21, - 9.29), and treatment success rate (OR: 2.14; 95% CI: 1.81, 2.53). No differences were observed between clascoterone, trifarotene, and tazarotene for ILC (MD: - 12.8, - 11.2, and - 10.1, respectively), NILC (MD: - 11.6, - 13.9, and - 12.8, respectively), or treatment success rate (OR: 2.9, 1.9, and 2.1, respectively (all P > 0.05).
CONCLUSIONS: No significant differences in efficacy were observed between clascoterone, trifarotene, and tazarotene after 12 weeks of treatment in patients with moderate-to-severe acne. Differences in application frequency and safety profile should also be taken into consideration when making treatment decisions.
摘要：
背景：寻常痤疮，慢性炎症,与重大的身体和心理负担有关。自2019年以来，三种新的寻常痤疮外用药物已在美国和加拿大获得批准。我们进行了系统评价和荟萃分析，以比较每天两次的1％的Clascoterone乳膏之间的疗效。每日一次三法罗汀0.005%乳膏，和每天一次他扎罗汀0.045%洗剂用于痤疮治疗。
方法：随机对照试验（RCT）比较了克拉维酮，trifarotene,或他扎罗汀与媒介物在中度至重度痤疮患者中的应用从系统文献综述中确定,并纳入荟萃分析.主要结果是炎性和非炎性病变计数的减少百分比（ILC和NILC，分别）和治疗成功率（研究者的全球评估或评估者的全球严重程度评分和明确或几乎明确的评级中≥2级改善）在第12周。使用逆方差方法的DerSimonian和Laird随机效应模型来计算ILC和NILC减少百分比的平均差（MD），和治疗成功率的比值比(ORs)。
结果：6个3期随机对照试验纳入meta分析。分析显示，有利于ILC干预措施的强劲差异(MD：-11.5；95%置信区间[CI]：-14.39，-8.62)，NILC（MD：-12.25；95%CI：-15.21，-9.29），治疗成功率（OR：2.14；95%CI：1.81，2.53）。没有观察到的差异,trifarotene,和他扎罗汀用于ILC(MD：分别为-12.8、-11.2和-10.1)，NILC（MD：分别为-11.6，-13.9和-12.8），或治疗成功率（OR分别为2.9、1.9和2.1（均P>0.05）。
结论：在疗效上没有观察到显著差异，trifarotene,和他扎罗汀治疗12周后中度至重度痤疮患者。在做出治疗决定时，还应考虑应用频率和安全性方面的差异。
方法：随机对照试验（RCT）比较了克拉维酮，trifarotene,或他扎罗汀与媒介物在中度至重度痤疮患者中的应用从系统文献综述中确定,并纳入荟萃分析.主要结果是炎性和非炎性病变计数的减少百分比（ILC和NILC，分别）和治疗成功率（研究者的全球评估或评估者的全球严重程度评分和明确或几乎明确的评级中≥2级改善）在第12周。使用逆方差方法的DerSimonian和Laird随机效应模型来计算ILC和NILC减少百分比的平均差（MD），和治疗成功率的比值比(ORs)。
结果：6个3期随机对照试验纳入meta分析。分析显示，有利于ILC干预措施的强劲差异(MD：-11.5；95%置信区间[CI]：-14.39，-8.62)，NILC（MD：-12.25；95%CI：-15.21，-9.29），治疗成功率（OR：2.14；95%CI：1.81，2.53）。没有观察到的差异,trifarotene,和他扎罗汀用于ILC(MD：分别为-12.8、-11.2和-10.1)，NILC（MD：分别为-11.6，-13.9和-12.8），或治疗成功率（OR分别为2.9、1.9和2.1（均P>0.05）。
结论：在疗效上没有观察到显著差异，trifarotene,和他扎罗汀治疗12周后中度至重度痤疮患者。在做出治疗决定时，还应考虑应用频率和安全性方面的差异。
