Department of Dermatology, Huashan Hospital, Fudan University, Shanghai, China.
Hunan Key Laboratory of Medical Epigenomics, Department of Dermatology, Second Xiangya Hospital, Central South University, Changsha, China.
J Eur Acad Dermatol Venereol. 2016 Jul;30(7):1176-82. doi: 10.1111/jdv.13622. Epub 2016 Apr 13.
Acne vulgaris affects up to 54% of Chinese adolescents. Combination therapy has become the recommended standard of care for acne.
The aim of this study was to compare the efficacy and safety of clindamycin (1%) and benzoyl peroxide (5%) (CDP/BPO) gel once daily vs. clindamycin (1%) (CDP) monotherapy gel twice daily in Chinese patients with mild to moderate acne.
1020 patients (aged 12-45 years) with mild to moderate acne were randomized (1 : 1); 1016 patients were treated with CDP/BPO (n = 500) or CDP (n = 516) for a 12-week treatment period. Efficacy assessments were performed at baseline, and at weeks 1, 2, 4, 8 and 12; and primarily included change in total lesion count (inflammatory and non-inflammatory lesions), and proportion of patients with a minimum 2-grade improvement in Investigator's Static Global Assessment (ISGA) score. Patient safety and local tolerability were also evaluated.
Patients in CDP/BPO group showed a greater per cent reduction in total lesion count compared with patients in CDP group at week 12 (delta = -0.05; 95% CI = -0.09, -0.02; P = 0.003); statistically significant reduction in lesion count was noted as early as week 1 and continued through week 12. A greater proportion of patients in CDP/BPO group showed a ≥2-grade improvement in ISGA score at week 12 compared with CDP group (30.2% vs. 22.7%; P = 0.018). Overall, the incidence of adverse events (AEs) was higher in the CDP/BPO group (14.4%) than in the CDP group (7.9%); the most commonly reported events were generally related to application site reactions (erythema, pruritus and swelling). Incidence of drug-related AEs was 8.6% in CDP/BPO group and 1.2% in CDP group. Both groups showed trends towards reduction in investigator and subject rated local tolerability scores.
CDP/BPO gel demonstrated superior efficacy over CDP gel along with acceptable safety and tolerability in Chinese patients with mild to moderate acne.
NCT01915732.
寻常痤疮影响多达 54%的中国青少年。联合治疗已成为痤疮的推荐标准治疗方法。
本研究旨在比较每日一次克林霉素（1%）和过氧化苯甲酰（5%）（CDP/BPO）凝胶与每日两次克林霉素（1%）（CDP）单药凝胶治疗中国轻中度痤疮患者的疗效和安全性。
1020 例（年龄 12-45 岁）轻中度痤疮患者随机（1:1）；1016 例患者接受 CDP/BPO（n=500）或 CDP（n=516）治疗，治疗期为 12 周。在基线、第 1、2、4、8 和 12 周进行疗效评估；主要包括总病变计数（炎症性和非炎症性病变）的变化，以及研究者静态全球评估（ISGA）评分至少改善 2 级的患者比例。还评估了患者安全性和局部耐受性。
与 CDP 组相比，CDP/BPO 组患者在第 12 周时总病变计数的百分比降低更大（差值=-0.05；95%CI=-0.09，-0.02；P=0.003）；从第 1 周开始就注意到病变计数的显著减少，并持续到第 12 周。与 CDP 组相比，CDP/BPO 组在第 12 周时达到 ISGA 评分至少改善 2 级的患者比例更高（30.2%比 22.7%；P=0.018）。总体而言，CDP/BPO 组的不良事件（AE）发生率（14.4%）高于 CDP 组（7.9%）；最常见的报告事件通常与应用部位反应（红斑、瘙痒和肿胀）有关。CDP/BPO 组药物相关 AE 的发生率为 8.6%，CDP 组为 1.2%。两组研究者和受试者评价的局部耐受性评分均呈下降趋势。
在中国轻中度痤疮患者中，与 CDP 凝胶相比，CDP/BPO 凝胶显示出更好的疗效，且安全性和耐受性可接受。
NCT01915732。
