PMID- 27075705 OWN - NLM STAT- MEDLINE DCOM- 20170426 LR - 20170426 IS - 1468-3083 (Electronic) IS - 0926-9959 (Linking) VI - 30 IP - 7 DP - 2016 Jul TI - A multicentre, randomized, single-blind comparison of topical clindamycin 1%/benzoyl peroxide 5% once-daily gel versus clindamycin 1% twice-daily gel in the treatment of mild to moderate acne vulgaris in Chinese patients. PG - 1176-82 LID - 10.1111/jdv.13622 [doi] AB - BACKGROUND: Acne vulgaris affects up to 54% of Chinese adolescents. Combination therapy has become the recommended standard of care for acne. OBJECTIVE: 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. METHODS: 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. RESULTS: 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. CONCLUSION: CDP/BPO gel demonstrated superior efficacy over CDP gel along with acceptable safety and tolerability in Chinese patients with mild to moderate acne. GOV NUMBER: NCT01915732. CI - (c) 2016 European Academy of Dermatology and Venereology. FAU - Xu, J H AU - Xu JH AD - Department of Dermatology, Huashan Hospital, Fudan University, Shanghai, China. FAU - Lu, Q J AU - Lu QJ AD - Hunan Key Laboratory of Medical Epigenomics, Department of Dermatology, Second Xiangya Hospital, Central South University, Changsha, China. FAU - Huang, J H AU - Huang JH AD - Department of Dermatology, Third Xiangya Hospital, Central South University, Changsha, China. FAU - Hao, F AU - Hao F AD - Department of Dermatology, Southwest Hospital, Third Military Medical University, Chongqing, China. FAU - Sun, Q N AU - Sun QN AD - Department of Dermatology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, China. FAU - Fang, H AU - Fang H AD - Department of Dermatology, The First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China. FAU - Gu, J AU - Gu J AD - Department of Dermatology, Changhai Hospital, Second Military Medical University, Shanghai, China. FAU - Dong, X Q AU - Dong XQ AD - Department of Dermatology, Guangdong General Hospital, Guangzhou, China. FAU - Zheng, J AU - Zheng J AD - Department of Dermatology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China. FAU - Luo, D AU - Luo D AD - Department of Dermatology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China. FAU - Li, F Q AU - Li FQ AD - Department of Dermatology, The Second Hospital of Jilin University, Changchun, China. FAU - Wang, G AU - Wang G AD - Department of Dermatology, Xijing Hospital, Fourth Military Medical University, Xi'an, China. FAU - Gu, H AU - Gu H AD - Institute of Dermatology, Chinese Academy of Medical Science and Peking Union Medical College, Nanjing, China. FAU - Tian, H Q AU - Tian HQ AD - Shandong Provincial Institute of Dermatology and Venereology, Provincial Academy of Medical Science, Jinan, Shandong, China. FAU - Yang, H L AU - Yang HL AD - Department of Dermatology, General Hospital of Guangzhou Military Command of PLA, Guangzhou, China. FAU - Xi, L Y AU - Xi LY AD - Department of Dermatology, Sun Yat-sen Memorial Hospital, Guangzhou, China. FAU - Li, M AU - Li M AD - Department of Dermatology, Zhongshan Hospital, Fudan University, Shanghai, China. FAU - Zheng, M AU - Zheng M AD - Department of Dermatology, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China. FAU - Wu, Y AU - Wu Y AD - Department of Dermatology, Peking University First Hospital, Beijing, China. FAU - Tu, Y T AU - Tu YT AD - Department of Dermatology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China. FAU - He, Y L AU - He YL AD - Department of Dermatology, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China. FAU - Zhao, G AU - Zhao G AD - Department of Dermatology, Air Force General Hospital, Beijing, China. FAU - Sheng, W X AU - Sheng WX AD - Department of Dermatology, Zhongnan Hospital, Wuhan University, Wuhan, China. FAU - Li, J AU - Li J AD - GlaxoSmithKline, Pudong, Shanghai, China. FAU - Hamedani, A G AU - Hamedani AG AD - Stiefel, a GlaxoSmithKline Company, NC, USA. LA - eng SI - ClinicalTrials.gov/NCT01915732 PT - Journal Article PT - Multicenter Study PT - Randomized Controlled Trial DEP - 20160413 PL - England TA - J Eur Acad Dermatol Venereol JT - Journal of the European Academy of Dermatology and Venereology : JEADV JID - 9216037 RN - 0 (Gels) RN - 3U02EL437C (Clindamycin) RN - W9WZN9A0GM (Benzoyl Peroxide) SB - IM MH - Acne Vulgaris/*drug therapy MH - Administration, Topical MH - Adolescent MH - Adult MH - Benzoyl Peroxide/*administration & dosage MH - Child MH - China MH - Clindamycin/*administration & dosage MH - Female MH - Gels MH - Humans MH - Male MH - Middle Aged MH - Single-Blind Method MH - Young Adult EDAT- 2016/04/15 06:00 MHDA- 2017/04/27 06:00 CRDT- 2016/04/15 06:00 PHST- 2015/09/30 00:00 [received] PHST- 2016/01/06 00:00 [accepted] PHST- 2016/04/15 06:00 [entrez] PHST- 2016/04/15 06:00 [pubmed] PHST- 2017/04/27 06:00 [medline] AID - 10.1111/jdv.13622 [doi] PST - ppublish SO - J Eur Acad Dermatol Venereol. 2016 Jul;30(7):1176-82. doi: 10.1111/jdv.13622. Epub 2016 Apr 13.