title: 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.
abstract: 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.
  
  
  CONCLUSIONS
  CDP/BPO gel demonstrated superior efficacy over CDP gel along with acceptable safety and tolerability in Chinese patients with mild to moderate acne.
  NCT01915732.
authors.affiliation: Department of Dermatology, Huashan Hospital, Fudan University, Shanghai, China.
authors.forename: J H
authors.initials: JH
authors.lastname: Xu
authors.affiliation: Hunan Key Laboratory of Medical Epigenomics, Department of Dermatology, Second Xiangya Hospital, Central South University, Changsha, China.
authors.forename: Q J
authors.initials: QJ
authors.lastname: Lu
authors.affiliation: Department of Dermatology, Third Xiangya Hospital, Central South University, Changsha, China.
authors.forename: J H
authors.initials: JH
authors.lastname: Huang
authors.affiliation: Department of Dermatology, Southwest Hospital, Third Military Medical University, Chongqing, China.
authors.forename: F
authors.initials: F
authors.lastname: Hao
authors.affiliation: Department of Dermatology, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences, Peking Union Medical College, Beijing, China.
authors.forename: Q N
authors.initials: QN
authors.lastname: Sun
authors.affiliation: Department of Dermatology, The First Affiliated Hospital of Zhejiang University School of Medicine, Hangzhou, China.
authors.forename: H
authors.initials: H
authors.lastname: Fang
authors.affiliation: Department of Dermatology, Changhai Hospital, Second Military Medical University, Shanghai, China.
authors.forename: J
authors.initials: J
authors.lastname: Gu
authors.affiliation: Department of Dermatology, Guangdong General Hospital, Guangzhou, China.
authors.forename: X Q
authors.initials: XQ
authors.lastname: Dong
authors.affiliation: Department of Dermatology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China.
authors.forename: J
authors.initials: J
authors.lastname: Zheng
authors.affiliation: Department of Dermatology, The First Affiliated Hospital of Nanjing Medical University, Nanjing, China.
authors.forename: D
authors.initials: D
authors.lastname: Luo
authors.affiliation: Department of Dermatology, The Second Hospital of Jilin University, Changchun, China.
authors.forename: F Q
authors.initials: FQ
authors.lastname: Li
authors.affiliation: Department of Dermatology, Xijing Hospital, Fourth Military Medical University, Xi'an, China.
authors.forename: G
authors.initials: G
authors.lastname: Wang
authors.affiliation: Institute of Dermatology, Chinese Academy of Medical Science and Peking Union Medical College, Nanjing, China.
authors.forename: H
authors.initials: H
authors.lastname: Gu
authors.affiliation: Shandong Provincial Institute of Dermatology and Venereology, Provincial Academy of Medical Science, Jinan, Shandong, China.
authors.forename: H Q
authors.initials: HQ
authors.lastname: Tian
authors.affiliation: Department of Dermatology, General Hospital of Guangzhou Military Command of PLA, Guangzhou, China.
authors.forename: H L
authors.initials: HL
authors.lastname: Yang
authors.affiliation: Department of Dermatology, Sun Yat-sen Memorial Hospital, Guangzhou, China.
authors.forename: L Y
authors.initials: LY
authors.lastname: Xi
authors.affiliation: Department of Dermatology, Zhongshan Hospital, Fudan University, Shanghai, China.
authors.forename: M
authors.initials: M
authors.lastname: Li
authors.affiliation: Department of Dermatology, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, China.
authors.forename: M
authors.initials: M
authors.lastname: Zheng
authors.affiliation: Department of Dermatology, Peking University First Hospital, Beijing, China.
authors.forename: Y
authors.initials: Y
authors.lastname: Wu
authors.affiliation: Department of Dermatology, Union Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China.
authors.forename: Y T
authors.initials: YT
authors.lastname: Tu
authors.affiliation: Department of Dermatology, Beijing Chao-Yang Hospital, Capital Medical University, Beijing, China.
authors.forename: Y L
authors.initials: YL
authors.lastname: He
authors.affiliation: Department of Dermatology, Air Force General Hospital, Beijing, China.
authors.forename: G
authors.initials: G
authors.lastname: Zhao
authors.affiliation: Department of Dermatology, Zhongnan Hospital, Wuhan University, Wuhan, China.
authors.forename: W X
authors.initials: WX
authors.lastname: Sheng
authors.affiliation: GlaxoSmithKline, Pudong, Shanghai, China.
authors.forename: J
authors.initials: J
authors.lastname: Li
authors.affiliation: Stiefel, a GlaxoSmithKline Company, NC, USA.
authors.forename: A G
authors.initials: AG
authors.lastname: Hamedani
mesh_terms: D000152:Acne Vulgaris / Q000188:drug therapy*; D000287:Administration, Topical; D000293:Adolescent; D000328:Adult; D001585:Benzoyl Peroxide / Q000008:administration & dosage*; D002648:Child; D002681:China; D002981:Clindamycin / Q000008:administration & dosage*; D005260:Female; D005782:Gels; D006801:Humans; D008297:Male; D008875:Middle Aged; D016037:Single-Blind Method; D055815:Young Adult
chemical_list: D005782:Gels; D002981:Clindamycin; D001585:Benzoyl Peroxide