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

• Published in: Journal of the European Academy of Dermatology and Venereology Vol. 30; no. 7; pp. 1176 - 1182
• Main Authors: Xu, J.H., Lu, Q.J., Huang, J.H., Hao, F., Sun, Q.N., Fang, H., Gu, J., Dong, X.Q., Zheng, J., Luo, D., Li, F.Q., Wang, G., Gu, H., Tian, H.Q., Yang, H.L., Xi, L.Y., Li, M., Zheng, M., Wu, Y., Tu, Y.T., He, Y.L., Zhao, G., Sheng, W.X., Li, J., Hamedani, A.G.
• Format: Journal Article
• Language: English
• Published: England Blackwell Publishing Ltd 01.07.2016
• Subjects: Acne Vulgaris - drug therapy; Administration, Topical; Adolescent; Adult; Benzoyl Peroxide - administration & dosage; Child; China; Clindamycin - administration & dosage; Female; Gels; Humans; Male; Middle Aged; Single-Blind Method; Young Adult
• ISSN: 0926-9959; 1468-3083
• DOI: 10.1111/jdv.13622

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. Clinical Trials.gov number: NCT01915732