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Clindamycin phosphate 1·2%–benzoyl peroxide 3·0% fixed‐dose combination gel has an effective and acceptable safety and tolerability profile for the treatment of acne vulgaris in Japanese patients: a phase III, multicentre, randomised, single‐blinded, active‐controlled, parallel‐group study
Author(s) -
Kawashima M.,
Hashimoto H.,
Alió Sáenz A.B.,
Ono M.,
Yamada M.
Publication year - 2015
Publication title -
british journal of dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.304
H-Index - 179
eISSN - 1365-2133
pISSN - 0007-0963
DOI - 10.1111/bjd.13265
Subject(s) - tolerability , medicine , benzoyl peroxide , acne , adverse effect , fixed dose combination , clinical endpoint , discontinuation , randomized controlled trial , gastroenterology , dermatology , chemistry , organic chemistry , polymerization , polymer
Summary Background A topical fixed‐dose clindamycin phosphate 1·2% and benzoyl peroxide 3·0% combination gel ( CLNP / BPO 3%) is known to be effective and safe in white people with acne. Objectives To evaluate the efficacy and safety of CLNP / BPO 3·0% topically applied once or twice daily vs. CLNP twice daily in Japanese patients with acne. Methods Eight hundred patients were randomized to receive CLNP / BPO 3·0% once daily, CLNP / BPO 3·0% twice daily or CLNP twice daily for 12 weeks. Primary endpoints were absolute change in number of total lesions ( TL s) from baseline to week 12 to demonstrate the superiority of CLNP / BPO 3·0% twice daily and noninferiority of CLNP / BPO 3·0% once daily vs. CLNP twice daily. Secondary endpoints were absolute and percentage changes in TL s, inflammatory lesions ( IL s), noninflammatory lesions (non‐ IL s) and Investigator's Static Global Assessment ( ISGA ) score. Safety assessments included adverse events ( AE s), laboratory tests, vital signs and local skin tolerability. Results Change in TL counts from baseline to week 12 for CLNP / BPO 3·0% twice daily was superior to CLNP twice daily (difference −11·0; P < 0·01); CLNP / BPO 3·0% once daily was not inferior to CLNP twice daily (difference −10·3; P < 0·01). Absolute and percentage reductions in TL , IL and non‐ IL counts and ISGA score were greater for CLNP / BPO 3·0% once or twice daily than for CLNP twice daily with significant differences seen from early on. Most AE s were mild or moderate. The incidence of adverse drug reactions was higher for CLNP / BPO 3·0% once (24·0%) or twice (35·1%) daily than for CLNP twice daily (9·0%). Conclusions Compared with CLNP twice daily, CLNP / BPO 3·0% once daily was more effective and CLNP / BPO 3·0% twice daily at least as effective, with an early onset of action and an acceptable safety and tolerability profile in Japanese patients.