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Adapalene 0.1% ( ADA ) with clindamycin phosphate 1.2% ( CLNP ;  ADA  +  CLNP ) and the fixed‐dose combination containing  CLNP  and benzoyl peroxide 3% ( CLNP / BPO  3%) are strongly recommended for the early treatment of acne vulgaris in Japan. Here, we compare the early efficacy and safety of  CLNP / BPO  3% with Japanese standard topical use of  ADA  +  CLNP  in the treatment of acne vulgaris. In this phase  IV , multicenter study, 351 patients were randomized to receive  CLNP / BPO  3% or  ADA  +  CLNP  for 12 weeks. The primary end‐point was percentage change from baseline in total lesion ( TL ) counts at week 2. Secondary end‐points included the percentage change from baseline in  TL , inflammatory and non‐inflammatory lesion ( IL  and non‐ IL ) counts, Investigator's Static Global Assessment ( ISGA ), quality of life (QoL [Skindex‐16]) and patient preference. Local tolerability scores and adverse events were also recorded.  CLNP / BPO  3% provided a significantly greater percentage reduction from baseline in  TL  compared with  ADA  +  CLNP  at week 2, and week 4. Compared with  ADA  +  CLNP ,  CLNP / BPO  3% was superior at reducing  IL  (but not non‐ IL ) over weeks 2–12, was more effective at improving patient QoL and  ISGA , and scored higher in patient‐preference assessments. Both treatments were well tolerated; adverse drug reactions occurred more frequently in patients receiving  ADA  +  CLNP  (37%) than in those receiving  CLNP / BPO  3% (17%). In conclusion,  CLNP / BPO  3% showed greater efficacy for the early treatment of acne vulgaris in Japan, with a more favorable safety profile compared with  ADA  +  CLNP .

the journal of dermatology

Clindamycin phosphate 1.2%/benzoyl peroxide 3% fixed‐dose combination gel versus topical combination therapy of adapalene 0.1% gel and clindamycin phosphate 1.2% gel in the treatment of acne vulgaris in Japanese patients: A multicenter, randomized, investigator‐blind, parallel‐group study