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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
Author(s) -
Hayashi Nobukazu,
Kurokawa Ichiro,
Siakpere Obukohwo,
Endo Akira,
Hatanaka Toshiki,
Yamada Masahiro,
Kawashima Makoto
Publication year - 2018
Publication title -
the journal of dermatology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.9
H-Index - 65
eISSN - 1346-8138
pISSN - 0385-2407
DOI - 10.1111/1346-8138.14497
Subject(s) - acne , benzoyl peroxide , adapalene , tolerability , medicine , fixed dose combination , adverse effect , clindamycin , dermatology , clinical endpoint , randomized controlled trial , antibiotics , chemistry , biochemistry , organic chemistry , polymerization , polymer
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 .