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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

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

Nobukazu Hayashi, Ichiro Kurokawa, Obukohwo Siakpere, Akira Endo, Toshiki Hatanaka, Masahiro Yamada, Makoto Kawashima

J Dermatol. 2018 Aug;45(8):951-962.

PMID: 29905384

Abstract:

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.

Chemicals Related in the Paper:

Catalog Number	Product Name	Structure	CAS Number	Price
AP24729962-A	Clindamycin Phosphate		24729-96-2	Price

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