PMID- 25040180
OWN - NLM
STAT- MEDLINE
DCOM- 20151110
LR  - 20150209
IS  - 1365-2133 (Electronic)
IS  - 0007-0963 (Linking)
VI  - 172
IP  - 2
DP  - 2015 Feb
TI  - 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.
PG  - 494-503
LID - 10.1111/bjd.13265 [doi]
AB  - 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 (TLs) 
      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 TLs, inflammatory 
      lesions (ILs), noninflammatory lesions (non-ILs) and Investigator's Static Global 
      Assessment (ISGA) score. Safety assessments included adverse events (AEs), 
      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 AEs 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.
CI  - (c) 2014 British Association of Dermatologists.
FAU - Kawashima, M
AU  - Kawashima M
AD  - Department of Dermatology, Tokyo Women's Medical University, Tokyo, Japan.
FAU - Hashimoto, H
AU  - Hashimoto H
FAU - Alio Saenz, A B
AU  - Alio Saenz AB
FAU - Ono, M
AU  - Ono M
FAU - Yamada, M
AU  - Yamada M
LA  - eng
PT  - Clinical Trial, Phase III
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20150107
PL  - England
TA  - Br J Dermatol
JT  - The British journal of dermatology
JID - 0004041
RN  - 0 (Anti-Bacterial Agents)
RN  - 0 (Dermatologic Agents)
RN  - 0 (Drug Combinations)
RN  - 0 (Gels)
RN  - 3U02EL437C (Clindamycin)
RN  - EH6D7113I8 (clindamycin phosphate)
RN  - W9WZN9A0GM (Benzoyl Peroxide)
SB  - IM
MH  - Acne Vulgaris/*drug therapy
MH  - Administration, Cutaneous
MH  - Adolescent
MH  - Adult
MH  - Anti-Bacterial Agents/*administration & dosage/adverse effects
MH  - Benzoyl Peroxide/*administration & dosage/adverse effects
MH  - Child
MH  - Clindamycin/administration & dosage/adverse effects/*analogs & derivatives
MH  - Dermatologic Agents/*administration & dosage/adverse effects
MH  - Drug Administration Schedule
MH  - Drug Combinations
MH  - Female
MH  - Gels
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Single-Blind Method
MH  - Treatment Outcome
MH  - Young Adult
EDAT- 2014/07/22 06:00
MHDA- 2015/11/11 06:00
CRDT- 2014/07/22 06:00
PHST- 2014/07/01 00:00 [accepted]
PHST- 2014/07/22 06:00 [entrez]
PHST- 2014/07/22 06:00 [pubmed]
PHST- 2015/11/11 06:00 [medline]
AID - 10.1111/bjd.13265 [doi]
PST - ppublish
SO  - Br J Dermatol. 2015 Feb;172(2):494-503. doi: 10.1111/bjd.13265. Epub 2015 Jan 7.