PMID- 22134562
OWN - NLM
STAT- MEDLINE
DCOM- 20120406
LR  - 20131121
IS  - 1545-9616 (Print)
IS  - 1545-9616 (Linking)
VI  - 10
IP  - 12
DP  - 2011 Dec
TI  - Safety and efficacy of clindamycin phosphate 1.2%-benzoyl peroxide 3% fixed-dose 
      combination gel for the treatment of acne vulgaris: a phase 3, multicenter, 
      randomized, double-blind, active- and vehicle-controlled study.
PG  - 1382-96
AB  - BACKGROUND: Topical fixed-combination therapy containing 1% clindamycin as 1.2% 
      clindamycin phosphate (CLNP) and 3% benzoyl peroxide (BPO) is an effective 
      treatment for acne vulgaris (acne). OBJECTIVES: To demonstrate that the 
      combination of 1.2% CLNP with lower strength BPO (CLNP 1.2%-BPO 3%) in a gel 
      formulation is superior to each individual ingredient, CLNP 1.2% and BPO 3%, and 
      vehicle gel. METHODS: A total of 1,319 patients with acne, aged 12 years or 
      older, were enrolled and randomized (1:1:1:1) to receive CLNP 1.2%-BPO 3%, CLNP 
      1.2% gel, BPO 3% gel, or vehicle gel once-daily in a 12-week, multicenter, 
      double-blind, parallel-group, vehicle-controlled study. Subjects were evaluated 
      at baseline, weeks 2, 4, 8, and 12 or early termination. Assessment of efficacy 
      was evaluated using a six-point Investigator's Static Global Assessment (ISGA) 
      and Subject's Global Assessment (SGA) of acne severity and lesion counts 
      (inflammatory, non-inflammatory, and total). Safety assessments included skin 
      tolerability and adverse events (AEs). RESULTS: A greater proportion of subjects 
      who used CLNP 1.2%-BPO 3% gel (39%) had a two grade improvement in ISGA from 
      baseline to week 12 compared with CLNP 1.2% (25%; P<0.001), BPO 3% (30%; 
      P=0.016), and vehicle (18%; P<0.001). CLNP 1.2%- BPO 3% was superior to CLNP 1.2% 
      and vehicle alone in the absolute reduction from baseline to week 12 in all three 
      lesion types (P<0.001 all pair-wise comparisons). CLNP 1.2%-BPO 3% was superior 
      to BPO 3% alone in the absolute reduction from baseline to week 12 in 
      inflammatory (P=0.015) and total (P=0.032) lesion counts. The incidence of 
      product-related AEs was low and similar in all study groups (1% with CLNP 
      1.2%-BPO 3%, 2% with CLNP 1.2%, 2% with BPO 3%, and 2% with vehicle). Local 
      tolerability assessments showed similar minimal changes from baseline to week 12 
      in all study groups. CONCLUSION: CLNP 1.2%-BPO 3% gel provides superior efficacy 
      to improve ISGA score and reduce inflammatory and total lesion counts compared 
      with the individual active ingredients (CLNP 1.2% and BPO 3%) and vehicle, while 
      maintaining a highly favorable safety and tolerability profile similar to BPO 3% 
      alone.
FAU - Eichenfield, Lawrence F
AU  - Eichenfield LF
AD  - Rady Children's Hospital, San Diego, CA 92123-4204, USA. leichenfield@rchsd.org
FAU - Alio Saenz, Alessandra B
AU  - Alio Saenz AB
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
PL  - United States
TA  - J Drugs Dermatol
JT  - Journal of drugs in dermatology : JDD
JID - 101160020
RN  - 0 (Anti-Bacterial Agents)
RN  - 0 (Dermatologic Agents)
RN  - 0 (Drug Combinations)
RN  - 0 (Gels)
RN  - 0 (clindamycin phosphate benzoyl peroxide combination)
RN  - 3U02EL437C (Clindamycin)
RN  - W9WZN9A0GM (Benzoyl Peroxide)
SB  - IM
MH  - Acne Vulgaris/*drug therapy
MH  - Adolescent
MH  - Adult
MH  - Anti-Bacterial Agents/adverse effects/*therapeutic use
MH  - Belize
MH  - Benzoyl Peroxide/adverse effects/*therapeutic use
MH  - Canada
MH  - Child
MH  - Clindamycin/adverse effects/*therapeutic use
MH  - Dermatologic Agents/adverse effects/*therapeutic use
MH  - Double-Blind Method
MH  - Drug Combinations
MH  - Female
MH  - Gels
MH  - Humans
MH  - Male
MH  - Middle Aged
MH  - Treatment Outcome
MH  - United States
MH  - Young Adult
EDAT- 2011/12/03 06:00
MHDA- 2012/04/07 06:00
CRDT- 2011/12/03 06:00
PHST- 2011/12/03 06:00 [entrez]
PHST- 2011/12/03 06:00 [pubmed]
PHST- 2012/04/07 06:00 [medline]
PST - ppublish
SO  - J Drugs Dermatol. 2011 Dec;10(12):1382-96.