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2017 ; 44
(6
): 635-643
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gab.com Text
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English Wikipedia
Open-label, randomized, multicenter, phase III study to evaluate the safety and
efficacy of benzoyl peroxide gel in long-term use in patients with acne vulgaris:
A secondary publication
#MMPMID28150367
Kawashima M
; Nagare T
; Katsuramaki T
J Dermatol
2017[Jun]; 44
(6
): 635-643
PMID28150367
show ga
An open-label, randomized, multicenter study was conducted to evaluate the safety
and efficacy of long-term use of 2.5% and 5% benzoyl peroxide (BPO) gels
administrated once daily for 52 weeks to Japanese patients with acne vulgaris.
The efficacy of the study drugs was evaluated by counting inflammatory lesions
and non-inflammatory lesions. Safety was evaluated based on adverse events, local
skin tolerability scores and laboratory test values. In total, 458 subjects were
included in the efficacy and safety analyses. The total lesion count, the
efficacy end-point, was similarly changed both in the 2.5% and 5% BPO groups over
the course of the study. The median rates of reduction from baseline to week 12
were approximately 65%. Thereafter, the counts were maintained at a reduced level
without increasing until week 52. The median rates at week 52 were approximately
80%. Similar trends were observed for inflammatory and non-inflammatory lesion
counts. Bacteriological evaluation indicated similar distribution of the minimum
inhibitory concentration of each of the antibacterial drugs against
Propionibacterium acnes between the values at baseline and at week 52, suggesting
that long-term use did not result in changes in the drug sensitivity. The
incidence of adverse events was 84.0% in the 2.5% BPO group and 87.2% in the 5%
BPO group. Many of the adverse events occurred within the first month and were
mild or moderate in severity and transient. The results suggest that both 2.5%
and 5% BPO gels are effective and safe for long-term treatment of patients with
acne vulgaris.