In this study, we observed the superior efficacy of nadifloxacin
1% cream+benzoyl peroxide 5% lotion compared to
nadifloxacin 1% cream+vehicle of benzoyl peroxide in the
treatment of mild to moderate facial acne vulgaris. The mean
percentage of reduction in inflammatory lesion was 22.08%
and 53.5% in the nadifloxacin and combination group
respectively. Combinations of topical antibiotics and benzoyl
peroxide or retinoids are the current standard regimens for
the treatment of mild to moderate acne vulgaris 1,2
they targeted multiple pathogenetic factors, greater and faster
efficacy were provided by these combinations. Development
of antibiotic-resistant P. acnes can also be prevented by these
combined topical treatments. At present, to our knowledge,
there has been no published study evaluating the combination
of nadifloxacin, a new topical antibiotic, with benzoyl
peroxide and comparing it to nadifloxacin alone.
Nadifloxacin, a new broad spectrum antibiotic was
licensed as acne medication in Turkey in 2008. A doubleblind,
vehicle-controlled study showed nadifloxacin cream
to be superior as clinically and bacteriologically to vehicle
7. A recent split face, double-blind vehicle controlled with
clinical and histological evaluation in 37 Korean patients ,
supported the previous data8. Plewig et al. noted similar
efficacy in reducing inflammatory lesion count with both
nadifloxacin 1% cream (66.7%) and erythromycin 2% cream
(64.7%) and superior efficacy of nadifloxacin in reducing P.
acnes in 474 participiants 9. A recently published Turkish
data verified the similar clinical efficacies of nadifloxacin 1%
cream and erythromycin 4% gel 10. In a study by Bojar et
al, erythromycin-resistant P. acnes were isolated from 27.9%
of erythromycin treated subjects, whereas no nadifloxacinresistant P. acnes were isolated from nadifloxacin treated
subjects after a 12 week-treatment 11. An in-vitro study
from Germany showed that P. acne has not developed
resistance to nadifloxacin during the last two years of use in
their country 12.
In this study, it has been shown that inflammatory and
noninflammatory lesions were reduced in a ratio of 22.08%
and 7.6% in the nadifloxacin group, 53.5% and 34.8% in
the nadifloxacin+benzoyl peroxide group respectively. The
efficacy of nadifloxacin cream in our study was lower than in
the previous studies. The efficacy of topical antibiotics such
as erythromycin and clindamycin has been documented in
a range of 35-70%. The efficacy of benzoyl peroxide alone
36-60% when combined with erythromycin or clindamycin
was 54-75% in well designed studies in the literature 13-19.
The efficacy of vehicle has also been found to be 5-35% in
these studies. In the light of these data, nadifloxacin in our
study can be assumed to have similar efficacy with vehicles.
The question was if nadifloxacin had any additive effect to
the results of our nadifloxacin+benzoyl peroxide group. A
four -armed study with an additional two treatment groups
(benzoyl peroxide and vehicle alone) would be more suitable
to answer this question. Unfortunately, we could not add
these groups to the study because of technical problems.
The treatment duration was lower in our study compared
to a previous study (8 vs 12 weeks respectively) 9. Topical
antibiotics are generally recommended for 8 weeks with the
limitation of maximum 12 weeks by the authors 1,2,20.
We observed maximum improvement with all treatment
regimens at week 2. There was no additional statistically
significant improvement after 2 weeks of nadifloxacin use.
We also provided the subject number as has been mentioned
in the study design. We believe that treatment duration and
the number of subjects were sufficient to show the difference
in efficacies in our study.
Although nadifloxacin is still superior to other antibiotics
in the rate of resistant pathogens, this fact might be due to its
very recent availability among the other acne medications in
the market 21. Judging from the perspective of effectiviness,
resistance and cost; the currently recommended therapy for
mild to moderate acne is to use topical retinoids, benzoyl
peroxide and/or antibiotics together 1,2,20.
In conclusion; although nadifloxacin has lower
efficacy when used alone, it might have an additive effect
in combination treatment of mild to moderate acne. Well
designed, comparative studies and cost-effectivity analysis
are still needed to include nadifloxacin as a specific agent.