Document Detail

Clinical and bacteriological evaluation of nadifloxacin 1% cream in patients with acne vulgaris: a double-blind, phase III comparison study versus erythromycin 2% cream.
MedLine Citation:
PMID:  16436342     Owner:  NLM     Status:  MEDLINE    
The aim of this double-blind, multinational, phase III study was to investigate the clinical and bacteriological efficacy of nadifloxacin 1% cream compared with erythromycin 2% cream in 474 European patients with predominantly inflamed slight-to-moderate acne vulgaris. During 12 weeks of treatment both nadifloxacin and erythromycin caused significant reduction in the number of inflamed papulo-pustular lesions (66.7% and 64.7%, respectively) and open and closed comedones. The microbiological evaluation showed a significant reduction of coagulase negative staphylococci (CNS) only in the nadifloxacin group, while Propionibacterium acnes was significantly reduced by both formulations. A significantly higher resistance and the extent of resistant of P. acnes and CNS against erythromycin compared to nadifloxacin were also evidenced. All adverse events reported were minor in both groups. This pivotal erythromycin-controlled study has demonstrated that nadifloxacin 1% cream was as efficacious and safe as erythromycin 2% and extremely low numbers of nadifloxacin-resistant microorganisms were detected in the treatment period.
Gerd Plewig; Keith T Holland; Pietro Nenoff
Publication Detail:
Type:  Clinical Trial, Phase III; Comparative Study; Journal Article; Multicenter Study    
Journal Detail:
Title:  European journal of dermatology : EJD     Volume:  16     ISSN:  1167-1122     ISO Abbreviation:  Eur J Dermatol     Publication Date:    2006 Jan-Feb
Date Detail:
Created Date:  2006-01-26     Completed Date:  2006-05-26     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  9206420     Medline TA:  Eur J Dermatol     Country:  France    
Other Details:
Languages:  eng     Pagination:  48-55     Citation Subset:  IM    
Klinik und Poliklinik für Dermatologie und Allergologie, Ludwig-Maximilians-Universität München, Frauenlobstr. 9-11, D-80337 München, Germany.
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MeSH Terms
Acne Vulgaris / drug therapy*,  microbiology*
Administration, Topical
Dose-Response Relationship, Drug
Double-Blind Method
Drug Administration Schedule
Drug Resistance, Bacterial
Erythromycin / therapeutic use*
Fluoroquinolones / therapeutic use*
Follow-Up Studies
Maximum Tolerated Dose
Microbial Sensitivity Tests
Quinolizines / therapeutic use*
Risk Assessment
Severity of Illness Index
Statistics, Nonparametric
Treatment Outcome
Reg. No./Substance:
0/Fluoroquinolones; 0/Quinolizines; 114-07-8/Erythromycin; 124858-35-1/nadifloxacin

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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