TOPICAL QUINOLONE NADIFLOXACIN (OPC-7251) IN BACTERIAL SKIN-DISEASE -CLINICAL-EVALUATION IN A MULTICENTER OPEN TRIAL AND IN-VITRO ANTIMICROBIOLOGICAL SUSCEPTIBILITY TESTING

Nadifloxacin (OPC-7251) is a topical fluoroquinolone which inhibits th e configuration of supercoiled DNA by DNA gyrase. Previous studies hav e shown the efficacy of this topical agent in acne vulgaris. The purpo se of this open study (clinical phase II) was to investigate the clini cal efficacy and tolerability of nadifloxacin 1% cream applied topical ly in 101 patients with impetigo, secondarily infected wounds, follicu litis and sycosis vulgaris, and impetiginized dermatitis. Efficacy was assessed by counts of lesions and crusts, evaluation of objective and subjective symptoms, and microbiological isolation and identification of aerobic and anaerobic bacteria at baseline and at the end (day 7, or 14, respectively) of the study. The antibacterial activity of nadif loxacin against isolated bacterial strains was also tested in vitro by an agar dilution technique. Nadifloxacin treatment led to a statistic ally significant reduction in the degree of erythema, exudation, swell ing, pain, pruritus, erosion, crusts and scaling, and eradication of c ausative bacteria was achieved. Three patients reported adverse effect s (itching, erythema and inflammatory swelling each in one patient). P hysicians' judgement on efficacy and tolerability was 'very good' or ' good' in 92% of the patients. Nadifloxacin was active against all aero bic and anaerobic isolates. Causative Staphylococcus aureus, beta-hemo lytic streptococci and coagulase-negative staphylococci were eradicate d in 83%, 100% and 68% of patients, respectively. Minimum inhibitory c oncentrations were 0.05 - 0.02 mu g/ml for S. aureus, 0.05 - 3.13 mu g /ml for coagulase-negative staphylococci, 0.05 - 0.78 mu g/ml for beta -hemolytic streptococci and 0.05 - 0.78 mu g/ml for Propionibacterium ames. All organisms isolated from the lesions before and at the end of the study were highly sensitive and none was resistant to nadifloxaci n. In summary, nadifloxacin, a topical quinolone, is a new alternative for topical antibiotic treatment in bacterial skin infection.