Analysis of the results of an Italian multicenter study of the efficacy and tolerability of fluconazole 100 mg/day in the treatment of cutaneous mycoses

The paper analyses data from 240 patients with dermatomycoses (T. corporis, T. cruris, T. pedis, T. unguium, P. versicolor) and others enrolled in a multicentre open study. A summary of the clinical and mycological efficacy and tolerability data of fluconazole 100 mg/day is presented. A total of 218 patients were evaluated for efficacy. The main clinical diagnoses were T. corporis (89 patients), T. cruris (53 patients) and T. pedis (46 patients). The main mycological diagnoses were the following: T. rubrum (67 cases), M. canis (41 cases), T. mentagrophytes (35 cases) and E. floccosum (32 cases). Clinical cure was observed in 179 patients (82.1%) and improvement in 21 patients (9.6%) whilst treatment failed in 11 cases (5.0%) and 5 patients (2.3%) had a relapse (data were missing for 2 patients). The average treatment duration was 20.2 days (±7.7). Clinical symptoms (erythema, itching, burning, scaling, exudation) significantly improved after 7 days of treatment in all diagnoses groups. Total disappearance of symptoms was observed in 78 to 97% of cases evaluated at the end of treatment, 93-97% and 95-99% of cases evaluated at the follow-up visits scheduled 4 and 8 weeks after the end of treatment, respectively. Eradication of the baseline pathogen was achieved in 189 patients (86.7%) whilst persistence, superinfection and relapse were reported in 20 (9.2%), 3 (1.4%) and 2 (0.9%) subjects, respectively (data missing for 4 patients). Clinical efficacy was combined with a low incidence of adverse events (12.5%), usually transient and mild and that led to treatment discontinuation in only 2 cases. Adverse events were primarily related to the gastrointestinal system (10 patients, 4.1%).