Dermatomycoses of the glabrous skin : a double-blind, randomised, comparative trial of sertaconazole 2% cream once daily versus vehicle.

OBJECTIVE: The aim of this multicentre, double-blind, vehicle-controlled study was to investigate the safety and efficacy of once-daily topical application of sertaconazole 2% cream compared with corresponding vehicle cream in the treatment of patients with tinea of glabrous skin. PATIENTS AND METHODS: A total of 400 patients were recruited at seven investigational sites; 144 patients in the intent-to-treat (ITT) population and 127 in the per-protocol (PP) population were treated for 3 weeks with either sertaconazole 2% once daily or corresponding vehicle cream. To evaluate therapeutic efficacy and safety, microscopic examination of native preparations, mycological cultures, and clinical assessment of the state of the lesion (objective and subjective monitoring of symptoms) were analysed after 3 weeks of treatment.
RESULTS: Based on these parameters, in both the PP and ITT populations, sertaconazole cream 2% once daily induced a higher cure rate than the vehicle cream: 82% of the PP population (vehicle cream control 61%; p = 0.014) and 83% of the ITT population (vehicle cream control 59%; p = 0.003) randomised to sertaconazole with a previously positive mycological culture showed negative culture results after sertaconazole treatment. No statistically significant differences were observed regarding frequency and severity of adverse effects.
CONCLUSION: These data indicate that treatment of superficial dermatomycoses with sertaconazole 2% cream for 3 weeks is efficient and safe. The once-daily application regimen may improve patient compliance, which has been shown to be of exceptional importance for successful treatment of dermatomycoses of the glabrous skin.

RCT Entities:   Population Interventions Outcomes