Tolciclate in the local treatment of skin candidiases: a double-blind controlled multiclinic trial versus clotrimazole.
A controlled double-blind multiclinic trial comparing the activity and tolerability of tolciclate and clotrimazole on skin candidiasis was carried out in twenty-seven dermatological departments throughout Italy. Two hundred and seventy-eight patients were admitted to the trial. Tolciclate and clotrimazole 1% cream and lotion were applied twice a day for a mean time of about 3 weeks. Efficacy was evaluated weekly during the treatment both by clinical and mycological (culture) examinations. Culture baseline findings were positive for Candida sp in about 72% of cases; C. albicans was the most frequent species (41.5%) but also C. krusei and C. stellatoidea were isolated in a high percentage of cases. Tolciclate induced clinical cure or improvement in 89.7% of cases, mycological conversion in 73.6% with an overall efficacy (clinical + mycological) in 72.2%. Clotrimazole gave comparable results with, respectively, 95.7% of clinical cure or improvement, 75.3% of culture conversion and 77.6% of overall efficacy. The differences were small and statistically not significant. Tolerability was good and similar in both experimental groups.
D000293:Adolescent; D000328:Adult; D000368:Aged; D000935:Antifungal Agents / Q000627:therapeutic use*; D002177:Candidiasis / Q000188:drug therapy*; D002648:Child; D002675:Child, Preschool; D002986:Clinical Trials as Topic; D003022:Clotrimazole / Q000627:therapeutic use*; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000627:therapeutic use*; D007223:Infant; D008297:Male; D008875:Middle Aged; D012871:Skin Diseases / Q000188:drug therapy*; D013859:Thiocarbamates / Q000627:therapeutic use*
D000935:Antifungal Agents; D007093:Imidazoles; D013859:Thiocarbamates; D003022:Clotrimazole; C013305:tolciclate