Study on the sensitizing capacity of the new antimycotic sertaconazole in the treatment of cutaneous mycoses.

The sensitizing capacity of 7-chloro-3-[1-(2,4-dichlorophenyl)-2- (1H-imidazol-1-yl)ethoxy-methyl]benzo[b]thiophene (sertaconazole, FI-7045, CAS 99592-32-2) was studied in a randomized double-blind clinical trial in 78 atopical volunteers of both sexes. Sertaconazole in 2% dermatological cream form was compared with 5 other commercially available antimycotics (econazole, ketoconazole, bifonazole, clotrimazole and miconazole), using the excipient of the cream without sertaconazole and 2% sertaconazole in vaseline as controls. At the end of the trial, only miconazole showed a positive allergy (vesiculation) in two of the 78 individuals studied. The other substances did not demonstrate any sensitizing capacity, including sertaconazole and its excipient. This trial showed that sertaconazole in 2% dermatological cream form does not possess a sensitizing capacity for causing contact dermatitis which confirmed its excellent safety in topical use.

RCT Entities:   Population Interventions Outcomes