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

Author(s): Romaguera C, Herrero E, Marquez M, Torres J, Ortiz JA

Affiliation(s): Dermatology Department, Hospital Sagrado Corazon, Medical School, University of Barcelona, Spain.

Publication date & source: 1992-05, Arzneimittelforschung., 42(5A):754-6.

Publication type: Clinical Trial; Randomized Controlled Trial

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.

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