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.
Romaguera
C
C
Dermatology Department, Hospital Sagrado Corazón, Medical School, University of Barcelona, Spain.
Herrero
E
E
Márquez
M
M
Torres
J
J
Ortiz
J A
JA
D000293:Adolescent; D000328:Adult; D000935:Antifungal Agents / Q000009:adverse effects* / Q000627:therapeutic use; D003881:Dermatomycoses / Q000188:drug therapy*; D004311:Double-Blind Method; D004342:Drug Hypersensitivity / Q000473:pathology*; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000009:adverse effects* / Q000627:therapeutic use; D008297:Male; D008825:Miconazole / Q000009:adverse effects / Q000627:therapeutic use; D013876:Thiophenes / Q000009:adverse effects* / Q000627:therapeutic use
D000935:Antifungal Agents; D007093:Imidazoles; D013876:Thiophenes; C061131:sertaconazole; D008825:Miconazole