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

Abstract

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.

• Authors: C Romaguera, E Herrero, M Márquez, J Torres, J A Ortiz
• Journal: Arzneimittel-Forschung (Arzneimittelforschung) Vol. 42 Issue 5A Pg. 754-6 (May 1992) ISSN: 0004-4172 [Print] Germany
• PMID: 1627200 (Publication Type: Clinical Trial, Comparative Study, Journal Article, Randomized Controlled Trial)

Chemical References

• Antifungal Agents
• Imidazoles
• Thiophenes
• sertaconazole
• Miconazole

Topics

• Adolescent
• Adult
• Antifungal Agents (adverse effects, therapeutic use)
• Dermatomycoses (drug therapy)
• Double-Blind Method
• Drug Hypersensitivity (pathology)
• Female
• Humans
• Imidazoles (adverse effects, therapeutic use)
• Male
• Miconazole (adverse effects, therapeutic use)
• Thiophenes (adverse effects, therapeutic use)