Safety and efficacy of a new imidazole fungicide, Sertaconazole, in the treatment of fungal vulvo-vaginitis: a comparative study using Fluconazole and Clotrimazole

Background: Sertaconazole is a new imidazole fungicide introduced for vulvo-vaginal candidiasis. It has an azole group with benzothiophene that inhibits biosynthesis of ergosterol and brings about a massive leak of cytoplasm with consequent fungal cell death. Objective: Assess the safety and efficacy of Sertaconazole in the treatment of fungal vulvo-vaginitis for comparison with Fluconazole and Clotrimazole. Subjects and methods: One-hundred eighty-eight outpatients with fungal vulvo-vaginitis were recruited at Siriraj Hospital, Thailand between August 31, 2004 and January 30, 2006. The patients were given Sertaconazole, Fluconazole, or Clotrimazole, and received vaginal swab and culture for fungus at seventh and 28th days after treatment. Results: Out of 188 cases, 177 cases were followed-up completely. Sertaconazole group included 66 cases where 35 cure, 20 fail, and 7 recurrent cases. Fluconazole group included 60 cases and had 37 cure, six fail, and 20 recurrence cases. Clotrimazole group included 55 cases and had 32 cure, nine fail and 11 recurrent cases. There were risk factors of fungal vulvo-vaginitis, including frequent micturition and small toilet shower flushing. Conclusion: Sertaconazole had similar effectiveness and less side-effect as compared with Fluconazole and Clotrimazole. It appeared to work well with lowest recurrence.