OBJECTIVE: To assess efficacy and speed of action of a monodose sertaconazole vaginal suppository administered as a single treatment or combined with sertaconazole cream applied to the vulvar area. METHODS: This prospective, multicentric, randomised open study was conducted on 77 women with vulvovaginal candidiasis confirmed by mycological examination. They were either treated with one sertaconazole monodose vaginal suppository only (group O) or treated with the suppository combined with sertaconazole cream applied to the vulvar area for 7 days (group OC). The patients who were not clinically cured at D7 received a second phase of treatment. RESULTS:Clinical cure rates were higher in group OC than in group O at D7 (76% versus 68%), and D14 (100% versus 80%). The efficacy on symptoms was faster in group OC, with 78% of the patients relieved of pruritus as early as D2 versus 61% in group O, although these differences were not significant. Clinical local tolerance was very good, with 95% of patients not experiencing any local side effects. CONCLUSION: When candidiasis is both vulvar and vaginal, the combination of sertaconazole cream with a monodose sertaconazole vaginal suppository tends to improve clinical cure at D7 and D14 and to relieve more patients as early as D2 than the vaginal suppository used as a single treatment.
RCT Entities:
OBJECTIVE: To assess efficacy and speed of action of a monodose sertaconazole vaginal suppository administered as a single treatment or combined with sertaconazole cream applied to the vulvar area. METHODS: This prospective, multicentric, randomised open study was conducted on 77 women with vulvovaginal candidiasis confirmed by mycological examination. They were either treated with one sertaconazole monodose vaginal suppository only (group O) or treated with the suppository combined with sertaconazole cream applied to the vulvar area for 7 days (group OC). The patients who were not clinically cured at D7 received a second phase of treatment. RESULTS: Clinical cure rates were higher in group OC than in group O at D7 (76% versus 68%), and D14 (100% versus 80%). The efficacy on symptoms was faster in group OC, with 78% of the patients relieved of pruritus as early as D2 versus 61% in group O, although these differences were not significant. Clinical local tolerance was very good, with 95% of patients not experiencing any local side effects. CONCLUSION: When candidiasis is both vulvar and vaginal, the combination of sertaconazole cream with a monodose sertaconazole vaginal suppository tends to improve clinical cure at D7 and D14 and to relieve more patients as early as D2 than the vaginal suppository used as a single treatment.
Authors: W Mendling; K Friese; I Mylonas; E-R Weissenbacher; J Brasch; M Schaller; P Mayser; I Effendy; G Ginter-Hanselmayer; H Hof; O Cornely; M Ruhnke Journal: Geburtshilfe Frauenheilkd Date: 2015-04 Impact factor: 2.915