[Open clinical study on the efficacy and tolerance of ciclopiroxolamine in vulvovaginal candidosis (author's transl)].
In an open multicentre trial, the local activity and tolerance of an aqueous cream with 1% 6-cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridone, 2-aminoethanol salt (ciclopiroxolamine, Cic, Hoe 296, Batrafen) in vulvovaginal candidosis was investigated. On 7 consecutive days (on the average), a 5 cm3 amount of cream was inserted into the vagina once a day. Where necessary, the cream was also applied to the vulva. In 149 cases, the sexual partner was treated. The study initially comprised 235 patients suffering from clinically and mycologically diagnosed vulvovaginal candidosis. The results of 220 subjects could be evaluated. Judging from the cases in which data were complete, the cultural proofs at the 1st (2nd) control after treatment were negative in 90.9% (89.1%) of cases and the microscopic proofs were negative in 93.6% (92.3%). Healing was noticed in 89.9% of the cases. No indication of recurrence was observed. Side-effects, which in general were very mild, were recorded in 3.2% of the cases. Treatment was stopped in one patient.
D000293:Adolescent; D000328:Adult; D000368:Aged; D000935:Antifungal Agents / Q000009:adverse effects / Q000627:therapeutic use*; D002181:Candidiasis, Vulvovaginal / Q000188:drug therapy* / Q000382:microbiology; D000077768:Ciclopirox; D002986:Clinical Trials as Topic; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011728:Pyridones / Q000009:adverse effects / Q000627:therapeutic use*
D000935:Antifungal Agents; D011728:Pyridones; D000077768:Ciclopirox
Offene Studie zur Wirksamkeit und Verträglichkeit von Ciclopiroxolamin bei vulvovaginaler Candidose.