[Clinical results with the antimycotic agent ciclopiroxolamine (author's transl)]. / Klinische Ergebnisse mit dem Antimykotikum Ciclopiroxolamin.

After a brief account of the laboratory and animal studies of 6-cyclohexyl-1-hydroxy-4-methyl-2(1H)-pyridone, 2-aminoethanol salt (ciclopiroxolamine, Cic, Hoe 296, Batrafen) and an outline of previous clinical trials, the results of a double-blind trial with Cic cream and clotrimazole cream are reported, together with those of a large-scale trial of Cic cream in consulting practice. Used for the treatment of skin disorders diagnosed as mycoses, the effectiveness rate of Cic cream ranged from 79 to 98%, depending on the criterion used for assessment. The double-blind trial did not reveal any significant differences between its effect and that of clotrimazole cream. The incidence of side-effects can be regarded as minimal.

[Open clinical study on the efficacy and tolerance of ciclopiroxolamine in vulvovaginal candidosis (author's transl)]. / Offene Studie zur Wirksamkeit und Verträglichkeit von Ciclopiroxolamin bei vulvovaginaler Candidose.

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.