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A double-blind clinical trial of fenticonazole (2%) spray versus naftifine (1%) spray in patients with cutaneous mycoses.

Author(s): Leiste D, Braun W, Fegeler W, Fegeler K, Stary A, Ruping KW, Klaschka F, Colli E, Sartani A

Affiliation(s): Klinikum Steglitz, Berlin, Federal Republic of Germany.

Publication date & source: 1989, Curr Med Res Opin., 11(9):567-75.

Publication type: Clinical Trial; Multicenter Study; Randomized Controlled Trial

A multi-centre, double-blind trial was carried out in 100 patients with cutaneous mycotic infections, confirmed by direct microscopy and/or culture, to compare the efficacy and tolerability of spray formulations of 2% fenticonazole and 1% naftifine. On entry, patients were allocated at random to receive once daily topical applications of one or other drug over a period of 2 to 4 weeks, treatment being stopped when patients had recovered or substantially improved. Clinical and mycological assessments were made before (baseline), at weekly intervals during treatment and, if possible, 2 to 3 weeks after the end of treatment (drug-free period). Treatment was continued for 19.25 days with fenticonazole and 19.62 days with naftifine. All patients had positive mycological findings on entry. The most frequently isolated pathogens were dermatophytes, mainly Trichophyton rubrum; however, Candida albicans was present in 33.3% of patients in the fenticonazole group and in 20.8% of those treated with naftifine. At the end of treatment, only 3 (6.3%) and 5 (10.4%) patients, respectively, of the 48 patients assessed in each group still had positive mycological findings. Assessments of symptoms indicated comparable, significant improvement in both groups, and at the end of treatment the overall opinion of doctors and patients was that about 90% of patients were cured or greatly improved. The end of the drug-free period evaluation showed that, of the patients assessed as cured or greatly improved at the end of treatment, only 1 (3.2%) patient who had received fenticonazole and 2 (6.3%) who had received naftifine were confirmed mycologically as having relapsed.(ABSTRACT TRUNCATED AT 250 WORDS)

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