OXICONAZOLE CREAM VERSUS KETOCONAZOLE CRE AM - A PROSPECTIVE, RANDOMIZED, DOUBLE-BLIND MULTICENTRIC STUDY IN THE TREATMENT OF TINEA-CRURIS

Introduction. The aim of this study was to compare oxiconazole, 1 p. 1 00 cream, with ketoconazole, 2 p. 100 cream, applied once-daily, in th e treatment of tinea cruris. Patients and Methods. A prospective, rand omized, double-blind trial was performed in 8 dermatology departments on two parallel groups in patients having this type of mycosis confirm ed by mycological examination. Results. The efficacy was analyzed in 6 6 out of the 79 patients included in the study (36 patients treated wi th oxiconazole, 30 with ketoconazole). At Day 14, a first assessment w as made and 77.1 p. 100 of the patients treated with oxiconazole had b een cured; this result was significantly better (p < 0.05) than that o btained with ketoconazole (51.7 p. 100 of cured patients). At Day 21, after a further week of treatment, both treatments were efficient with statistically non-different results between the two groups: 97.2 p. 1 00 of the patients treated with oxiconazole, versus 86.7 p. 100 with k etoconazole. Thus, a greater rapidity of action of oxiconazole was obs erved. No correlation was detected between the ratio of cured patients and the duration of the mycosis. The safety was assessed in 74 patien ts. No adverse effects were reported for the patients treated with oxi conazole, whereas 9 patients treated with ketoconazole experienced con tact sensitization reactions and irritant skin reactions due to the ap plication of the product. The difference between the two groups of tre atment was statistically greatly significant (p < 0.001). Furthermore, acceptance of the drug on the part of the patient was better (p < 0.0 5) with oxiconazole. Discussion. After 3 weeks of topical treatment ox iconazole has revealed itself to be as efficient as ketoconazole, but it seems more rapidly efficient and better tolerated than ketoconazole .