Prophylaxis of tinea pedis interdigitalis with bifonazole, 1% powder.
With the objectives of determining the effectiveness of bifonazole 1% powder in the prophylactic treatment of tinea pedis interdigitalis and its local tolerance, 200 patients who achieved clinical and mycological cure in another previous trial with bifonazole 1% gel, and who were also reliable in the compliance of the treatment, were included in this study. Informed consent was requested and obtained in each case. This was a multicenter, double-blind, controlled and comparative study of one group (100 patients) treated with bifonazole verum against another group (100 patients) treated with bifonazole placebo. The allocation to each group was performed by randomization. Bifonazole was applied once daily in the morning on both feet, after showering, and inside shoes; patients applied it again when changing shoes or socks during the day. Treatment lasted up to 6 months. During the treatment, patients were clinically and mycologically assessed once a month and, if it was necessary, when signs and/or symptoms of infection reappeared. The evaluation criteria were based on the reinfection, clinically and mycologically demonstrable, during the treatment. 29 patients abandoned the treatment. Reinfection was observed in 57 out of the 171 patients who finished the treatment, 47 reinfections occurred in the placebo group and the remaining 10 in the verum group. Tolerance was excellent, no side effects were observed in any patient.
D000328:Adult; D000935:Antifungal Agents / Q000627:therapeutic use*; D002986:Clinical Trials as Topic; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D007093:Imidazoles / Q000627:therapeutic use*; D008297:Male; D011208:Powders; D012008:Recurrence; D014008:Tinea Pedis / Q000517:prevention & control*; D014249:Trichophyton / Q000187:drug effects
D000935:Antifungal Agents; D007093:Imidazoles; D011208:Powders; C036596:bifonazole