Safety of Topical Oleozon® in the Treatment of Tinea Pedis: Phase IV Clinical Trial
S. Menéndez, L. Re, L. Falcón, M.B. Argote, I. Méndez, D. Fernández, B. Elías-Calle, M. Valero
SUMMARY - The efficacy of topical OLEOZON® against tinea pedis has already been demonstrated. The aim of the present study was to assess the adverse reactions associated with topical OLEOZON® in patients with tinea pedis. A multicenter, open, phase IV clinical trial was carried out. An adverse drug reaction report form specifying the reactions most commonly associated with topical OLEOZON® was designed. This study lasted three years. Patients were treated with topical OLEOZON® twice a day for six weeks. Of the total of 2596 patients admitted to the study, 2165 (83.4%) patients finished the treatment. The main cause of drop out of the 431 patients (16.6 %), was the scant attendance at the clinical evaluation. Six patients (0.3%) showed adverse reactions. The most frequently reported adverse reactions were skin burning sensation, pruritus and erythema of mild intensity. Skin burning sensation was considered, according to the causal relationship, as definite; pruritus and erythema were considered probable. Taking into account the number of patients that finished the treatment, an efficacy of 92.7% (2007 patients cured) was achieved. The favourable safety profile achieved with topical OLEOZON® in this study, together with its demonstrated efficacy and its low cost justify the extension of this treatment in clinical practice for patients with tinea pedis, particularly in developing countries.