Comparative Study of the Efficacy and Safety of the Ozonated Sunflower oil, Ketoconazole and Terbinafine in Patients with Dermatophytosis
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Background: Dermatophytosis are the leading cause of fungal infections worldwide. Objective: To compare the efficacy and safety of ozonated sunflower oil versus ketoconazole and terbinafine in patients with dermatophytosis. Methods: Multicenter Phase III study, it had an open, randomized, comparative design, with three parallel group to which ozonated sunflower oil was apply, or ketoconazole, or terbinafine, twice a day for 6 weeks. The effect on the clinical and mycological cure rate was prefix as the primary efficacy variable. The effect on treatment time to achieve cure was consider as a secondary efficacy variable. All data were analyzed by the intention-to-treat method. Results: The study included 300 patients of both sexes with a diagnosis of dermatophytosis, who were randomly distributed into three groups that received ozonated sunflower oil, or ketoconazole, or terbinafine, respectively. Treatment with ozonated sunflower oil produced a total clinical and mycological cure rate in 78% of patients, similar to ketoconazole (78%) and terbinafine (77%) treatment. Complete mycological cure was achieved in 87% of patients treated with ozonated sunflower oil, similar to ketoconazole (88%) and terbinafine (89%) treatments. Regarding the healing time, of the 233 patients with complete clinical cure, 10 patients (4.3%) were completely cure after 2 weeks of treatment, 58 patients (24.9%) after 4 weeks and 164 patients (70.4%) after 6 weeks. The treatments were safe and well tolerated. Conclusions: It's concluded that ozonated sunflower oil applied for six weeks showed comparable efficacy and safety with ketoconazole and terbinafine in patients with dermatophytosis.
Abstract
Background: Dermatophytosis are the leading cause of fungal infections worldwide. Objective: To compare the efficacy and safety of ozonated sunflower oil versus ketoconazole and terbinafine in patients with dermatophytosis. Methods: Multicenter Phase III study, it had an open, randomized, comparative design, with three parallel group to which ozonated sunflower oil was apply, or ketoconazole, or terbinafine, twice a day for 6 weeks. The effect on the clinical and mycological cure rate was prefix as the primary efficacy variable. The effect on treatment time to achieve cure was consider as a secondary efficacy variable. All data were analyzed by the intention-to-treat method. Results: The study included 300 patients of both sexes with a diagnosis of dermatophytosis, who were randomly distributed into three groups that received ozonated sunflower oil, or ketoconazole, or terbinafine, respectively. Treatment with ozonated sunflower oil produced a total clinical and mycological cure rate in 78% of patients, similar to ketoconazole (78%) and terbinafine (77%) treatment. Complete mycological cure was achieved in 87% of patients treated with ozonated sunflower oil, similar to ketoconazole (88%) and terbinafine (89%) treatments. Regarding the healing time, of the 233 patients with complete clinical cure, 10 patients (4.3%) were completely cure after 2 weeks of treatment, 58 patients (24.9%) after 4 weeks and 164 patients (70.4%) after 6 weeks. The treatments were safe and well tolerated. Conclusions: It's concluded that ozonated sunflower oil applied for six weeks showed comparable efficacy and safety with ketoconazole and terbinafine in patients with dermatophytosis.
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