J Pharm Pharmacogn Res 3(suppl. 1): S142, 2015
Proceedings of the 4th International Symposium on Pharmacology of Natural Products FAPRONATURA 2015 September 21st-25th, 2015; Cuban Society of Pharmacology. Topes de Collantes, Sancti Spiritus, Cuba.
PCT-50: PHARMACOLOGICAL EVIDENCES OF ANTIFUNGAL ACTION OF OZONIZED SUNFLOWER OIL OLEOZON®
Ledea O, Zamora Z, Falcón L, Fernández L, Fernández I, Calunga J, Menéndez S.
Introduction: Ozonized sunflower oil (OLEOZON®) is a national registered drug with a natural origin. It is obtained from the reaction between ozone and vegetable sunflower oil. The active pharmaceutical ingredients of this drug are peroxidic compounds with germicide action. The aim of this work is to summarize the results of two pre-clinical studies and three clinical trials that evaluate the antifungal properties of topical OLEOZON®. Material and Methods: The first preclinical experiments were related to the in vitro evaluation of the drug antifungal activity in three genera of fungus. It was followed by an in vivo study of dermatomicoses developed in rabbits. Two controlled randomized phase III clinical assays, comparing topical OLEOZON® with ketoconazole cream were developed. A phase IV clinical trial that included 2596 patients was also concluded. The efficacy was evaluated clinically and mycologically. Results: The in vitro antifungal activity obtained for OLEOZON® showed a dependence of the fungi genera. M. canis was more sensible and T. mentagrophytes was more resistant. The in vivo study showed that OLEOZON® was effective in the cure of the 100% of the rabbit’s in the experimental model. The evaluation of the phase III studies showed that OLEOZON® and ketoconazol treatments produced a complete clinical and mycological cure of patients, and a similar efficacy was obtained, with no significant differences between both groups. Patients were evaluated six months after the end of the treatment and no recurrence was observed in the OLEOZON® group. Conclusions: The phase IV study showed that OLEOZON® present an efficacy of 93% and no side effects or bacterial super-infections were observed. The preclinical action and the clinical efficacy and safety shown by topical OLEOZON® in the treatment of Tinea pedis justify the extension of this treatment in the national or international clinical practice because of its low cost and its remarkable germicidal action.
Citation Format: Ledea O, Zamora Z, Falcón L, Fernández L, Fernández I, Calunga J, Menéndez S (2015) Pharmacological evidences of antifungal action of ozonized sunflower oil Oleozon®. [Abstract]. In: Proceedings of the FAPRONATURA 2015; 2015 Sep 21-25; Topes de Collantes, Sancti Spiritus: CSF. J Pharm Pharmacogn Res 3(Suppl. 1): S142. Abstract nr PCT-50.