Comparative Study of the Efficacy and Safety of the Ozonated Sunflower oil, Ketoconazole and Terbinafine in Patients with Dermatophytosis
Year: 2024
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
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.
Authors: Lazara Alacán Pérez, Julio César Fernández Travieso, Evelyn Anie González Pla, Yeni González Liriano, Olaine Regla Gray Lovio, Elizabeth Sanler Wong, Maylen Rodríguez Ordaz, Yanela Rodríguez Lorenzo, Marlenys Pérez Bruzón, Jose Alejandro Díaz Cardoso, Ada Bermudez Sori, Juana del Valle Rodríguez, Elvia Nelemi Santos González, Lisandra Linares Luna, Ana Labrada Carballo, Yenney Reyes Nuñez, Yanay Fernández Domínguez, Sarahí Mendoza Castaño, Manuel Eduardo Cordero Hernández, Gladys Jiménez Rivero, Marta Lidia Barrera Moreira, Rolando Uranga Piña
Language: English
Topic: Nail Diseases and Treatments
Subfield: Epidemiology
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W4403563791