Comparative Study of the Efficacy and Safety of theOzonated Sunflower oil, Ketoconazole and Terbinafinein Patients with Dermatophytosis
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
- Gladys Jiménez Rivero (ORCID: https://orcid.org/0000-0003-4934-6224)
- Elvia Nelemi Santos González (ORCID: https://orcid.org/0000-0001-7336-1681)
- Sarahí Mendoza Castaño (ORCID: https://orcid.org/0000-0001-6483-0466)
- Rolando Uranga (ORCID: https://orcid.org/0000-0002-9362-9064)
- Olaine Regla Gray Lovio (ORCID: https://orcid.org/0000-0001-6089-805X)
- Juana del Valle Rodríguez
- Eva Aizpurúa González (ORCID: https://orcid.org/0009-0004-6185-5034)
- Maylen Rodríguez Ordaz (ORCID: https://orcid.org/0000-0002-8692-0929)
- Yaniris Lorenzo (ORCID: https://orcid.org/0009-0008-4537-3974)
- Marlenys Pérez Bruzón (ORCID: https://orcid.org/0000-0002-7928-627X)
- Janaina de Fatima Saraiva Cardoso (ORCID: https://orcid.org/0009-0003-4137-3778)
- Edward Wong (ORCID: https://orcid.org/0000-0001-6855-0365)
- Julio César Fernández Travieso (ORCID: https://orcid.org/0000-0001-8144-4129)
- M Moreira (ORCID: https://orcid.org/0000-0003-3780-2712)
- Marisa Hernández (ORCID: https://orcid.org/0000-0002-1457-9717)
- Lázara Alacán Pérez (ORCID: https://orcid.org/0000-0002-9650-2966)
- Yenney Reyes Nuñez (ORCID: https://orcid.org/0000-0001-7784-0268)
- Ada Bermúdez Sori (ORCID: https://orcid.org/0009-0006-1812-3748)
- Lisandra Linares Luna (ORCID: https://orcid.org/0009-0001-3870-8755)
- Ana Labrada Carballo (ORCID: https://orcid.org/0000-0002-7937-7251)
- Yanay Fernández Domínguez (ORCID: https://orcid.org/0009-0005-7971-2346)
- Yeni González Liriano (ORCID: https://orcid.org/0000-0002-1800-1867)
Institutions
- Cuban Neuroscience Center (CU)
- Instituto de Oncología y Radiobiología (CU)
- Finlay Institute (CU)
Publication Details
- Journal
- Journal of Mycology and Infection
- Published
- 2024-09-30
- DOI
- https://doi.org/10.17966/jmi.2024.29.3.98
- Primary Topic
- Medical and Biological Ozone Research
- Type
- article
- Field-Weighted Citation Impact
- 0.00