J Mycol Infect.  2024 Sep;29(3):98-107. 10.17966/JMI.2024.29.3.98.

Comparative Study of the Efficacy and Safety of the Ozonated Sunflower oil, Ketoconazole and Terbinafine in Patients with Dermatophytosis

• Pérez LA
• Travieso JCF
• Pla EAG
• Liriano YG
• Lovio ORG
• Wong ES
• Ordaz MR
• Lorenzo YR
• Bruzón MP
• Cardoso JAD
• Sori AB
• Rodríguez JdV
• González ENS
• Luna LL
• Carballo AL
• Nuñez YR
• Domínguez YF
• Hernández MEC
• Castaño SM
• Rivero GJ
• Moreira MLB
• Piña RU

• KMID: 2563173
• DOI: http://doi.org/10.17966/JMI.2024.29.3.98

Abstract

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.

Keyword

Dermatophytes; Ketoconazole; Ozonated sunflower oil; Terbinafine; Tinea pedis