Therapeutic efficacy of topical OLEOZON® in patients suffering from onychomycosis.
The results of the use of ozonised sunflower oil (OLEOZON(®)) in the treatment of onychomycosis, based on its known antimycotic action and good skin tolerance, by means of a controlled randomised phase III assay are presented. A total of 400 outpatients were randomly divided into two groups: experimental, treated with topical OLEOZON(®), two times per day and control, treated also two times per day, with ketoconazole cream 2%, for 3 months. A patient was considered cured when the sick nails regained the normal colour, growth and thickness, with a negative mycological study. In the experimental group, a regression of signs was achieved from the first month of treatment, while in the control group, it was obtained after the third month of treatment. All patients treated with OLEOZON(®) had improvement in their condition (9.5%) or were cured (90.5%). However, in the control group, only 13.5% of patients were cured, 27.5% improved and 59% remained the same, with significant differences between both the groups. After 1 year of follow-up, experimental and control groups presented 2.8% and 44.4% of relapses, respectively. Topical OLEOZON(®) demonstrated effectiveness in the treatment of onychomycosis, superior to that of ketoconazole. No side effects were observed.
Menéndez
Silvia
S
Ozone Research Center, National Center for Scientific Research, Havana, Cuba. silviamenendez@infomed.sld.cu
Falcón
Leopoldina
L
Maqueira
Yordana
Y
D000287:Administration, Topical; D000328:Adult; D000368:Aged; D000935:Antifungal Agents / Q000008:administration & dosage*; D005260:Female; D006801:Humans; D007654:Ketoconazole / Q000008:administration & dosage; D008297:Male; D008875:Middle Aged; D009262:Nails / Q000473:pathology; D014009:Onychomycosis / Q000188:drug therapy*; D010938:Plant Oils / Q000008:administration & dosage*; D000074242:Sunflower Oil; D016896:Treatment Outcome
D000935:Antifungal Agents; D010938:Plant Oils; D000074242:Sunflower Oil; D007654:Ketoconazole