Therapeutic efficacy of topical OLEOZON® in patients suffering from onychomycosis

Mycoses. 2011 Sep;54(5):e272-7. doi: 10.1111/j.1439-0507.2010.01898.x. Epub 2010 May 17.


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.

Publication types

  • Comparative Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Administration, Topical
  • Adult
  • Aged
  • Antifungal Agents / administration & dosage*
  • Female
  • Humans
  • Ketoconazole / administration & dosage
  • Male
  • Middle Aged
  • Nails / pathology
  • Onychomycosis / drug therapy*
  • Plant Oils / administration & dosage*
  • Sunflower Oil
  • Treatment Outcome


  • Antifungal Agents
  • Plant Oils
  • Sunflower Oil
  • Ketoconazole