Double blind clinical trial of the ageratina pichinchensis extract in the topical treatment of onychomycosis

Onychomycosis is a high-prevalence infectious disease that is usually treated with drugs administered chronically via the oral pathway, which produce important side effects. Ageratina pichinchensis, used in traditional medicine to treat dermatophytosis, has shown antifungal activity against Thrichophyton rubrum, and T. mentagrophytes. Clinically, a nail lacquer elaborated with the extract obtained from this plant showed similar rates of therapeutic effectiveness than 8% ciclopirox in patients with onichomycosis. OBJECTIVE: Evaluate two different concentrations of the standardized extract of A. pichinchensis in patients with mild to moderate onychomycosis. METHODOLOGY: By means of a randomly and comparative double blind clinical trial, 122 patients of either sex, within 19 and 65 years were included. A toenail sample was taken and submitted to direct microscopic identification before and after treatment. Two experimental groups were organized; group 1 was administered with a cosmetic nail lacquer formulation containing a 12.6% A. pichinchenis extract, while group 2 received an identical product containing 16.8% A. pichinchenis extract. All patients were treated and followed clinically for 6 months by means of monthly appointments. ANOVA and X² test were employed to identify differences between groups. Values of p<0.05 were considered significant. Results: 103 patients concluded the treatment. The therapeutic effectiveness exhibited by the 12.6% formulation was 67.2% while that of the 16.8% was 79.1%. Regarding clinical evolution analysis of results at the end of the treatment evidenced that the 16.8% concentration possesses higher therapeutic effectiveness (p=0.01).