Effectiveness and tolerability of a standardized extract from Ageratina pichinchensis on patients with tinea pedis: an explorative pilot study controlled with ketoconazole.

Ageratina pichinchensis has been used for many years in Mexican traditional medicine for the treatment of superficial mycosis. Previous studies have demonstrated the antifungal effectiveness of a hexane extract from aerial parts of this plant on in vitro cultures of Candida albicans, Aspergillium niger, Trichophyton mentagrophytes, and Trichophyton rubrum. To compare the effectiveness and tolerability of A. pichinchensis with ketoconazole in patients with the clinical and mycological diagnosis of tinea pedis, we carried out a double-blind pilot study. The experimental group was treated topically with a cream containing A. pichinchensis standardized extract (10 %), while the control group was administered a similarly colored cream containing 2 % ketoconazole. All patients were clinically followed weekly for 4 weeks. By means of a mycological examination (direct microscopic detection), the mycological diagnosis of tinea pedis was performed. This technique was also used for evaluating the mycological effectiveness at the end of treatment. A total of 120 patients were included, 60 in each treatment group. Of these, 97 patients were included in the statistical analysis, 51 from the experimental group and 46 controls. The remainder of the patients withdrew from the study due to non-medical causes. Clinical effectiveness was reached in 80.3 and 76 %, while therapeutic success was achieved in 80.3 and 71.7 % of the experimental and control groups, respectively. There were no statistical differences between groups (P = 0.31). Our results suggest the effectiveness and tolerability of a standardized extract from A. pichinchensis in treatment of patients with tinea pedis.