Clinical trial to compare the effectiveness of two concentrations of the Ageratina pichinchensis extract in the topical treatment of onychomycosis.

UNLABELLED

The plant species Ageratina pichinchensis has been used, for many years, in Mexican traditional medicine for the treatment of superficial mycosis.

AIM OF THE STUDY

This study compared the therapeutic effectiveness and tolerability of two concentrations of the standardized extract from Ageratina pichinchensis (12.6 and 16.8%) on patients with clinical and mycological diagnosis of mild and moderate onychomycosis.

MATERIALS AND METHODS

Two identical phytopharmaceuticals (containing the standardized extract from Ageratina pichinchensis) in nail lacquer solution for topical administration were evaluated in a double-blind clinical trial. Treatments were administered for 6 months to patients distributed in two groups.

RESULTS AND DISCUSSION

Of 122 patients who agreed to participate in the study, 103 (84.4%) concluded the treatment. The therapeutic effectiveness exhibited by the 12.6% Ageratina pichinchensis extract was 67.2%, while that of the 16.8% Ageratina pichinchensis extract was 79.1%. Regarding clinical evolution, analysis of results at the end of treatment evidenced that the 16.8% concentration possesses higher therapeutic effectiveness with a significant statistical difference (p=0.010). No treatment produced side effects.

CONCLUSION

Both concentrations of phytopharmaceuticals possess high rates of effectiveness on patients with mild and moderate onychomycosis, and the formulation with a 16.8% concentration possesses higher effectiveness.