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Efficacy of Topical Antifungal Nail Solution Versus Topical Placebo Solution for the Treatment of Pedal Onychomycosis: A Randomized Controlled Trial

Summary

This study tested whether a new antifungal solution called Tolcylen® could effectively treat toenail fungus compared to a placebo. Over 9 months, participants using the active treatment showed dramatic improvements, with over half achieving complete fungal elimination and 70% showing significant nail healing. Beyond just getting rid of the fungus, patients reported much better quality of life with less discomfort and improved appearance as early as 3 months into treatment.

Background

Pedal onychomycosis is a common fungal infection affecting 2-3% of the general population and up to 25-30% of elderly individuals. Current treatment options include debridement combined with topical and/or oral antifungal medications. Tolcylen® is a topical solution containing tolnaftate suspended in a low surface tension delivery vehicle designed to penetrate nail keratin.

Objective

To compare the efficacy of an active topical antifungal nail solution (Tolcylen®) versus placebo for treating pedal onychomycosis through a randomized controlled trial. Primary outcomes measured mycological cure, while secondary outcomes assessed visible nail involvement and toenail-related quality of life.

Results

The active solution group achieved significantly higher mycological cure (54.84% vs 2.63%, p<0.0001) and clinical cure (70% vs 5.56%, p<0.0001) compared to placebo. Forty-seven percent of treated participants showed complete nail clearance. Significant improvements in quality of life measures appeared as early as 3 months and continued through 9 months.

Conclusion

Topical Tolcylen® solution demonstrated statistically significant superiority over placebo in achieving mycological and clinical cure of pedal onychomycosis. The treatment also improved toenail-related quality of life including reduced symptoms, better appearance, and increased treatment satisfaction compared to placebo.
  • Published in:Infectious Diseases and Therapy,
  • Study Type:Randomized Controlled Trial,
  • Source: PMID: 40413715, DOI: 10.1007/s40121-025-01165-8
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