Clinical Evaluation of a Topical Formulation for the Management of Onychomycosis

BACKGROUND: Onychomycosis is a diffused fungal-associated disease affecting the nails. It induces discoloration, dystrophy, and, in the most severe cases, nail detachment. No completely effective pharmacological cures are available for onychomycosis. Available treatment options usually require a long-term treatment period and might raise safety concerns. OBJECTIVE: The aim of this preliminary clinical study is to evaluate the efficacy of Myco Clear® (MC) in improving the structural integrity and appearance of nails affected by mild onychomycosis. MC is a topical product to be applied on the nails either for onychomycosis treatment or for the prevention of fungal nail infections. Its main action is the formation of a mechanic protective barrier on the nail surface, which protects the damaged nail structure from additional external aggressions and prevents further pathogen penetration. METHODS: This monocentric, single-arm investigation enrolled 30 subjects with damaged nails on the feet. Patients were asked to apply the product once a day for 56 consecutive days; the instrumental analysis of nail roughness was obtained after seven, 14, 28, and 56 days of product application. In addition, the clinical evaluation of nail integrity and hardness were performed at baseline and after seven, 14, 28 and 56 days. RESULTS: The obtained data were statistically evaluated in comparison to baseline. MC treatment significantly promoted a restoration of the nail structure and an improvement in its appearance; furthermore, no adverse events were reported, thus demonstrating that MC is optimally tolerated. CONCLUSION: The results of this pilot study suggest that MC is effective in improving the overall appearance and structural integrity of damaged nails affected by possible mild onychomycosis.