New formulation for topical treatment of onychomycoses.

BACKGROUND: In order to treat onychomycosis, topical and systemic medications are available. The choice of a systemic or topic treatment depends on numerous factors, such as patient's age, the presence of comorbidity, responsible fungal species, the clinical form of onychomycosis, its location (fingernails or toenails), the number of nails affected and the percentage of the nail plate infected. As for topical medications, given that nail plate has an insufficiently permeable structure, it is necessary to use appropriate formulae that create in the surface of the nail plate a film able, in turn, to function both as an active ingredient's deposit and moisturising agent in nail's superficial layers in order to facilitate the spread of the active ingredient. In this manuscript, we wanted to evaluate the effectiveness and tolerability rate of a new topical formulation (Miconal Nails®, Morgan srl, Vicenza, Italy) composed of hydrogenated castor oil, hydroxyethyl cellulose, and other ingredients (urea, climbazole, piroctone olamine, undecylenic acid).

METHODS: We selected 25 patients of both sexes whose median age was between 20 and 70 years, and were affected by onychomycosis in a single toe. Their onychomycosis was a distolateral subungual type (with a <50% invasion of nail plate and sparing of lunula) and white superficial. The treatment was evaluated with the following possible outcomes: complete healing, improvement, stationarity, worsening.

RESULTS: Patients were 11 female subjects and 14 male subjects, whose median age was 45. A complete healing was achieved in 15 patients. In 3 cases the clinical presentation appeared unchanged with a persistence of mycological evidence. The response to the treatment was assessed as improvement in 7 patients.

CONCLUSIONS: In our experience, this new product is an effective weapon that enhances the therapeutic selection of topical formulae for treating onychomycosis. If used alone in the cases that meet inclusion criteria for topical treatment, it allowed us to achieve a complete healing just with a 5-month treatment in 60% of cases, data that reached 76% on the follow-up visit.