BACKGROUND

The growing prevalence of mycoses worldwide, particularly onychomycoses, resistant to antifungal agents is alarming. The way to overcome the resistance problem and increase the effectiveness of onychomycosis topical therapy is the use of broad-spectrum antifungal agents with low or no resistance or antifungal agent combinations.

OBJECTIVE

To evaluate clinical and mycological efficacy and safety of the nail polish containing ciclopirox 8% + lactic acid with a water-soluble base (hydrolacquer) with a film-forming agent as a monotherapy in patients with distal onychomycosis of hands and feet involving not more than ¹/₃ area of the nail plate.

MATERIAL AND METHODS

An open multi-center study including 8 centers in different regions of the Russian Federation was conducted. The study included 111 patients aged 18 to 85 years with onychomycosis of feet/hands. Prior to the study, the diagnosis was confirmed with a wet mount potassium hydroxide (KOH) prep test. At each visit, clinical efficacy was assessed, including changes in nail plate color, lesion area, nail plate shape change, Scoring Clinical Index for Onychomycosis (SCIO), adverse events were recorded, data on concomitant therapy were updated, and nail plates were photographed.

RESULTS

The proportion of patients with mycological recovery was 95.5% (106 patients) according to the study results. Of these, 58 (52.3%) patients completed therapy at week 16 and 21 (18.9%) patients completed therapy at week 48.The mean SCIO score decreased from 4.6 at the start of therapy to 1.6 at week 48, a decrease of 66.3%.

CONCLUSION

The obtained results indicate clinical and mycological efficacy of the studied nail polish in distal onychomycoses of hands and feet involving not more than ¹/₃ area of the nail plate.