Clinical Trial on Onychomycosis With P-3058 Nail Solution in Pediatric Population

Multicentre, Open Label Study to Assess the Tolerability of P-3058 Nail Solution in Paediatric Patients Affected by Mild-to-moderate Onychomycosis

Pediatric patients affected by mild-to-moderate distal subungual onychomycosis (DSO) or affected by white superficial onychomycosis (WSO), due to dermatophytes, will be treated topically with P-3058 nail solution according to the appropriate treatment schedule.

Inclusion Criteria:

• Age between 2 to 17 years
• Males and females
• Clinical diagnosis of mild-to-moderate distal sub-ungual onychomycosis without spikes/dermatophytoma and without lunula involvement or white superficial onychomycosis.
• Positive mycroscopy examination from the target nail at screening.
• Positive culture for dermatophyte from the target nail at screening.

Exclusion Criteria:

• Patients with onychomycosis caused by yeasts or non-dermatophytes mould.
• Patients with nail psoriasis.
• Patients with nail changes due to eczema, lichen planus or alopecia areata.
• Patients with one-hand two-foot syndrome.
• Patients with immunodeficiency disorder or use of immune suppressive therapy 3 months prior to screening visit or need for it.
• Use of systemic antifungal drugs in the 6 months prior to screening visit.
• Use of topical nail antifungal drugs in the four weeks prior to screening visit.