Study to Evaluate the Efficacy and Safety of P-3058 10% Nail Solution in the Treatment of Toenail Onychomycosis

A Multicenter, Randomized, Double-blind, Parallel, Vehicle-controlled Study to Evaluate the Efficacy and Safety of P-3058 10% Nail Solution in the Treatment of Onychomycosis

The purpose of this study is to determine whether P-3058 nail solution is a safe and effective treatment for onychomycosis.

Inclusion Criteria:

• Written informed consent
• Patients aged 12 years and older of any race.
• Males or females.
• Patients with onychomycosis involving ≥ 20% to ≤ 50% of target big toenail.
• Patients with a positive KOH examination and culture positive for dermatophyte

Exclusion Criteria:

• Presence of "yellow spikes" on the target nail.
• Presence of dermatophytoma on the target nail.
• Presence of nail thickness exceeding 2 mm.
• Patients with proximal subungual involvement
• Patients with severe plantar or moccasin tinea pedis
• Patients with nail abnormalities due to other conditions
• Patients with life expectancy less than 2 years.
• Chemotherapy, immunosuppressive therapy in the 12 weeks prior to Screening visit (V1).
• Systemic corticosteroids, antimetabolites and immune-stimulants therapy in the 4 weeks prior to Screening visit (V1).
• HIV infection or any other immunodeficiency.
• Alcohol or substance abuse.
• Patients with history of allergic reactions to terbinafine or its excipients.
• Woman who is pregnant, nursing an infant, or planning a pregnancy during the study period.