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