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

• Status: Completed
• Trial end date: 2018-09-17
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Polichem S.A.
• Treatments: Amorolfine

Criteria

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.