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

Polichem S.A.

Status and phase: Completed; Phase 3

Conditions: Onychomycosis

Treatments: Drug: amorolfine 5%; Drug: P-3058 10%; Drug: vehicle of P-3058 10%

Study type: Interventional

Funder types: Industry

Identifiers

NCT02549001

2015-000561-31 (EudraCT Number)

PM1331

Details and patient eligibility

About

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

Enrollment: 953 patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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953 participants in 3 patient groups, including a placebo group

P-3058 10%

Experimental group

Description:

P-3058 10%

Treatment:

Drug: P-3058 10%

vehicle of P-3058 10%

Placebo Comparator group

Description:

vehicle of P-3058 10%

Treatment:

Drug: vehicle of P-3058 10%

amorolfine 5%

Active Comparator group

Description:

Loceryl®

Treatment:

Drug: amorolfine 5%