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

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

Official Title
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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

Conditions
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Onychomycosis

Intervention / Treatment
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* Drug: P-3058 10%
* Drug: vehicle of P-3058 10%
* Drug: amorolfine 5%


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: P-3058 10%<br>P-3058 10% | Drug: P-3058 10%<br> <br> |
| Placebo Comparator: vehicle of P-3058 10%<br>vehicle of P-3058 10% | Drug: vehicle of P-3058 10%<br> <br> |
| Active Comparator: amorolfine 5%<br>Loceryl® | Drug: amorolfine 5%<br> <br> * Other names: Loceryl®;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Complete cure of target great toenail defined as negative KOH microscopy, negative culture for dermatophytes and target nail totally clear. |  | Week 60 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Responder rate of the target toenail, defined as negative KOH microscopy, negative culture for dermatophytes and ≤10% residual involvement of the target toenail. |  | Week 60 | 
| Negative culture rate for dermatophytes of the target nail. |  | Week 60 | 
| Mycological cure defined as negative KOH microscopy and negative culture for dermatophytes of the target nail. |  | Week 60 | 
| Overall safety by recording any AE during the entire study duration and the local tolerability by means of severity scores for skin irritation. |  | Week 60 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Onychomycosis, Nail fungus