Treatment of Mild to Moderate Distal Subungual Onychomycosis of the Toenail

Study Overview
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Brief Summary
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The purpose of the study is to determine whether NB002, 0.25%, and 0.5% are safe and effective in the treatment of distal subungual onychomycosis of the toenail.

Detailed Description
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The purpose of the study is to determine whether NB002, 0.25%, and 0.5% are safe and effective in the treatment of distal subungual onychomycosis of the toenail.

Official Title
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A Randomized, Double-Blind, Parallel-Group,Multicenter, Dose-Response, Vehicle-Controlled Study of the Safety and Efficacy of NB-002 in the Treatment of Mild to Moderate Distal Subungual Onychomycosis of the Toenail

Conditions
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Onychomycosis

Intervention / Treatment
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* Drug: NB-002
* Drug: Vehicle control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: are healthy males or females between the ages of 18 and 75 years of age; have a clinical diagnosis of mild to moderate DSO in the nail of at least one great toe, involving 25%-67% of the nail, without lunular or proximal involvement; positive mycology results (ie, KOH test and culture of a dermatophyte) from the target great toenail; refrain from using any lotions, creams, liquids, or polish on treated toenails or on the skin immediately adjacent to the toenails during the treatment period unless directed to do so by the investigator; are willing to refrain from using topical steroids or topical antifungals on toenails or the skin immediately adjacent to the toenails; or systemic antifungals for the duration of the study; Exclusion Criteria: females who are pregnant, plan to become pregnant during the study, or are nursing a child; are hypersensitive to topical creams, ointments, medications, or surfactants; have received systemic antifungal therapy for any reason within 3 months, or topical antifungal therapy on the toenails or skin immediately adjacent to the toenails within 3 weeks prior to the start of the study; or have taken any investigational drug within 4 weeks prior to the start of the study. Other protocol-defined inclusion/exclusion criteria may apply.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NB-002 0.25% BID<br> | Drug: NB-002<br> <br> |
| Experimental: NB-002 0.5% QD<br> | Drug: NB-002<br> <br> |
| Experimental: NB-002 0.5% BID<br> | Drug: NB-002<br> <br> |
| Sham Comparator: Vehicle control<br> | Drug: Vehicle control<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Planimetry assessment of the target great toenail |  | Week 24 | 
| Rate of complete cure |  | Week 46 | 
| Rate of therapeutic success |  | Week 46 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator's visual assessment of length of new unaffected nail |  |  | 
| The presence/absence of DSO on all toenails |  |  | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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chronic persistent infection of the nail bed or plate