Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Multi-Site Phase 2b Clinical Study

Study Overview
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Brief Summary
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A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Multi- Site Phase 2b Clinical Study to Assess the Efficacy, Safety and Tolerability of 8-Week Regimens of NVXT topical product in Patients with Mild to Moderate Onychomycosis

Detailed Description
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Evaluate safety and tolerability of the two regimens of NVXT (Treatment Groups A and B) in patients with mild to moderate distal subungual onychomycosis of the target toenail.

Official Title
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A Randomized, Placebo-Controlled, Double-Blind, Parallel-Group, Multi- Site Phase 2b Clinical Study to Assess the Efficacy, Safety and Tolerability Patients With Mild to Moderate Onychomycosis

Conditions
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Onychomycosis

Intervention / Treatment
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* Drug: NVXT topical
* Drug: Placebo (Vehicle) Topical


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of onychomycosis of the target toenail (defined as one of the infected great toenails). Exclusion Criteria: Females who are pregnant, lactating or likely to become pregnant during the study.

Ages Eligible for Study
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Minimum Age: 18 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: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: NVXT topical<br>daily dosing for one 8-week treatment period (Treatment Group A) and two 8-week treatment periods separated by a 32-week rest period (Treatment Group B), | Drug: NVXT topical<br>* topical treatment<br>* Other names: Active;|
| Placebo Comparator: Placebo (Vehicle) Topical<br>two 8-week treatment periods separated by a 32-week rest period (Treatment Group C), | Drug: Placebo (Vehicle) Topical<br>* Placebo (Vehicle) Topical<br>* Other names: placebo;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients in Each Treatment Group With a Complete Therapeutic Cure | Complete therapeutic cure is defined as both complete clinical and mycological cure of the target toenail | Day 365 | 
| Number of Patients in Each Treatment Group With a Complete Therapeutic Cure | Complete therapeutic cure is defined as both complete clinical and mycological cure of the target toenail | Day 141 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients in Each Treatment Group With a Complete or Almost Complete Therapeutic Cure | Almost complete therapeutic cure is defined as both mycological and satisfactory clinical cure of the target toenail | Day 365 | 
| Number of Patients in Each Treatment Group With a Complete or Almost Complete Therapeutic Cure | Almost complete therapeutic cure is defined as both mycological and satisfactory clinical cure of the target toenail | Day 141 | 
| Number of Patients in Each Treatment Group With a Mycological Cure | Mycological cure is defined as a negative KOH test and a negative fungal culture. | day 365 | 
| Number of Patients in Each Treatment Group With a Mycological Cure | Mycological cure is defined as a negative KOH test and a negative fungal culture. | Day 141 | 
| Number of Patients in Each Treatment Group With a Complete Clinical Cure | Complete clinical cure is defined as 0% nail involvement. | day 365 | 
| Number of Patients in Each Treatment Group With a Complete Clinical Cure | Complete clinical cure is defined as 0% nail involvement. | Day 281 | 
| Number of Patients in Each Treatment Group With a Complete Clinical Cure | Complete clinical cure is defined as 0% nail involvement. | Day 141 | 
| Number of Patients in Each Treatment Group With a Satisfactory Clinical Cure | Satisfactory clinical cure is defined as <5% of the target toenail involvement. | day 365 | 
| Number of Patients in Each Treatment Group With a Satisfactory Clinical Cure | Satisfactory clinical cure is defined as <5% of the target toenail involvement. | Day 281 | 
| Number of Patients in Each Treatment Group With a Satisfactory Clinical Cure | Satisfactory clinical cure is defined as <5% of the target toenail involvement. | Day 141 |