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

Sun Pharmaceutical Industries, Inc.184 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

184

Conditions

Onychomycosis

Interventions

NVXT topicalDRUG

topical treatment

Placebo (Vehicle) TopicalDRUG

Placebo (Vehicle) Topical

Eligibility

Sex: ALLMin age: 18 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

Novum Pharmaceutical Research Services (Novum)

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

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

Time frame: 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

Time frame: Day 141

Secondary Outcomes

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

Time frame: 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

Time frame: 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.

Time frame: 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.

Time frame: Day 141

Number of Patients in Each Treatment Group With a Complete Clinical Cure

Complete clinical cure is defined as 0% nail involvement.

Data from ClinicalTrials.gov

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