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

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

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

Study Overview

• Status: Completed
• Conditions: Onychomycosis
• Intervention / Treatment: Drug: NVXT topical; Drug: Placebo (Vehicle) Topical

Detailed Description

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
• Enrollment (Actual): 184
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15219
      • Novum Pharmaceutical Research Services (Novum)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: NVXT topical; 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; topical treatment; Other Names: Active
Placebo Comparator: Placebo (Vehicle) Topical; two 8-week treatment periods separated by a 32-week rest period (Treatment Group C),	Drug: Placebo (Vehicle) Topical; Placebo (Vehicle) Topical; Other Names: placebo

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Taro Pharmaceuticals USA

Study record dates

Study Major Dates

• Study Start (Actual): March 21, 2016
• Primary Completion (Actual): March 6, 2018
• Study Completion (Actual): June 21, 2018

Study Registration Dates

• First Submitted: October 12, 2016
• First Submitted That Met QC Criteria: October 12, 2016
• First Posted (Estimate): October 14, 2016

Study Record Updates

• Last Update Posted (Actual): December 20, 2018
• Last Update Submitted That Met QC Criteria: December 18, 2018
• Last Verified: December 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Mycoses; Tinea; Dermatomycoses; Nail Diseases; Onychomycosis
• Other Study ID Numbers: NVXT 1404

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No