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

Phase 2

Completed

• Conditions: Onychomycosis
• Interventions: Drug: Placebo (Vehicle) Topical; Drug: NVXT topical

• Registration Number: NCT02933879
• Lead Sponsor: Taro Pharmaceuticals USA

Brief Summary

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

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 Timeline

• Study Start: 2016-03-21
• Study First Submitted: 2016-10-12
• Study First Submitted QC: 2016-10-12
• Study First Posted: 2016-10-14
• Primary Completion: 2018-03-06
• Study Completion: 2018-06-21
• Results First Submitted: 2018-11-12
• Status Verified: 2018-12
• Results First Submitted QC: 2018-12-18
• Last Update Submitted: 2018-12-18
• Results First Posted: 2018-12-20
• Last Update Posted: 2018-12-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 184

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo (Vehicle) Topical	Placebo (Vehicle) Topical	two 8-week treatment periods separated by a 32-week rest period (Treatment Group C),
NVXT topical	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),

Primary Outcome Measures

Name	Time	Method
Number of Patients in Each Treatment Group With a Complete Therapeutic Cure	Day 141	Complete therapeutic cure is defined as both complete clinical and mycological cure of the target toenail

Secondary Outcome Measures

Name	Time	Method
Number of Patients in Each Treatment Group With a Complete or Almost Complete Therapeutic Cure	Day 141	Almost complete therapeutic cure is defined as both mycological and satisfactory clinical cure of the target toenail
Number of Patients in Each Treatment Group With a Complete Clinical Cure	Day 141	Complete clinical cure is defined as 0% nail involvement.
Number of Patients in Each Treatment Group With a Mycological Cure	Day 141	Mycological cure is defined as a negative KOH test and a negative fungal culture.
Number of Patients in Each Treatment Group With a Satisfactory Clinical Cure	Day 141	Satisfactory clinical cure is defined as \<5% of the target toenail involvement.

Trial Locations

Locations (1)

Novum Pharmaceutical Research Services (Novum); 🇺🇸 Pittsburgh, Pennsylvania, United States