NCT02933879

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 184 (actual)
• Sponsor: Sun Pharmaceutical Industries, Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• Onychomycosis

Interventions

Type	Name	Description
DRUG	NVXT topical	topical treatment
DRUG	Placebo (Vehicle) Topical	Placebo (Vehicle) Topical

Timeline

• Start date: 2016-03-21
• Primary completion: 2018-03-06
• Completion: 2018-06-21
• First posted: 2016-10-14
• Last updated: 2018-12-20
• Results posted: 2018-12-20

Locations

1 site across 1 country: United States