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

Study Status: Active, not recruiting
Recruit Status: Active, not recruiting
Study Type: Interventional

Official Title: 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

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 Summary: 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.
Sponsor: Taro Pharmaceuticals USA

Current Primary Outcome: proportion of patients in each treatment group with a complete therapeutic cure [ Time Frame: day 365 ]

Complete therapeutic cure is defined as both complete clinical and mycological cure of the target toenail


Original Primary Outcome: propmiion of patients in each treatment group with a complete therapeutic cure [ Time Frame: day 365 ]

Complete therapeutic cure is defined as both complete clinical and mycological cure of the target toenail


Current Secondary Outcome:

  • proportion of patients in each treatment group with a complete or almost complete therapeutic cure [ Time Frame: day 365 ]
    Almost complete therapeutic cure is defined as both mycological and satisfactory clinical cure of the target toenail
  • proportion of patients in each treatment group with a mycological cure [ Time Frame: day 365 ]
    Mycological cure is defined as a negative KOH test and a negative fungal culture.
  • proportion of patients in each treatment group with a complete clinical cure [ Time Frame: day 365 ]
    Complete clinical cure is defined as 0% nail involvement.
  • proportion of patients in each treatment group with a satisfactory clinical cure [ Time Frame: day 365 ]
    Satisfactory clinical cure is defined as <5% of the target toenail involvement.


Original Secondary Outcome: Same as current

Information By: Taro Pharmaceuticals USA

Dates:
Date Received: October 12, 2016
Date Started: March 21, 2016
Date Completion: June 30, 2018
Last Updated: May 3, 2017
Last Verified: May 2017