Clinical Trial: Safety and Efficacy of NVXT Solution in Mild-to-Moderate Fungal Infection of the Toe Nail

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: A Randomized, Double-Blind, Placebo-Controlled, Pilot Study to Assess the Safety and Efficacy of NVXT Solution in Patients With Mild-to-Moderate Fungal Infection of the Toe Nail

Brief Summary: This study will examine the safety, tolerability and efficacy of NVXT in a new formulation in patients with mild-to-moderate fungal infection of the toe nail.

Detailed Summary: This Phase IIa pilot multiple-dose study will examine the safety, tolerability and efficacy of NVXT in a new formulation in patients with mild-to-moderate fungal infection of the toe nail.
Sponsor: Taro Pharmaceuticals USA

Current Primary Outcome: negative fungal culture [ Time Frame: 28 days ]

To assess negative fungal culture after repeated once-daily topical applications for 28 days


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • negative fungal culture [ Time Frame: 60 days ]
    To assess negative fungal culture after repeated once-daily topical applications for 60 days
  • negative fungal culture [ Time Frame: 90 days ]
    To assess negative fungal culture at 30 days after end of 60 day treatment
  • negative fungal culture [ Time Frame: 180 days ]
    To assess negative fungal culture at 120 days after end of 60 day treatment
  • negative fungal culture [ Time Frame: 270 days ]
    To assess negative fungal culture at 210 days after end of 60 day treatment
  • negative fungal culture [ Time Frame: 360 days ]
    To assess negative fungal culture at 300 days after end of 60 day treatment
  • Mycological cure (negative KOH test AND a negative fungal culture) [ Time Frame: 90 days ]
    To assess mycological cure (negative KOH test AND a negative fungal culture) at visit conducted 30 days after end of 60 day treatment
  • Mycological cure (negative KOH test AND a negative fungal culture) [ Time Frame: 180 days ]
    To assess mycological cure (negative KOH test AND a negative fungal culture) at visit conducted 120 days after end of 60 day treatment
  • Mycological cure (negative KOH test AND a negative fungal culture) [ Time Frame: 270 days ]
    To assess mycological cure (negative KOH test AND a negative fungal culture) at visit conducted 210 days after end of 60 day treatment
  • Mycological cure [ Time Frame: 360 days ]
    To assess mycological cure (negative KOH test AND a negative fungal culture) at visit conducted 300 days after end of 60 day treatment
  • Complete cure (negative KOH test AND a negative fungal culture, and 0% nail involvement by visual assessment) [ Time Frame: 90 days ]
    To assess the complete cure (negative KOH test AND a negative fungal culture, and 0% nail involvement by visual assessment) at visit conducted 30 days after the end of 60 day treatment
  • Complete cure (negative KOH test AND a negative fungal culture, and 0% nail involvement by visual assessment) [ Time Frame: 180 days ]
    To assess the complete cure (negative KOH test AND a negative fungal culture and 0% nail involvement by visual assessment) at visit conducted 120 days after the end of 60 day treatment
  • Complete cure (negative KOH test AND a negative fungal culture, and 0% nail involvement by visual assessment) [ Time Frame: 270 days ]
    To assess the complete cure (negative KOH test AND a negative fungal culture and 0% nail involvement by visual assessment) at visit conducted 210 days after the end of 60 day treatment
  • Complete cure (negative KOH test AND a negative fungal culture, and 0% nail involvement by visual assessment) [ Time Frame: 360 days ]
    To assess the complete cure (negative KOH test AND a negative fungal culture and 0% nail involvement by visual assessment) at visit conducted 300 days after the end of 60 day treatment
  • Therapeutic success (negative KOH test AND a negative fungal culture, ≤5% nail involvement or 50% improvement in nail involvement by visual assessment) [ Time Frame: 90 days ]
    To assess the therapeutic success (negative KOH test AND a negative fungal culture, ≤5% nail involvement or 50% improvement in nail involvement by visual assessment) at visit conducted 30 days after end of 60 day treatment
  • Therapeutic success (negative KOH test AND a negative fungal culture, ≤5% nail involvement or 50% improvement in nail involvement by visual assessment) [ Time Frame: 180 days ]
    To assess the therapeutic success (negative KOH test AND a negative fungal culture, ≤5% nail involvement or 50% improvement in nail involvement by visual assessment) at visit conducted 120 days after end of 60 day treatment
  • Therapeutic success (negative KOH test AND a negative fungal culture, ≤5% nail involvement or 50% improvement in nail involvement by visual assessment) [ Time Frame: 270 days ]
    To assess the therapeutic success (negative KOH test AND a negative fungal culture, ≤5% nail involvement or 50% improvement in nail involvement by visual assessment) at visit conducted 210 days after end of 60 day treatment
  • Therapeutic success (negative KOH test AND a negative fungal culture, ≤5% nail involvement or 50% improvement in nail involvement by visual assessment) [ Time Frame: 360 days ]
    To a

    Original Secondary Outcome: Same as current

    Information By: Taro Pharmaceuticals USA

    Dates:
    Date Received: December 27, 2014
    Date Started: December 2014
    Date Completion:
    Last Updated: May 3, 2017
    Last Verified: May 2017