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 ]
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