NCT00385502

A Trial of the Safety and Efficacy of EcoNail™ in the Treatment of Fungus Infections of the Great Toenail

A Phase II Trial of the Safety, Local Tolerability, and Efficacy of EcoNail™ (Econazole 5%/SEPA® 18% Nail Lacquer) in Onychomycosis of the Great Toenail

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Abeona Therapeutics, Inc · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

Approximately 40 qualified subjects with mild-to-moderate great toenail fungus infection will be treated for 48 weeks with lacquer application to at least one affected great toenail. All subjects will receive treatment with EcoNail™ lacquer.

Detailed description

This study will use a multi-center, open-label study design in subjects with onychomycosis of at least one great toenail to assess the safety, local tolerability, and efficacy of chronic daily ungual application of EcoNail™. Forty (40) evaluable subjects will apply study drug daily to at least one affected great toenail for 48 weeks. The subjects must comply with all inclusion and exclusion criteria.

Conditions

• Onychomycosis

Interventions

Type	Name	Description
DRUG	EcoNail™ (econazole 5%/SEPA® 18% nail lacquer)	nail lacquer applied daily for 48 weeks

Timeline

• Start date: 2006-09-01
• Primary completion: 2008-06-01
• Completion: 2008-06-01
• First posted: 2006-10-09
• Last updated: 2020-09-03

Locations

3 sites across 1 country: United States