NCT00679523

Safety and Efficacy Study of Subjects With Onychomycosis of the Great Toenail

An Open-Label, Rising Multiple-Dose, Multi-Center Study to Evaluate the Safety and Efficacy of Topically Applied AN2690 5.0% and 7.5% Solution for the Treatment of Adult Subjects With Onychomycosis of the Great Toenail

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Pfizer · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to determine the safety and efficacy of 5.0% and 7.5% AN2690 Solution in the treatment of distal, subungual onychomycosis of the great target toenail.

Detailed description

The first group of 30 protocol-qualified subjects will be assigned to Treatment Group 1 and given 5% AN2690 Solution. Provided that there is adequate evidence of clinical safety after two weeks of dosing with 5% AN2690 Solution, a second group of 30 protocol-qualified subjects will be assigned to Treatment Group 2 and given 7.5% AN2690 Solution. A third group of 30 subjects will be enrolled and assigned the highest safe concentration of AN2690 evaluated in this study.

Conditions

• Onychomycosis

Interventions

Type	Name	Description
DRUG	AN2690 Solution, 5.0%	Once daily application for 180 days
DRUG	AN2690 Solution, 7.5%	Once daily application for 180 days

Timeline

• Start date: 2005-11-01
• Primary completion: 2007-02-01
• Completion: 2007-02-01
• First posted: 2008-05-19
• Last updated: 2018-11-14

Locations

9 sites across 1 country: Mexico