NCT01278394

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: 29 (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% AN2690 Solution in the treatment of distal, subungual onychomycosis of the great target toenail.

Detailed description

In this cohort, only the targeted great toenail identified at Baseline prior to the commencement of treatment from culture results collected at the Screening visit were evaluated for primary efficacy whereas all treated toenails were evaluated for safety. At each visit, the investigator was asked to make a clinical evaluation of the targeted great nail, marking whether or not they considered the nail to be clear of onychomycosis. This evaluation was the basis for determining whether or not study medication should be dispensed at the visit. This record includes information only for Cohort 3 (5% solution) of the study. Cohorts 1 and 2, are described in NCT00679523 (7.5% solution). No comparison was made between Cohorts 1\&2 and Cohort 3.

Conditions

• Onychomycosis

Interventions

Type	Name	Description
DRUG	AN2690 Solution, 5.0%	Once daily application for 360 days

Timeline

• Start date: 2007-03-01
• Primary completion: 2008-07-01
• Completion: 2008-07-01
• First posted: 2011-01-17
• Last updated: 2018-12-06
• Results posted: 2014-08-15

Locations

2 sites across 1 country: Mexico