NCT00679770

Study of Different Doses of a Novel Treatment for Onychomycosis

A Randomized, Double-blind, Vehicle-controlled, Multi-center Study To Evaluate The Safety And Efficacy Of Topically Applied An2690 2.5%, 5.0%, And 7.5% Solutions Vs. Vehicle For The Treatment Of Adult Subjects With Onychomycosis Of The Great Toenail.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 28 (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 2.5%, 5.0%, and 7.5% AN2690 Solutions compared to the vehicle alone in the treatment of distal, subungual onychomycosis of the great target toenail.

Detailed description

The intent is for all subjects to complete a 180 day treatment period consisting of 90 consecutive days of once daily treatment with their assigned study treatment followed by an additional 90 days of three times weekly dosing, even if the treated toenail(s) is evaluated as a "complete responder" prior to the end of treatment 180 day treatment period. At the end of the 180-Day treatment period, subjects who remain in the study will be classified as complete responders, partial responders, or non-responders. All complete or partial responders will continue to be followed for an additional 180 days until the last evaluation for inclusion in the final analysis. Periodic efficacy and local tolerance evaluations of the test medication will be performed of the target great toenail and all other treated toenails. KOH wet mounts and fungal cultures from the treatment-targeted great toenail will be performed on the same schedule. Subjects will also be queried for adverse events and evaluated for application site reactions. Clinical laboratory assessment for safety will be made at Screening, periodically throughout the study, and upon premature discontinuation from the study.

Conditions

• Distal, Subungual Onychomycosis

Interventions

Type	Name	Description
DRUG	AN2690, 2.5%	Once daily application for 90 days and 3 x weekly for 90 days
DRUG	AN2690, 5%	Once daily application for 90 days and 3 x weekly for 90 days
DRUG	AN2690, 7.5%	Once daily application for 90 days and 3 x weekly for 90 days
DRUG	Vehicle	Once daily application for 90 days and 3x weekly for 90 days

Timeline

• Start date: 2006-06-30
• Primary completion: 2007-08-31
• Completion: 2007-08-31
• First posted: 2008-05-19
• Last updated: 2018-02-20

Locations

4 sites across 1 country: United States