Distal, Subungual Onychomycosis Clinical Trial
Official title:
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
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.
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.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT00679770 -
Study of Different Doses of a Novel Treatment for Onychomycosis
|
Phase 2 |