Safety and Efficacy Study of Subjects With Onychomycosis of the Great Toenail
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.
|Study Design:||Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
|Official Title:||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|
- Clinical evidence of complete clearance of the treatment-targeted great toenail plus a negative fungal culture at Day 360 [ Time Frame: Day 360 ] [ Designated as safety issue: No ]
- Clear nail growth of the targeted toenail [ Time Frame: Days 360 ] [ Designated as safety issue: No ]
- Mycological evaluations (negative KOH and negative fungal culture) compared to baseline [ Time Frame: Day 90, 180, 270 and 360 ] [ Designated as safety issue: No ]
- Length of time to clinical evaluation of clear or at least 5 mm of CNG [ Time Frame: Baseline, Days, 14, 30, 60, 90, 120, 150, 180, 210, 240, 270, 300 and 360 ] [ Designated as safety issue: No ]
|Study Start Date:||March 2007|
|Study Completion Date:||July 2008|
|Primary Completion Date:||July 2008 (Final data collection date for primary outcome measure)|
Experimental: Group 1
AN2690 Solution, 5.0%
Drug: AN2690 Solution, 5.0%
Once daily application for 360 days
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.
|Instituto Dermatologico Jalisciense|
|Mexico City, Mexico|
|Study Director:||Karl Beutner, MD, PhD||Anacor Pharmaceuticals, Inc.|