The purpose of this study is to determine whether AN2690 topical solution is a safe and effective treatment for onychomycosis of the toenail.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
604
AN2690 Topical Solution, 5%, applied once daily for 48 weeks
AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks
Complete Cure (Completely Clear Nail and Negative Mycology) of Target Great Toenail at Week 52
No clinical evidence of onychomycosis as evidenced by normal toenail plate, no onycholysis, and no subungual hyperkeratosis, and negative KOH wet mount and negative fungal culture.
Time frame: Week 52
Completely Clear or Almost Clear Target Great Toenail at Week 52
No clinical evidence of onychomycosis as evidenced by normal toenail plate, no onycholysis, and no subungual hyperkeratosis, or no more than minimal evidence of onychomycosis as evidenced by toenail plate dystrophic or discolored over ≤ 10% of the distal aspect, with minimally evident onycholysis and subungual hyperkeratosis.
Time frame: Week 52
Treatment Success (Completely Clear or Almost Clear Nail and Negative Mycology) of Target Great Toenail at Week 52
No clinical evidence of onychomycosis as evidenced by normal toenail plate, no onycholysis, and no subungual hyperkeratosis, or no more than minimal evidence of onychomycosis as evidenced by toenail plate dystrophic or discolored over ≤ 10% of the distal aspect, with minimally evident onycholysis and subungual hyperkeratosis, and negative KOH wet mount and negative fungal culture.
Time frame: Week 52
Negative Mycology of Target Great Toenail at Week 52
Negative KOH and negative fungal culture.
Time frame: Week 52
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Investigational Site
Phoenix, Arizona, United States
Investigational Site
Novato, California, United States
Investigational Site
Oceanside, California, United States
Investigational Site
San Diego, California, United States
Investigational Site
San Francisco, California, United States
Investigational Site
Santa Rosa, California, United States
Investigational Site
Miami, Florida, United States
Investigational Site
Miami, Florida, United States
Investigational Site
Nampa, Idaho, United States
Investigational Site
Evansville, Indiana, United States
...and 22 more locations