Status:
COMPLETED
Efficacy, Safety, and Tolerability of Topical Terbinafine in Patients With Mild to Moderate Toenail Fungus of the Big Toenail
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Onychomycosis
Eligibility:
All Genders
12-75 years
Phase:
PHASE3
Brief Summary
This study is designed to assess the efficacy, safety and tolerability of a topical formulation of terbinafine solution applied daily in patients with toenail fungus. This trial will study patients wi...
Eligibility Criteria
Inclusion
- Male and females 12 - 75 years of age
- Fungal toenail infection of one or both of the large (great) toenails
- The nail infection must be due to a dermatophyte, (mixed infections \[dermatophyte and non-dermatophyte\] are not allowed)
Exclusion
- Target foot must not have severe plantar (moccasin) tinea pedis that would require systemic therapy. Mild to moderate tinea pedis (athlete's foot) infection should be treated with terbinifine prior to baseline or at any time during the trial. Other topical treatments for athlete's foot may be recommended at the discretion of the investigator.
- Subjects must not have abnormalities of the nail that could prevent a normal appearing nail if clearing of infection is achieved
- No administration of systemic antifungal medications within 6 months prior to screening visit
- No application of prescription topical antifungal medications for toenail fungus within 3 months or other commercially available topical medications for toenail fungus applied directly to the toenails within 1 month prior to screening visit
- No professional pedicures or application of any nail polish product or nail cosmetic to the toenails after the screening visit
- Known pregnancy or lactation at time of enrollment
- Other protocol-defined inclusion/exclusion criteria may apply
Key Trial Info
Start Date :
December 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
518 Patients enrolled
Trial Details
Trial ID
NCT00443898
Start Date
December 1 2006
Last Update
May 3 2012
Active Locations (22)
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1
Dr. Boni Elewski
Birmingham, Alabama, United States, 35233
2
Dr. Stacy Smith
San Diego, California, United States, 92123
3
Dr. James Swinehart
Denver, Colorado, United States, 80210
4
Dr. David G. Armstrong
North Chicago, Illinois, United States, 60064