Status:
COMPLETED
Efficacy, Safety and Tolerability of Topical 10% Terbinafine Hydrogen Chloride Versus 5% Amorolfine Nail Lacquer in Patients With Mild to Moderate Toenail Onychomycosis
Lead Sponsor:
Novartis
Conditions:
Onychomycosis
Eligibility:
All Genders
12-75 years
Phase:
PHASE3
Brief Summary
This study will evaluate the efficacy, safety and tolerability of topical 10% terbinafine hydrogen chloride applied daily versus 5% amorolfine nail lacquer applied twice a week in patients with mild t...
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)
- The target toenail area must have at least 25% to no more than 75% disease involvement without spikes.
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 terbinafine 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
- Patients with the target toenail involving the matrix (lunula) or having less than 2mm clear (unaffected) nail plate length beyond the proximal fold.
- Presence of dermatophytoma (defined as thick masses of fungal hyphae and necrotic keratin between the nail plate and nail bed) on the target nail.
- 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 :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2009
Estimated Enrollment :
1029 Patients enrolled
Trial Details
Trial ID
NCT00459537
Start Date
March 1 2007
End Date
January 1 2009
Last Update
May 6 2011
Active Locations (10)
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1
Novartis Investigative Site
Various Cities, Finland
2
Novartis Investigative Site
Various Cities, France
3
Novartis Investigative Site
Various Cities, Germany
4
Novartis Investigative Site
Various Cities, Hungary