Phase 3
N=518
Efficacy, Safety, and Tolerability of Topical Terbinafine in Patients With Mild to Moderate Toenail Fungus of the Big Toenail
Onychomycosis
Bottom Line
View on ClinicalTrials.gov: NCT00443898 ↗Enrolled (actual)
518
Serious AEs
3.9%
Results posted
Apr 2011
Primary outcome: Primary: Efficacy Assessed by Complete Cure Rate at the End of Study (Week 52) After Treating for 24 or 48 Weeks. — 0.79; 0.78; 1.47; 0.00 Percentage of Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- terbinafine (Drug); Placebo (Drug)
- Age
- Pediatric, Adult, Older Adult · 12+ yrs
- Sex
- All
- Sponsor
- Novartis Pharmaceuticals
- Primary completion
- Jun 2008
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy Assessed by Complete Cure Rate at the End of Study (Week 52) After Treating for 24 or 48 Weeks. |
0.79; 0.78; 1.47; 0.00 | — |
| SECONDARY Efficacy Assessed by Mycological Cure (Negative Culture and Negative KOH Microscopy) at the End of Study After Treating Patients for 24 or 48 Weeks. |
10.32; 6.25; 15.44; 3.13 | — |
| SECONDARY Efficacy Assessed by Clinical Efficacy at the End of Study After Treating Patients for 24 or 48 Weeks. |
1.59; 2.34; 3.68; 1.56 | — |
| SECONDARY Number of Participants Assessed With Adverse Events and Serious Adverse Events |
126; 124; 135; 128 | — |
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 with mild to moderate toenail fungus disease of the big toenail and their responses to two treatment durations, 24 or 48 weeks.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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
Data sourced from ClinicalTrials.gov (NCT00443898). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.