Efficacy, Safety, and Tolerability of Topical Terbinafine in Patients With Mild to Moderate Toenail Fungus of the Big Toenail
- Registration Number
- NCT00443898
- Lead Sponsor
- Novartis Pharmaceuticals
- 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 with mild to moderate toenail fungus disease of the big toenail and their responses to two treatment durations, 24 or 48 weeks.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 518
- 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)
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 terbinafine Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks 2 Placebo vehicle (placebo) applied once daily for 48 weeks 4 Placebo vehicle (placebo) applied once daily for 24 weeks 3 terbinafine Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks
- Primary Outcome Measures
Name Time Method Efficacy Assessed by Complete Cure Rate at the End of Study (Week 52) After Treating for 24 or 48 Weeks. 52 weeks Complete cure is defined as negative KOH microscopy and negative culture for dermatophytes.
and no residual involvement of the target toenail. The complete cure was a composite binary variable defined as "Yes" if:
* Mycological cure (negative KOH and negative culture for dermatophytes) and
* No residual involvement of the target toenail "No" if otherwise
- Secondary Outcome Measures
Name Time Method Efficacy Assessed by Mycological Cure (Negative Culture and Negative KOH Microscopy) at the End of Study After Treating Patients for 24 or 48 Weeks. 52 weeks Mycological cure is defined as negative KOH microscopy and negative culture for dermatophytes.
Mycological cure was a composite binary variable defined as "Yes"if :
* Negative microscopy and
* Negative culture for dermatophytes "No" if otherwise.Efficacy Assessed by Clinical Efficacy at the End of Study After Treating Patients for 24 or 48 Weeks. 52 weeks Clinical effectiveness is defined as negative KOH microscopy and negative culture for dermatophytes and \<= 10% residual involvement of the target toenail.
Clinical effectiveness was a composite binary variable defined as "Yes" if
* Mycological cure (negative KOH and negative culture for dermatophytes) and
* = 10% residual involvement of the target toenail "No" if otherwiseNumber of Participants Assessed With Adverse Events and Serious Adverse Events 52 weeks An adverse event (AE) is any adverse change in health or side effect that occurs while the participant is receiving the treatment or within a previously specified period of time after the treatment has been completed.
A Serious Adverse Event (SAE) is any untoward medical occurrence that results in death, is life-threatening requires, inpatient hospitalization or prolongation of existing hospitalization, results in persistent or significant disability/incapacity, is a congenital anomaly/birth defect, or requires intervention to prevent permanent impairment or damage.
Trial Locations
- Locations (21)
Dr. Diane Baker
🇺🇸Lake Oswego, Oregon, United States
Dr. Kevin Terry
🇺🇸Lutherville, Maryland, United States
Dr. Harry Penny
🇺🇸Altoona, Pennsylvania, United States
Dr. AnneMarie Uliasz
🇺🇸New York, New York, United States
Dr. Teresa Coats
🇺🇸Austin, Texas, United States
Dr. Joel Schlessinger
🇺🇸Omaha, Nebraska, United States
Dr. Boni Elewski
🇺🇸Birmingham, Alabama, United States
Dr. John Fenyk
🇺🇸Chaska, Minnesota, United States
Dr. David G. Armstrong
🇺🇸North Chicago, Illinois, United States
Dr. Robert Shouey
🇺🇸Harrisonburg, Virginia, United States
Dr. Anthony Puopolo
🇺🇸Milford, Massachusetts, United States
Dr. James Swinehart
🇺🇸Denver, Colorado, United States
Dr. John Barnes
🇺🇸Portland, Oregon, United States
Dr. Cynthia Strout
🇺🇸Mt. Pleasant, South Carolina, United States
Dr. Lawrence Parish
🇺🇸Philadelphia, Pennsylvania, United States
Novartis Investigative Site
🇮🇸Various cities, Iceland
Dr. Lawrence Harkless
🇺🇸San Antonio, Texas, United States
Dr. Willard Niemi
🇺🇸Raleigh, North Carolina, United States
Dr. Stacy Smith
🇺🇸San Diego, California, United States
Dr. Scott J. Ashton
🇺🇸Dallas, Texas, United States
Dr. Amit Pandya
🇺🇸Dallas, Texas, United States