Efficacy, Safety, and Tolerability of Topical Terbinafine in Patients With Mild to Moderate Toenail Fungus of the Big Toenail
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ClinicalTrials.gov Identifier: NCT00443898 |
Recruitment Status :
Completed
First Posted : March 7, 2007
Results First Posted : April 20, 2011
Last Update Posted : May 3, 2012
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Onychomycosis | Drug: terbinafine Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 518 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Double (Participant, Investigator) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double-blind, Vehicle-controlled, Multicenter, Parallel Group Study to Assess the Efficacy, Safety, and Tolerability of Topical Terbinafine Hydrogen Chloride (HCl) Formulation for 24 or 48 Weeks of Treatment in Patients With Mild to Moderate Toenail Onychomycosis |
Study Start Date : | December 2006 |
Actual Primary Completion Date : | June 2008 |
Arm | Intervention/treatment |
---|---|
Experimental: 1
Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks
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Drug: terbinafine
Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) once daily for 48 weeks
Other Name: Lamisil |
Placebo Comparator: 2
vehicle (placebo) applied once daily for 48 weeks
|
Drug: Placebo
vehicle (placebo) applied once daily for 48 weeks |
Experimental: 3
Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks
|
Drug: terbinafine
Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) once daily for 24 weeks
Other Name: Lamisil |
Placebo Comparator: 4
vehicle (placebo) applied once daily for 24 weeks
|
Drug: Placebo
vehicle (placebo) applied once daily for 24 weeks |
- Efficacy Assessed by Complete Cure Rate at the End of Study (Week 52) After Treating for 24 or 48 Weeks. [ Time Frame: 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
- Efficacy Assessed by Mycological Cure (Negative Culture and Negative KOH Microscopy) at the End of Study After Treating Patients for 24 or 48 Weeks. [ Time Frame: 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. [ Time Frame: 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 otherwise
- Number of Participants Assessed With Adverse Events and Serious Adverse Events [ Time Frame: 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.

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 12 Years to 75 Years (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00443898

Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00443898 |
Other Study ID Numbers: |
CSFO327N2301 |
First Posted: | March 7, 2007 Key Record Dates |
Results First Posted: | April 20, 2011 |
Last Update Posted: | May 3, 2012 |
Last Verified: | May 2012 |
Toenail fungus Onychomycosis Nail fungus Toenail fungal infection |
Tinea unguium Dermatophytes Foot dermatoses |
Onychomycosis Tinea Dermatomycoses Skin Diseases, Infectious Infection Mycoses Nail Diseases |
Skin Diseases Terbinafine Antifungal Agents Anti-Infective Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |