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: NCT00443820 |
Recruitment Status
:
Completed
First Posted
: March 6, 2007
Results First Posted
: April 19, 2011
Last Update Posted
: April 19, 2011
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Onychomycosis | Drug: terbinafine Drug: Placebo | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 526 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 |
Actual Study Completion Date : | June 2008 |

Arm | Intervention/treatment |
---|---|
Experimental: 1
Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks
|
Drug: terbinafine
Terbinafine hydrochloride (HCl) 10 % nail solution for onychomycosis (NSO) once daily for 48 weeks
Other Name: Lamisil
|
Placebo Comparator: 2
Vehicle (placebo) for 48 weeks
|
Drug: Placebo
Vehicle (placebo) once daily for 48 weeks
|
Experimental: 3
Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks
|
Drug: terbinafine
Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis once daily for 24 weeks
Other Name: Lamisil
|
Placebo Comparator: 4
Vehicle (placebo) for 24 weeks
|
Drug: Placebo
Vehicle (placebo) once daily for 24 weeks
|
- Efficacy Assessed by the Percentage of Participants With Complete Cure 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.
- Efficacy Assessed by the Percentage of Participants With Mycological Cure at the End of Study After Treating Participants for 24 or 48 Weeks [ Time Frame: 52 weeks ]Mycological cure is defined as negative KOH microscopy and negative culture for dermatophytes.
- Efficacy Assessed by the Percentage of Participants With Clinical Effectiveness at the End of Study After Treating Participants 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:
- If mycological cure (negative KOH and negative culture for dermatophytes) and
- = 10% residual involvement of the target toenail "No" if otherwise
- Safety and Tolerability Assessed by the Number of Participants With Adverse Events [ Time Frame: 52 weeks ]Safety and tolerability data as assessed by the number of participants with Adverse Events (AE), Serious Adverse Events, Drug discontinuation due to an AE and death. Additional details can be found in the Adverse Event Section.

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Ages Eligible for Study: | 12 Years to 75 Years (Child, Adult, Senior) |
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 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
- 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): NCT00443820

Study Director: | Novartis Pharmaceuticals | Novartis Pharmaceuticals |
Responsible Party: | External Affairs, Novartis Pharmaceuticals |
ClinicalTrials.gov Identifier: | NCT00443820 History of Changes |
Other Study ID Numbers: |
CSFO327N2302 |
First Posted: | March 6, 2007 Key Record Dates |
Results First Posted: | April 19, 2011 |
Last Update Posted: | April 19, 2011 |
Last Verified: | March 2011 |
Keywords provided by Novartis:
Toenail fungus Onychomycosis Nail fungus Toenail fungal infection |
Tinea unguium Dermatophytes Foot dermatoses |
Additional relevant MeSH terms:
Onychomycosis Tinea Dermatomycoses Skin Diseases, Infectious Infection Mycoses Nail Diseases |
Skin Diseases Pharmaceutical Solutions Terbinafine Antifungal Agents Anti-Infective Agents Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action |