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Efficacy, Safety, and Tolerability of Topical Terbinafine in Patients With Mild to Moderate Toenail Fungus of the Big Toenail

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00443898
First Posted: March 7, 2007
Last Update Posted: May 3, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis ( Novartis Pharmaceuticals )
Results First Submitted: January 19, 2011  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition: Onychomycosis
Interventions: Drug: terbinafine
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Terbinafine 24 w Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks
Vehicle 24 w vehicle (placebo) applied once daily for 24 weeks
Terbinafine 48 w Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks
Vehicle 48 w vehicle (placebo) applied once daily for 48 weeks

Participant Flow:   Overall Study
    Terbinafine 24 w   Vehicle 24 w   Terbinafine 48 w   Vehicle 48 w
STARTED   126   128   136   128 
COMPLETED   102   103   107   110 
NOT COMPLETED   24   25   29   18 
Adverse Event                0                0                1                1 
Lack of Efficacy                2                3                3                1 
Protocol Violation                1                1                1                0 
Withdrawal by Subject                11                10                10                6 
Lost to Follow-up                10                10                14                10 
Death                0                1                0                0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Terbinafine 24 w Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 24 weeks
Vehicle 24 w vehicle (placebo) applied once daily for 24 weeks
Terbinafine 48 w Active terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) applied once daily for 48 weeks
Vehicle 48 w vehicle (placebo) applied once daily for 48 weeks
Total Total of all reporting groups

Baseline Measures
   Terbinafine 24 w   Vehicle 24 w   Terbinafine 48 w   Vehicle 48 w   Total 
Overall Participants Analyzed 
[Units: Participants]
 126   128   136   128   518 
Age 
[Units: Participants]
         
<=18 years   0   0   0   0   0 
Between 18 and 65 years   107   101   116   100   424 
>=65 years   19   27   20   28   94 
Gender 
[Units: Participants]
         
Female   25   29   26   27   107 
Male   101   99   110   101   411 


  Outcome Measures
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1.  Primary:   Efficacy Assessed by Complete Cure Rate at the End of Study (Week 52) After Treating for 24 or 48 Weeks.   [ Time Frame: 52 weeks ]

2.  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.   [ Time Frame: 52 weeks ]

3.  Secondary:   Efficacy Assessed by Clinical Efficacy at the End of Study After Treating Patients for 24 or 48 Weeks.   [ Time Frame: 52 weeks ]

4.  Secondary:   Number of Participants Assessed With Adverse Events and Serious Adverse Events   [ Time Frame: 52 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
phone: 862-778-8300



Responsible Party: Novartis ( Novartis Pharmaceuticals )
ClinicalTrials.gov Identifier: NCT00443898     History of Changes
Other Study ID Numbers: CSFO327N2301
First Submitted: March 5, 2007
First Posted: March 7, 2007
Results First Submitted: January 19, 2011
Results First Posted: April 20, 2011
Last Update Posted: May 3, 2012