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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
Sponsor:
Information provided by:
Novartis

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
Enrollment 526
Recruitment Details This randomized, double -blind, vehicle -controlled, multicenter, parallel group study was designed to assess the efficacy, safety and tolerability of a topical formulation of terbinafine hydrogen chloride 10% topical solution (TTS10%) applied daily in patients with toenail onychomycosis. Started 07 DEC 2006 and ending 27 JUN 2008.
Pre-assignment Details  
Arm/Group Title Terbinafine 24 Weeks Vehicle 24 Weeks Terbinafine 48 Weeks Vehicle 48 Weeks
Hide Arm/Group Description Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks Vehicle (placebo) for 24 weeks Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks Vehicle (placebo) for 48 weeks
Period Title: Overall Study
Started 133 130 135 128
Safety Population 131 [1] 129 134 126
Completed 112 111 [2] 117 111
Not Completed 21 19 18 17
Reason Not Completed
Adverse Event             1             1             0             0
Lack of Efficacy             3             2             1             1
Protocol Violation             2             1             2             1
Withdrawal by Subject             6             7             8             9
Lost to Follow-up             9             8             6             5
Administrative problems             0             0             0             1
Death             0             0             1             0
[1]
Participants who received study drug and had at least one post-baseline safety assessment.
[2]
A participant from this gr. discont'ed due to renal failure, was counted as an AE and also as a SAE.
Arm/Group Title Terbinafine 24 Weeks Vehicle 24 Weeks Terbinafine 48 Weeks Vehicle 48 Weeks Total
Hide Arm/Group Description Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks Vehicle (placebo) for 24 weeks Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks Vehicle (placebo) for 48 weeks Total of all reporting groups
Overall Number of Baseline Participants 133 130 135 128 526
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 133 participants 130 participants 135 participants 128 participants 526 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
1
   0.8%
1
   0.2%
Between 18 and 65 years
93
  69.9%
103
  79.2%
95
  70.4%
97
  75.8%
388
  73.8%
>=65 years
40
  30.1%
27
  20.8%
40
  29.6%
30
  23.4%
137
  26.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 133 participants 130 participants 135 participants 128 participants 526 participants
Female
34
  25.6%
39
  30.0%
41
  30.4%
35
  27.3%
149
  28.3%
Male
99
  74.4%
91
  70.0%
94
  69.6%
93
  72.7%
377
  71.7%
1.Primary Outcome
Title Efficacy Assessed by the Percentage of Participants With Complete Cure at the End of Study (Week 52) After Treating for 24 or 48 Weeks
Hide Description Complete cure is defined as negative KOH microscopy and negative culture for dermatophytes and no residual involvement of the target toenail.
Time Frame 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) population, Last observation carried forward (LOCF)
Arm/Group Title Terbinafine 24 Weeks Vehicle 24 Weeks Terbinafine 48 Weeks Vehicle 48 Weeks
Hide Arm/Group Description:
Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks
Vehicle (placebo) for 24 weeks
Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks
Vehicle (placebo) for 48 weeks
Overall Number of Participants Analyzed 133 130 135 128
Measure Type: Number
Unit of Measure: Percentage of participants
1.50 0.77 2.96 0
2.Secondary Outcome
Title Efficacy Assessed by the Percentage of Participants With Mycological Cure at the End of Study After Treating Participants for 24 or 48 Weeks
Hide Description Mycological cure is defined as negative KOH microscopy and negative culture for dermatophytes.
Time Frame 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) population, Last observation carried forward (LOCF)
Arm/Group Title Terbinafine 24 Weeks Vehicle 24 Weeks Terbinafine 48 Weeks Vehicle 48 Weeks
Hide Arm/Group Description:
Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks
Vehicle (placebo) for 24 weeks
Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks
Vehicle (placebo) for 48 weeks
Overall Number of Participants Analyzed 133 130 135 128
Measure Type: Number
Unit of Measure: Percentage of participants
15.04 6.15 22.22 7.81
3.Secondary Outcome
Title Efficacy Assessed by the Percentage of Participants With Clinical Effectiveness at the End of Study After Treating Participants for 24 or 48 Weeks
Hide Description

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
Time Frame 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Intent to treat (ITT) population, Last observation carried forward (LOCF)
Arm/Group Title Terbinafine 24 Weeks Vehicle 24 Weeks Terbinafine 48 Weeks Vehicle 48 Weeks
Hide Arm/Group Description:
Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks
Vehicle (placebo) for 24 weeks
Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks
Vehicle (placebo) for 48 weeks
Overall Number of Participants Analyzed 133 130 135 128
Measure Type: Number
Unit of Measure: Percentage of participants
3.01 0.77 5.93 0.78
4.Secondary Outcome
Title Safety and Tolerability Assessed by the Number of Participants With Adverse Events
Hide Description 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.
Time Frame 52 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Safety Population
Arm/Group Title Terbinafine 24 Weeks Vehicle 24 Weeks Terbinafine 48 Weeks Vehicle 48 Weeks
Hide Arm/Group Description:
Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks
Vehicle (placebo) for 24 weeks
Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks
Vehicle (placebo) for 48 weeks
Overall Number of Participants Analyzed 131 129 134 126
Measure Type: Number
Unit of Measure: Number of participants
At least 1 AE 80 72 94 87
At least 1 SAE 8 3 9 7
Study drug discontinued due to an AE 0 1 1 0
Death 0 0 1 0
Time Frame 52 weeks
Adverse Event Reporting Description Safety population consisting of all participants who had at least one dose of study drug and had at least one post-baseline safety assessment.
 
Arm/Group Title Terbinafine 24 Weeks Vehicle 24 Weeks Terbinafine 48 Weeks Vehicle 48 Weeks
Hide Arm/Group Description Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 24 weeks Vehicle (placebo) for 24 weeks Terbinafine hydrochloride (HCl) 10 % Nail Solution for Onychomycosis (NSO) for 48 weeks Vehicle (placebo) for 48 weeks
All-Cause Mortality
Terbinafine 24 Weeks Vehicle 24 Weeks Terbinafine 48 Weeks Vehicle 48 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Terbinafine 24 Weeks Vehicle 24 Weeks Terbinafine 48 Weeks Vehicle 48 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   8/131 (6.11%)   3/129 (2.33%)   9/134 (6.72%)   7/126 (5.56%) 
Cardiac disorders         
Acute coronary syndrome  1  1/131 (0.76%)  0/129 (0.00%)  0/134 (0.00%)  0/126 (0.00%) 
Angina pectoris  1  1/131 (0.76%)  0/129 (0.00%)  0/134 (0.00%)  0/126 (0.00%) 
Arrhythmia  1  1/131 (0.76%)  0/129 (0.00%)  0/134 (0.00%)  0/126 (0.00%) 
Myocardial infarction  1  1/131 (0.76%)  0/129 (0.00%)  1/134 (0.75%)  0/126 (0.00%) 
Tachycardia  1  0/131 (0.00%)  0/129 (0.00%)  0/134 (0.00%)  1/126 (0.79%) 
Gastrointestinal disorders         
Constipation  1  0/131 (0.00%)  0/129 (0.00%)  0/134 (0.00%)  1/126 (0.79%) 
Gastric ulcer  1  0/131 (0.00%)  1/129 (0.78%)  0/134 (0.00%)  0/126 (0.00%) 
Infections and infestations         
Cellulitis  1  0/131 (0.00%)  0/129 (0.00%)  1/134 (0.75%)  0/126 (0.00%) 
Pneumonia  1  0/131 (0.00%)  0/129 (0.00%)  0/134 (0.00%)  1/126 (0.79%) 
Injury, poisoning and procedural complications         
Near drowning  1  0/131 (0.00%)  0/129 (0.00%)  1/134 (0.75%)  0/126 (0.00%) 
Subdural haematoma  1  0/131 (0.00%)  0/129 (0.00%)  1/134 (0.75%)  0/126 (0.00%) 
Metabolism and nutrition disorders         
Hypocalcaemia  1  0/131 (0.00%)  0/129 (0.00%)  0/134 (0.00%)  1/126 (0.79%) 
Musculoskeletal and connective tissue disorders         
Back pain  1  0/131 (0.00%)  0/129 (0.00%)  1/134 (0.75%)  1/126 (0.79%) 
Intervertebral disc protrusion  1  0/131 (0.00%)  0/129 (0.00%)  1/134 (0.75%)  0/126 (0.00%) 
Osteoarthritis  1  0/131 (0.00%)  0/129 (0.00%)  1/134 (0.75%)  0/126 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Bladder cancer  1  1/131 (0.76%)  0/129 (0.00%)  0/134 (0.00%)  0/126 (0.00%) 
Bladder neoplasm  1  1/131 (0.76%)  0/129 (0.00%)  0/134 (0.00%)  0/126 (0.00%) 
Breast cancer  1  0/131 (0.00%)  0/129 (0.00%)  1/134 (0.75%)  0/126 (0.00%) 
Cervix carcinoma  1  0/131 (0.00%)  0/129 (0.00%)  1/134 (0.75%)  0/126 (0.00%) 
Malignant melanoma  1  1/131 (0.76%)  0/129 (0.00%)  0/134 (0.00%)  0/126 (0.00%) 
Malignant melanoma in situ  1  0/131 (0.00%)  0/129 (0.00%)  0/134 (0.00%)  1/126 (0.79%) 
Meningioma  1  0/131 (0.00%)  1/129 (0.78%)  0/134 (0.00%)  0/126 (0.00%) 
Prostate cancer  1  2/131 (1.53%)  0/129 (0.00%)  0/134 (0.00%)  0/126 (0.00%) 
Nervous system disorders         
Sciatica  1  0/131 (0.00%)  0/129 (0.00%)  0/134 (0.00%)  1/126 (0.79%) 
Renal and urinary disorders         
Bladder prolapse  1  0/131 (0.00%)  0/129 (0.00%)  0/134 (0.00%)  1/126 (0.79%) 
Dysuria  1  0/131 (0.00%)  0/129 (0.00%)  0/134 (0.00%)  1/126 (0.79%) 
Micturition disorder  1  0/131 (0.00%)  0/129 (0.00%)  0/134 (0.00%)  1/126 (0.79%) 
Renal failure  1  0/131 (0.00%)  1/129 (0.78%)  0/134 (0.00%)  0/126 (0.00%) 
Reproductive system and breast disorders         
Epididymitis  1  0/131 (0.00%)  0/129 (0.00%)  0/134 (0.00%)  1/126 (0.79%) 
Respiratory, thoracic and mediastinal disorders         
Dyspnoea  1  0/131 (0.00%)  0/129 (0.00%)  1/134 (0.75%)  0/126 (0.00%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Terbinafine 24 Weeks Vehicle 24 Weeks Terbinafine 48 Weeks Vehicle 48 Weeks
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   37/131 (28.24%)   38/129 (29.46%)   54/134 (40.30%)   52/126 (41.27%) 
Infections and infestations         
Influenza  1  2/131 (1.53%)  1/129 (0.78%)  13/134 (9.70%)  10/126 (7.94%) 
Nasopharyngitis  1  13/131 (9.92%)  11/129 (8.53%)  15/134 (11.19%)  15/126 (11.90%) 
Sinusitis  1  3/131 (2.29%)  0/129 (0.00%)  4/134 (2.99%)  7/126 (5.56%) 
Upper respiratory tract infection  1  4/131 (3.05%)  4/129 (3.10%)  4/134 (2.99%)  10/126 (7.94%) 
Musculoskeletal and connective tissue disorders         
Back pain  1  8/131 (6.11%)  7/129 (5.43%)  6/134 (4.48%)  12/126 (9.52%) 
Nervous system disorders         
Headache  1  21/131 (16.03%)  21/129 (16.28%)  28/134 (20.90%)  23/126 (18.25%) 
Vascular disorders         
Hypertension  1  1/131 (0.76%)  3/129 (2.33%)  8/134 (5.97%)  4/126 (3.17%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
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 terms and conditions of Novartis' agreements with its investigators may vary. However, Novartis does not prohibit any investigator from publishing. Any publications from a single-site are postponed until the publication of the pooled data (i.e., data from all sites) in the clinical trial.
Results Point of Contact
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862-778-8300
Responsible Party: External Affairs, Novartis Pharmaceuticals
ClinicalTrials.gov Identifier: NCT00443820     History of Changes
Other Study ID Numbers: CSFO327N2302
First Submitted: March 2, 2007
First Posted: March 6, 2007
Results First Submitted: January 19, 2011
Results First Posted: April 19, 2011
Last Update Posted: April 19, 2011