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Efficacy, Safety and Tolerability of Topical 10% Terbinafine Hydrogen Chloride Versus 5% Amorolfine Nail Lacquer in Patients With Mild to Moderate Toenail Onychomycosis

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ClinicalTrials.gov Identifier: NCT00459537
Recruitment Status : Completed
First Posted : April 12, 2007
Results First Posted : April 20, 2011
Last Update Posted : May 6, 2011
Sponsor:
Information provided by:
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Onychomycosis
Interventions Drug: terbinafine hydrogen chloride
Drug: amorolfine nail lacquer
Enrollment 1029
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Terbinafine Amorolfine
Hide Arm/Group Description 10% terbinafine hydrogen chloride (72.6 mg/ml nail lacquer). Patients applied one layer of the study medication once daily for 48 weeks, preferably at bedtime, to all affected toenails and allowed to dry. 5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails.
Period Title: Overall Study
Started 507 522
Safety Population 493 [1] 512
Completed 441 446
Not Completed 66 76
Reason Not Completed
Adverse Event             1             6
Lack of Efficacy             10             11
Withdrawal by Subject             20             26
Lost to Follow-up             27             30
Administrative problems             3             0
Protocol Violation             4             3
Missing             1             0
[1]
Participants who had at least one dose of study drug and one post-baseline safety assessment.
Arm/Group Title Terbinafine Amorolfine Total
Hide Arm/Group Description 10% terbinafine hydrogen chloride (72.6 mg/ml nail lacquer). Patients applied one layer of the study medication once daily for 48 weeks, preferably at bedtime, to all affected toenails and allowed to dry. 5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails. Total of all reporting groups
Overall Number of Baseline Participants 507 522 1029
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 507 participants 522 participants 1029 participants
<=18 years
0
   0.0%
1
   0.2%
1
   0.1%
Between 18 and 65 years
425
  83.8%
410
  78.5%
835
  81.1%
>=65 years
82
  16.2%
111
  21.3%
193
  18.8%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 507 participants 522 participants 1029 participants
Female
158
  31.2%
150
  28.7%
308
  29.9%
Male
349
  68.8%
372
  71.3%
721
  70.1%
1.Primary Outcome
Title Percentage of Participants With Complete Cure at the End of Study After Treating Participants for 48 Weeks
Hide Description Complete cure is defined as negative potassium hydroxide (KOH) microscopy and negative culture for dermatophytes and no residual involvement of the target toenail.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The Intent-to-treat population (ITT) population consisted of all patients who were randomized and dispensed study drug. Last Observation Carried Forward (LOCF)
Arm/Group Title Terbinafine Amorolfine
Hide Arm/Group Description:
10% terbinafine hydrogen chloride (72.6 mg/ml nail lacquer). Patients applied one layer of the study medication once daily for 48 weeks, preferably at bedtime, to all affected toenails and allowed to dry.
5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails.
Overall Number of Participants Analyzed 507 522
Measure Type: Number
Unit of Measure: Percentage of participants
1.18 0.96
2.Primary Outcome
Title Percentage of Participants With Complete Cure at the End of Study After Treating Participants for 48 Weeks.
Hide Description Complete cure is defined as negative potassium hydroxide (KOH) microscopy and negative culture for dermatophytes and no residual involvement of the target toenail.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The Per-protocol population (PP) consisted of ITT patients who completed the study without protocol deviations that led to exclusion according to criteria defined before database lock The per-protocol population was used to provide confirmation of efficacy findings from the ITT population. Last Observation Carried Forward (LOCF).
Arm/Group Title Terbinafine Amorolfine
Hide Arm/Group Description:
10% terbinafine hydrogen chloride (72.6 mg/ml nail lacquer). Patients applied one layer of the study medication once daily for 48 weeks, preferably at bedtime, to all affected toenails and allowed to dry.
5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails.
Overall Number of Participants Analyzed 260 266
Measure Type: Number
Unit of Measure: Percentage of participants
1.15 0.38
3.Secondary Outcome
Title Percentage of Participants With Clinical Effectiveness at the End of Study After Treating Patients for 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.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population, Last Observation Carried Forward (LOCF)
Arm/Group Title Terbinafine Amorolfine
Hide Arm/Group Description:
10% terbinafine hydrogen chloride (72.6 mg/ml nail lacquer). Patients applied one layer of the study medication once daily for 48 weeks, preferably at bedtime, to all affected toenails and allowed to dry.
5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails.
Overall Number of Participants Analyzed 507 522
Measure Type: Number
Unit of Measure: Percentage of participants
4.54 3.83
4.Secondary Outcome
Title Percentage of Participants With Mycological Cure at End of Study After Treating Patients for 48 Weeks
Hide Description Mycological cure is defined as negative KOH microscopy and negative culture for dermatophytes
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat population, Last Observation Carried Forward (LOCF)
Arm/Group Title Terbinafine Amorolfine
Hide Arm/Group Description:
10% terbinafine hydrogen chloride (72.6 mg/ml nail lacquer). Patients applied one layer of the study medication once daily for 48 weeks, preferably at bedtime, to all affected toenails and allowed to dry.
5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails.
Overall Number of Participants Analyzed 507 522
Measure Type: Number
Unit of Measure: Percentage of participants
16.17 15.71
5.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 or SAE and death. Additional details can be found in the Adverse Event Section.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
The Safety population consisted of all patients that received at least one dose of study drug and had at least one post-baseline safety assessment.
Arm/Group Title Terbinafine Amorolfine
Hide Arm/Group Description:
10% terbinafine hydrogen chloride (72.6 mg/ml nail lacquer). Patients applied one layer of the study medication once daily for 48 weeks, preferably at bedtime, to all affected toenails and allowed to dry.
5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails.
Overall Number of Participants Analyzed 493 512
Measure Type: Number
Unit of Measure: Participants
At least 1 AE 285 291
AE suspected related to study drug 11 7
At least 1 SAE 9 18
SAE suspected related to study drug 0 0
Death 0 0
Drug discontinuation due to an AE 1 5
Time Frame 52 weeks
Adverse Event Reporting Description Safety population consisting of all patients who received at least one dose of study drug and had at least one post-baseline safety assessment.
 
Arm/Group Title Terbinafine Amorolfine
Hide Arm/Group Description 10% terbinafine hydrogen chloride (72.6 mg/ml nail lacquer). Patients applied one layer of the study medication once daily for 48 weeks, preferably at bedtime, to all affected toenails and allowed to dry. 5% amorolfine nail lacquer. Patients applied study medication twice weekly for 48 weeks to all affected toenails.
All-Cause Mortality
Terbinafine Amorolfine
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
Terbinafine Amorolfine
Affected / at Risk (%) Affected / at Risk (%)
Total   9/493 (1.83%)   18/512 (3.52%) 
Blood and lymphatic system disorders     
Lymphadenopathy † 1  1/493 (0.20%)  0/512 (0.00%) 
Cardiac disorders     
Arteriosclerosis coronary artery † 1  0/493 (0.00%)  1/512 (0.20%) 
Atrial fibrillation † 1  0/493 (0.00%)  1/512 (0.20%) 
Cardiac failure † 1  0/493 (0.00%)  1/512 (0.20%) 
Coronary artery disease † 1  0/493 (0.00%)  1/512 (0.20%) 
Myocardial infarction † 1  0/493 (0.00%)  3/512 (0.59%) 
Ear and labyrinth disorders     
Vertigo † 1  0/493 (0.00%)  1/512 (0.20%) 
Endocrine disorders     
Thyroid cyst † 1  0/493 (0.00%)  1/512 (0.20%) 
Gastrointestinal disorders     
Abdominal pain upper † 1  0/493 (0.00%)  1/512 (0.20%) 
Enterovesical fistula † 1  1/493 (0.20%)  0/512 (0.00%) 
Oesophagitis † 1  0/493 (0.00%)  1/512 (0.20%) 
General disorders     
Chest pain † 1  0/493 (0.00%)  1/512 (0.20%) 
Hepatobiliary disorders     
Cholecystitis acute † 1  0/493 (0.00%)  1/512 (0.20%) 
Infections and infestations     
Appendicitis † 1  0/493 (0.00%)  1/512 (0.20%) 
Cystitis † 1  1/493 (0.20%)  0/512 (0.00%) 
Diverticulitis † 1  1/493 (0.20%)  0/512 (0.00%) 
Erysipelas † 1  1/493 (0.20%)  0/512 (0.00%) 
Peritonsillar abscess † 1  0/493 (0.00%)  1/512 (0.20%) 
Pneumonia † 1  0/493 (0.00%)  1/512 (0.20%) 
Pyelonephritis † 1  1/493 (0.20%)  0/512 (0.00%) 
Injury, poisoning and procedural complications     
Ligament rupture † 1  0/493 (0.00%)  1/512 (0.20%) 
Musculoskeletal and connective tissue disorders     
Haemarthrosis † 1  0/493 (0.00%)  1/512 (0.20%) 
Intervertebral disc displacement † 1  0/493 (0.00%)  1/512 (0.20%) 
Osteoarthritis † 1  1/493 (0.20%)  0/512 (0.00%) 
Pain in extremity † 1  0/493 (0.00%)  1/512 (0.20%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Breast cancer metastatic † 1  0/493 (0.00%)  1/512 (0.20%) 
Nervous system disorders     
Cerebrovascular accident † 1  0/493 (0.00%)  1/512 (0.20%) 
Transient ischaemic attack † 1  0/493 (0.00%)  1/512 (0.20%) 
Reproductive system and breast disorders     
Breast dysplasia † 1  0/493 (0.00%)  1/512 (0.20%) 
Surgical and medical procedures     
Cyst removal † 1  1/493 (0.20%)  0/512 (0.00%) 
Dupuytren's contracture operation † 1  1/493 (0.20%)  0/512 (0.00%) 
Vascular disorders     
Arterial stenosis † 1  1/493 (0.20%)  0/512 (0.00%) 
Arteriosclerosis † 1  0/493 (0.00%)  1/512 (0.20%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Terbinafine Amorolfine
Affected / at Risk (%) Affected / at Risk (%)
Total   186/493 (37.73%)   168/512 (32.81%) 
Infections and infestations     
Influenza † 1  25/493 (5.07%)  15/512 (2.93%) 
Nasopharyngitis † 1  69/493 (14.00%)  65/512 (12.70%) 
Tinea pedis † 1  29/493 (5.88%)  33/512 (6.45%) 
Musculoskeletal and connective tissue disorders     
Back pain † 1  26/493 (5.27%)  29/512 (5.66%) 
Nervous system disorders     
Headache † 1  98/493 (19.88%)  70/512 (13.67%) 
†
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA
[Not Specified]
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
Layout table for Results Point of Contact information
Name/Title: Study Director
Organization: Novartis Pharmaceuticals
Phone: 862 778-8300
Layout table for additonal information
Responsible Party: External Affairs, Novartis
ClinicalTrials.gov Identifier: NCT00459537    
Other Study ID Numbers: CSFO327N2303
First Submitted: April 10, 2007
First Posted: April 12, 2007
Results First Submitted: January 19, 2011
Results First Posted: April 20, 2011
Last Update Posted: May 6, 2011