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Trial record 12 of 39 for:    Terbinafine

Efficacy and Safety of Terbinafine Film Forming Solution in Patients With Tinea Pedis

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ClinicalTrials.gov Identifier: NCT01433107
Recruitment Status : Completed
First Posted : September 13, 2011
Results First Posted : December 27, 2013
Last Update Posted : December 27, 2013
Sponsor:
Information provided by (Responsible Party):
Novartis

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Tinea Pedis
Interventions Drug: Terbinafine
Drug: Terbinafine Placebo
Enrollment 290
Recruitment Details Study start 27 Aug 2011 end 14 Feb 2012
Pre-assignment Details Each particiapant received a single dose of Terbinafine Film Forming Solution 1% or matching placebo
Arm/Group Title Terbinafine Placebo
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Period Title: Overall Study
Started 145 145
Completed 118 128
Not Completed 27 17
Arm/Group Title Terbinafine Placebo Total
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Overall Number of Baseline Participants 145 145 290
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[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 145 participants 145 participants 290 participants
35.27  (12.805) 34.05  (11.936) 34.66  (12.372)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 145 participants 145 participants 290 participants
Female
50
  34.5%
46
  31.7%
96
  33.1%
Male
95
  65.5%
99
  68.3%
194
  66.9%
1.Primary Outcome
Title Effective Treatment Outcome (Direct Microscopy and Culture Negative and Total Signs and Symptom Score Less or Equal to 2)
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Each clinical sign or symptom will be assessed separately. The investigator will evaluate the severity of each sign or symptom over the entire target foot. Clinical signs and symptoms including desquamation (scaling), erythema, incrustation (crusting), pustules, vesiculation and pruritus will be evaluated by the investigator or designee and recorded at every visit using the following scale:

0 = absent

  1. = mild
  2. = moderate
  3. = severe In order to calculate the total symptoms score the rating for all symptoms are added up.

Possible range 0 to 18

Time Frame week 6
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Hide Analysis Population Description
Number of success. The discrepancy between number of participants analyzed and participants completed is explained by delayed exclusions (people having negative mycology results received after completion of the study).
Arm/Group Title Terbinafine Placebo
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Drug
Drug
Overall Number of Participants Analyzed 115 122
Measure Type: Number
Unit of Measure: participants
73 10
2.Secondary Outcome
Title Total Clinical Signs and Symptoms (S/S) Scores
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Each clinical sign or symptom will be assessed separately. The investigator will evaluate the severity of each sign or symptom over the entire target foot. Clinical signs and symptoms including desquamation (scaling), erythema, incrustation (crusting), pustules, vesiculation and pruritus will be evaluated by the investigator or designee and recorded at every visit using the following scale:

0 = absent

  1. = mild
  2. = moderate
  3. = severe In order to calculate the total symptom score, the scores for each individual symptom are added up.

Possible range : 0 to 18

Time Frame week 6
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Terbinafine Placebo
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Drug
Drug
Overall Number of Participants Analyzed 113 121
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
1.6
(1.3 to 2.0)
4.7
(4.1 to 5.2)
3.Secondary Outcome
Title Number of Subjects With Adverse Event
Hide Description Number of Subjects with adverse event
Time Frame 6 weeks
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Hide Analysis Population Description
Number of subject with any adverse events mild or moderate having signed the informed consent. One subject had an adverse event but did not receive any study drug and was not included in the number of subjects started.
Arm/Group Title Terbinafine Placebo
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Drug
Drug
Overall Number of Participants Analyzed 146 144
Measure Type: Number
Unit of Measure: participants
9 11
Time Frame [Not Specified]
Adverse Event Reporting Description One subject had an adverse event but did not receive any study drug and was not included in the number of subjects started.
 
Arm/Group Title Terbinafine Placebo
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All-Cause Mortality
Terbinafine Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Terbinafine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/146 (0.00%)      0/144 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 4%
Terbinafine Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/146 (0.00%)      7/144 (4.86%)    
General disorders     
General Disorders  1  0/146 (0.00%)  0 7/144 (4.86%)  7
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.
Preliminary agreement between Novartis Consumer Health and the investigator
Results Point of Contact
Name/Title: Clinical Project leader
Organization: Novartis
Phone: +41223633111
Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT01433107     History of Changes
Other Study ID Numbers: 727-D-301
First Submitted: September 8, 2011
First Posted: September 13, 2011
Results First Submitted: April 8, 2013
Results First Posted: December 27, 2013
Last Update Posted: December 27, 2013