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Trial record 39 of 40 for:    Clotrimazole

Clinical Equivalence of Two Butenafine Hydrochloride 1% Creams in Patients With Interdigital Tinea Pedis

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ClinicalTrials.gov Identifier: NCT00835510
Recruitment Status : Completed
First Posted : February 3, 2009
Results First Posted : October 6, 2009
Last Update Posted : February 4, 2014
Sponsor:
Information provided by (Responsible Party):
Taro Pharmaceuticals USA

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: Butenafine cream 1% manufactured by Taro
Drug: Lotrimin Ultra (butenafine) 1%
Drug: Butenafine Vehicle manufactured by Taro
Enrollment 548

Recruitment Details Patients 12 years of age and older, who presented with interdigital tinea pedis, with a positive potassium hydroxide test (KOH) and met the inclusion/exclusion criteria were enrolled in the trial. Subsequently samples were sent for culture to confirm that either T. rubrum, T. mentagrophytes, or E. floccosum were the causative organism.
Pre-assignment Details  
Arm/Group Title Butenafine Cream 1% (Taro) Lotrimin Ultra (Butenafine) 1% Vehicle
Hide Arm/Group Description Butenafine cream manufactured by Taro applied for 7 days Lotrimin Ultra (butenafine) applied for 7 days Butenafine vehicle applied for 7 days
Period Title: Overall Study
Started 219 221 108
Positive Fungal Culture 149 155 71
Completed 143 152 70
Not Completed 76 69 38
Arm/Group Title Butenafine Cream 1% (Taro) Lotrimin Ultra (Butenafine) 1% Vehicle Total
Hide Arm/Group Description Butenafine cream manufactured by Taro applied for 7 days Lotrimin Ultra (butenafine) applied for 7 days Butenafine vehicle applied for 7 days Total of all reporting groups
Overall Number of Baseline Participants 149 155 71 375
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 149 participants 155 participants 71 participants 375 participants
<=18 years
4
   2.7%
6
   3.9%
2
   2.8%
12
   3.2%
Between 18 and 65 years
135
  90.6%
142
  91.6%
66
  93.0%
343
  91.5%
>=65 years
10
   6.7%
7
   4.5%
3
   4.2%
20
   5.3%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 149 participants 155 participants 71 participants 375 participants
Female
42
  28.2%
41
  26.5%
23
  32.4%
106
  28.3%
Male
107
  71.8%
114
  73.5%
48
  67.6%
269
  71.7%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 149 participants 155 participants 71 participants 375 participants
United States 123 135 62 320
Belize 26 20 9 55
1.Primary Outcome
Title Therapeutic Cure - Superiority Analysis
Hide Description

Therapeutic Cure requires both Clinical Cure and Mycological Cure.

Clinical Cure was based on the following signs and symptoms: fissuring, erythema, maceration, vesiculation, scaling, exudation, pruritus, burning. Each clinical symptom was evaluated using a 0-3 point rating scale: none=0, mild=1, moderate=2 or severe=3. If the score for erythema was ≤ 2 and the sum for all of the other 7 signs and symptoms was <2 then the patient was considered a Clinical Cure.

Mycological Cure: The potassium hydroxide (KOH) and the fungal culture were both negative.

Time Frame 42 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients with negative cultures at baseline are excluded. Efficacy ITT analysis includes all patients with positive baseline cultures, who received at least one dose of medication, had a follow-up visit and had data for the day 42 visit.
Arm/Group Title Butenafine Cream 1% (Taro) Lotrimin Ultra (Butenafine) 1% Vehicle
Hide Arm/Group Description:
Butenafine cream manufactured by Taro applied for 7 days
Lotrimin Ultra (butenafine) applied for 7 days
Butenafine vehicle applied for 7 days
Overall Number of Participants Analyzed 143 152 70
Measure Type: Number
Unit of Measure: Participants
76 108 24
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Butenafine Cream 1% (Taro), Vehicle
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0127
Comments [Not Specified]
Method Fisher Exact
Comments two-sided
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Lotrimin Ultra (Butenafine) 1%, Vehicle
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.0001
Comments [Not Specified]
Method Fisher Exact
Comments two-sided
2.Primary Outcome
Title Therapeutic Cure Non-Inferiority Comparison of Butenafine Cream and Lotrimin Ultra
Hide Description Patient was cured both by symptoms (Clinical Cure) and by the results of fungal testing (Mycological Cure).
Time Frame 42 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
Patients with negative cultures excluded. Use per protocol population
Arm/Group Title Butenafine Cream 1% (Taro) Lotrimin Ultra (Butenafine) 1% Vehicle
Hide Arm/Group Description:
Butenafine cream manufactured by Taro applied for 7 days
Lotrimin Ultra (butenafine) applied for 7 days
Butenafine vehicle applied for 7 days
Overall Number of Participants Analyzed 126 139 0
Measure Type: Number
Unit of Measure: Participants
63 97
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Butenafine Cream 1% (Taro), Lotrimin Ultra (Butenafine) 1%
Comments [Not Specified]
Type of Statistical Test Non-Inferiority or Equivalence
Comments The criteria for equivalence is that the 90% confidence interval for the difference in cure rate had to be between -20% to +20%.
Method of Estimation Estimation Parameter Cure rate difference
Estimated Value -19.78
Confidence Interval 90%
-30.27 to -9.29
Estimation Comments [Not Specified]
3.Secondary Outcome
Title Therapeutic Cure
Hide Description Subject with clinical and mycological cure at day 7
Time Frame 7 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT Population
Arm/Group Title Butenafine Cream 1% (Taro) Lotrimin Ultra (Butenafine) 1% Vehicle
Hide Arm/Group Description:
Butenafine cream manufactured by Taro applied for 7 days
Lotrimin Ultra (butenafine) applied for 7 days
Butenafine vehicle applied for 7 days
Overall Number of Participants Analyzed 149 153 71
Measure Type: Number
Unit of Measure: Participants
30 38 11
4.Secondary Outcome
Title Mycologic Cure
Hide Description Negative KOH and fungal culture at day 42
Time Frame 42 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Butenafine Cream 1% (Taro) Lotrimin Ultra (Butenafine) 1% Vehicle
Hide Arm/Group Description:
Butenafine cream manufactured by Taro applied for 7 days
Lotrimin Ultra (butenafine) applied for 7 days
Butenafine vehicle applied for 7 days
Overall Number of Participants Analyzed 141 152 70
Measure Type: Number
Unit of Measure: Participants
101 128 33
5.Secondary Outcome
Title Clinical Cure
Hide Description

The following 8 signs and symptoms are rated at each visit:

Erythema Fissuring Maceration Vesiculation Desquamation/scaling Exudation Pruritus Stinging/Burning

Each symptom is evaluated using the following scale:

0 = None- Complete absence of any sign or symptom

  1. = Mild – obvious but minimal involvement
  2. = Moderate – something that is easily noted
  3. = Severe – quite marked

Clinical cure is defined as a score of 2 (moderate) or less for erythema and a total score for seven other signs and symptoms less than 2.

Time Frame 42 days
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
ITT population
Arm/Group Title Butenafine Cream 1% (Taro) Lotrimin Ultra (Butenafine) 1% Vehicle
Hide Arm/Group Description:
Butenafine cream manufactured by Taro applied for 7 days
Lotrimin Ultra (butenafine) applied for 7 days
Butenafine vehicle applied for 7 days
Overall Number of Participants Analyzed 142 152 70
Measure Type: Number
Unit of Measure: Participants
83 111 27
6.Secondary Outcome
Title Safety and Adverse Event Profile
Hide Description [Not Specified]
Time Frame 42 days
Outcome Measure Data Not Reported
Time Frame Adverse event data was collected over the 42 day duration of the study.
Adverse Event Reporting Description The Safety Population includes all 548 patients who received at least a single dose of medication.
 
Arm/Group Title Butenafine Cream 1% (Taro) Lotrimin Ultra (Butenafine) 1% Vehicle
Hide Arm/Group Description Butenafine cream manufactured by Taro applied for 7 days Lotrimin Ultra (butenafine) applied for 7 days Butenafine vehicle applied for 7 days
All-Cause Mortality
Butenafine Cream 1% (Taro) Lotrimin Ultra (Butenafine) 1% Vehicle
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
Butenafine Cream 1% (Taro) Lotrimin Ultra (Butenafine) 1% Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   2      0      1    
Cardiac disorders       
Tachycardia * 1  1/219 (0.46%)  1 0/221 (0.00%)  0 0/108 (0.00%)  0
Infections and infestations       
Cellulitis * 1  1/219 (0.46%)  1 0/221 (0.00%)  0 1/108 (0.93%)  1
*
Indicates events were collected by non-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 2%
Butenafine Cream 1% (Taro) Lotrimin Ultra (Butenafine) 1% Vehicle
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   14      21      5    
Infections and infestations       
Nasopharyngitis * 1  4/219 (1.83%)  4 5/221 (2.26%)  5 1/108 (0.93%)  1
Nervous system disorders       
Headache * 1  10/219 (4.57%)  10 16/221 (7.24%)  16 4/108 (3.70%)  4
*
Indicates events were collected by non-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.
Results Point of Contact
Name/Title: Medical Director
Organization: Taro Pharmaceuticals
Phone: (914) 345-9001 ext 6427
Responsible Party: Taro Pharmaceuticals USA
ClinicalTrials.gov Identifier: NCT00835510     History of Changes
Other Study ID Numbers: BTNF-0708
First Submitted: January 30, 2009
First Posted: February 3, 2009
Results First Submitted: May 4, 2009
Results First Posted: October 6, 2009
Last Update Posted: February 4, 2014