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Trial record 15 of 16 for:    Belize

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

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.
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

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Butenafine Cream 1% (Taro) Butenafine cream manufactured by Taro applied for 7 days
Lotrimin Ultra (Butenafine) 1% Lotrimin Ultra (butenafine) applied for 7 days
Vehicle Butenafine vehicle applied for 7 days

Participant Flow:   Overall Study
    Butenafine Cream 1% (Taro)   Lotrimin Ultra (Butenafine) 1%   Vehicle
STARTED   219   221   108 
Positive Fungal Culture   149   155   71 
COMPLETED   143   152   70 
NOT COMPLETED   76   69   38 



  Baseline Characteristics

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
Butenafine Cream 1% (Taro) Butenafine cream manufactured by Taro applied for 7 days
Lotrimin Ultra (Butenafine) 1% Lotrimin Ultra (butenafine) applied for 7 days
Vehicle Butenafine vehicle applied for 7 days
Total Total of all reporting groups

Baseline Measures
   Butenafine Cream 1% (Taro)   Lotrimin Ultra (Butenafine) 1%   Vehicle   Total 
Overall Participants Analyzed 
[Units: Participants]
 149   155   71   375 
Age 
[Units: Participants]
       
<=18 years   4   6   2   12 
Between 18 and 65 years   135   142   66   343 
>=65 years   10   7   3   20 
Gender 
[Units: Participants]
       
Female   42   41   23   106 
Male   107   114   48   269 
Region of Enrollment 
[Units: Participants]
       
United States   123   135   62   320 
Belize   26   20   9   55 


  Outcome Measures

1.  Primary:   Therapeutic Cure - Superiority Analysis   [ Time Frame: 42 days ]

2.  Primary:   Therapeutic Cure Non-Inferiority Comparison of Butenafine Cream and Lotrimin Ultra   [ Time Frame: 42 days ]

3.  Secondary:   Therapeutic Cure   [ Time Frame: 7 days ]

4.  Secondary:   Mycologic Cure   [ Time Frame: 42 days ]

5.  Secondary:   Clinical Cure   [ Time Frame: 42 days ]

6.  Secondary:   Safety and Adverse Event Profile   [ Time Frame: 42 days ]
Results not yet reported.   Anticipated Reporting Date:   No text entered.  


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats

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
No text entered.


  More Information

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 Other disclosure agreement that restricts the right of the PI 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
e-mail: medical.affairs@taro.com



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