Efficacy and Safety of NAFT-600 in Subjects With Tinea Pedis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merz Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT01289015
First received: January 28, 2011
Last updated: July 26, 2013
Last verified: July 2013
Results First Received: July 26, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Tinea Pedis
Interventions: Drug: NAFT-600 ( naftin 2 % gel )
Drug: Placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
NAFT-600 NAFT-600 : Topical; applied once daily for two weeks
Placebo Placebo : Topical; applied once daily for two weeks

Participant Flow:   Overall Study
    NAFT-600     Placebo  
STARTED     571     284  
COMPLETED     472     230  
NOT COMPLETED     99     54  
Protocol Violation                 12                 9  
Adverse Event                 3                 0  
Lost to Follow-up                 33                 17  
Withdrawal by Subject                 17                 8  
Disease progression                 1                 0  
Negative baseline culture and others                 33                 20  



  Baseline Characteristics
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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.
The Safety Evaluation Set (SES) which is the population of subjects who received at least one dose of study medication was used.

Reporting Groups
  Description
NAFT-600 NAFT-600 : Topical; applied once daily for two weeks
Placebo Placebo : Topical; applied once daily for two weeks
Total Total of all reporting groups

Baseline Measures
    NAFT-600     Placebo     Total  
Number of Participants  
[units: participants]
  571     284     855  
Age  
[units: participants]
     
<=18 years     5     2     7  
Between 18 and 65 years     524     255     779  
>=65 years     42     27     69  
Age  
[units: years]
Mean ± Standard Deviation
  45.3  ± 13.3     46.4  ± 14.3     45.7  ± 13.6  
Gender  
[units: participants]
     
Female     416     221     637  
Male     155     63     218  
Region of Enrollment  
[units: participants]
     
United States     545     271     816  
Puerto Rico     26     13     39  



  Outcome Measures
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1.  Primary:   Complete Cure of Interdigital Tinea Pedis   [ Time Frame: Visit 4/ Week 6 ]

2.  Secondary:   Effective Treatment and Mycological Cure of Interdigital Tinea Pedis at Week 6   [ Time Frame: Visit 4/ Week 6. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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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
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  More Information
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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 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 more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Stefan Plaum, MD Associate Medical Director
Organization: Merz Pharmaceuticals, LLC
phone: 800-334-0514
e-mail: clinicaltrials@merzusa.com


No publications provided


Responsible Party: Merz Pharmaceuticals, LLC
ClinicalTrials.gov Identifier: NCT01289015     History of Changes
Other Study ID Numbers: MRZ 90200/3015/1
Study First Received: January 28, 2011
Results First Received: July 26, 2013
Last Updated: July 26, 2013
Health Authority: United States: Food and Drug Administration