Multicenter Study of the Safety and Efficacy of NAFT-500 in Tinea Pedis

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merz Pharmaceuticals, LLC
ClinicalTrials.gov Identifier:
NCT00750139
First received: September 8, 2008
Last updated: April 19, 2013
Last verified: April 2013
Results First Received: February 13, 2012  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Safety/Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Conditions: Tinea Pedis
Athlete's Foot
Interventions: Drug: NAFT-500
Drug: Placebo 2-weeks
Drug: Naftin 1%
Drug: Placebo 4-weeks

  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
No text entered.

Reporting Groups
  Description
NAFT-500 Naftin 2% Cream applied daily for 2 weeks
Placebo 2-wks Placebo applied daily for 2-weeks
Naftin 1% Naftin 1% active comparator applied daily for 4 weeks
Placebo 4-wks Placebo cream applied daily for 4 weeks

Participant Flow:   Overall Study
    NAFT-500     Placebo 2-wks     Naftin 1%     Placebo 4-wks  
STARTED     234     118     236     119  
COMPLETED     145     59     135     73  
NOT COMPLETED     89     59     101     46  
Adverse Event                 1                 2                 0                 1  
Lost to Follow-up                 17                 12                 15                 6  
Withdrawal by Subject                 3                 2                 6                 2  
Physician Decision                 1                 1                 0                 0  
Non-compliance                 1                 0                 1                 3  
Termination by sponsor                 4                 0                 0                 1  
Non-specific                 62                 42                 79                 33  



  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.
No text entered.

Reporting Groups
  Description
NAFT-500 Naftin 2% Cream applied daily for 2 weeks
Placebo 2-wks Placebo applied daily for 2-weeks
Naftin 1% Naftin 1% active comparator applied daily for 4 weeks
Placebo 4-wks Placebo cream applied daily for 4 weeks
Total Total of all reporting groups

Baseline Measures
    NAFT-500     Placebo 2-wks     Naftin 1%     Placebo 4-wks     Total  
Number of Participants  
[units: participants]
  234     118     236     119     707  
Age  
[units: participants]
         
<=18 years     2     1     14     6     23  
Between 18 and 65 years     220     115     212     111     658  
>=65 years     12     2     10     2     26  
Age  
[units: years]
Mean ± Standard Deviation
  42.7  ± 13.03     41.0  ± 12.91     41.4  ± 14.08     41.4  ± 14.00     41.7  ± 13.52  
Gender  
[units: participants]
         
Female     63     38     71     33     205  
Male     171     80     165     86     502  
Region of Enrollment  
[units: participants]
         
United States     234     118     236     119     707  



  Outcome Measures
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1.  Primary:   Percentage of Subjects With Complete Cure at Week 6.   [ Time Frame: Week 6 ]

2.  Secondary:   Percentage of Subjects With Mycological Cure and Percentage of Subjects With Treatment Effectiveness at Week 6   [ Time Frame: Week 6 ]


  Serious Adverse Events


  Other Adverse Events


  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.


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.  


Results Point of Contact:  
Name/Title: Associate Medical Director- Dermatology
Organization: Merz Pharmaceuticals, LLC
phone: 800-334-0514


No publications provided


Responsible Party: Merz Pharmaceuticals, LLC
ClinicalTrials.gov Identifier: NCT00750139     History of Changes
Other Study ID Numbers: MUS 90200-0736/1
Study First Received: September 8, 2008
Results First Received: February 13, 2012
Last Updated: April 19, 2013
Health Authority: United States: Food and Drug Administration