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A Study of Econazole Foam 1% in Athlete's Foot

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
AmDerma
ClinicalTrials.gov Identifier:
NCT00768599
First received: October 7, 2008
Last updated: December 5, 2012
Last verified: December 2012
Results First Received: December 5, 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: Econazole Nitrate Cream 1%
Drug: Econazole Nitrate Foam 1%
Drug: Vehicle Foam

  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
One-hundred and ninety-eight (198) subjects were screened and 135 were enrolled/randomized in the study. Subjects with negative KOH evaluations in both regions (all scrapings negative) were considered Screen Failures and were not enrolled into the study. Subject enrollment and completion dates are March 27, 2008 - September 25, 2008.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Subjects who met the inclusion/exclusion criteria were randomized to receive Econazole Nitrate Foam 1%, Econazole Nitrate Cream 1%, or Foam vehicle in a 1:1:1 ratio.

Reporting Groups
  Description
Reference Drug Econazole Nitrate Cream 1%
Test Drug Econazole Nitrate Foam 1%
Control Vehicle Foam

Participant Flow:   Overall Study
    Reference Drug     Test Drug     Control  
STARTED     45     43     47  
COMPLETED     34     27     35  
NOT COMPLETED     11     16     12  



  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.
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Reporting Groups
  Description
Reference Drug Econazole Nitrate Cream 1%
Test Drug Econazole Nitrate Foam 1%
Control Vehicle Foam
Total Total of all reporting groups

Baseline Measures
    Reference Drug     Test Drug     Control     Total  
Number of Participants  
[units: participants]
  45     43     47     135  
Age  
[units: participants]
       
<=18 years     0     0     0     0  
Between 18 and 65 years     40     39     47     126  
>=65 years     5     4     0     9  
Age  
[units: years]
Mean ± Standard Deviation
  45.4  ± 15.9     44.2  ± 14.5     43.1  ± 10.8     44.2  ± 13.8  
Gender  
[units: participants]
       
Female     10     9     12     31  
Male     35     34     35     104  
Region of Enrollment  
[units: participants]
       
United States     45     43     47     135  
Weight  
[units: lbs]
Mean ± Standard Deviation
  194.4  ± 45.49     199.5  ± 56.06     207.0  ± 49.75     200.4  ± 50.42  



  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Complete Cure Rate: Interdigital Disease   [ Time Frame: Day 43 ]

2.  Primary:   Complete Cure Rate: Moccasin Disease   [ Time Frame: 43 Days ]

3.  Secondary:   Effective Treatment: Interdigital Disease   [ Time Frame: 43 ]

4.  Secondary:   Effective Treatment: Mocassin Disease   [ Time Frame: 43 ]

5.  Secondary:   Mycological Cure: Interdigital Disease   [ Time Frame: 43 ]

6.  Secondary:   Mycological Cure: Mocassin Disease   [ Time Frame: 43 ]


  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: Candis Edwards
Organization: AmDerma Pharmaceuticals
phone: 631-974-7949
e-mail: cedwards@amderma.com


No publications provided


Responsible Party: AmDerma
ClinicalTrials.gov Identifier: NCT00768599     History of Changes
Other Study ID Numbers: D79-2902-07
Study First Received: October 7, 2008
Results First Received: December 5, 2012
Last Updated: December 5, 2012
Health Authority: United States: Food and Drug Administration