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Efficacy and Safety Evaluation of AN2690 Topical Solution to Treat Onychomycosis of the Toenail

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ClinicalTrials.gov Identifier: NCT01270971
Recruitment Status : Completed
First Posted : January 6, 2011
Results First Posted : August 15, 2014
Last Update Posted : August 15, 2014
Sponsor:
Information provided by (Responsible Party):
Pfizer

Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition: Onychomycosis of Toenails
Interventions: Drug: AN2690 Topical Solution, 5%
Drug: Solution Vehicle

  Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Subjects were screened and enrolled at thirty-four investigative centers in the United States and Mexico. The study population included men and women, 18 years of age and older who had distal subungual onychomycosis. The first subject visit occurred on December 1, 2010, and the last subject completed the Post Study Follow Up on January 8, 2013.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Eligible subjects were randomized in a 2:1 ratio to receive AN2690 Topical Solution, 5% or Solution Vehicle to be applied once daily to all affected toenails throughout the 48-week treatment period.

Reporting Groups
  Description
AN2690 Topical Solution, 5%

AN2690 Topical Solution, 5%

AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks

Solution Vehicle

Solution Vehicle

Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks


Participant Flow:   Overall Study
    AN2690 Topical Solution, 5%   Solution Vehicle
STARTED   400   194 
COMPLETED   348   171 
NOT COMPLETED   52   23 
Withdrawal by Subject                24                11 
Lost to Follow-up                18                5 
Adverse Event                1                2 
Non compliance                2                2 
Non-specific                7                3 



  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.
Analysis was performed using the intent-to-treat (ITT) population. Demographic characteristics were also analyzed using the Per Protocol (PP), Safety, and Post Study Follow Up (PSFU) populations, and were consistent with those of the ITT population. Safety analysis was performed using the Safety population.

Reporting Groups
  Description
AN2690 Topical Solution, 5%

AN2690 Topical Solution, 5%

AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks

Solution Vehicle

Solution Vehicle

Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks

Total Total of all reporting groups

Baseline Measures
   AN2690 Topical Solution, 5%   Solution Vehicle   Total 
Overall Participants Analyzed 
[Units: Participants]
 399   194   593 
Age 
[Units: Years]
Mean (Standard Deviation)
     
Age   53.6  (12.5)   53.4  (12.3)   53.5  (12.4) 
Gender 
[Units: Participants]
     
Female   75   36   111 
Male   324   158   482 
Ethnicity (NIH/OMB) 
[Units: Participants]
     
Hispanic or Latino   99   54   153 
Not Hispanic or Latino   300   140   440 
Unknown or Not Reported   0   0   0 
Race (NIH/OMB) 
[Units: Participants]
     
American Indian or Alaska Native   0   0   0 
Asian   2   0   2 
Native Hawaiian or Other Pacific Islander   0   0   0 
Black or African American   19   12   31 
White   316   152   468 
More than one race   0   0   0 
Unknown or Not Reported   62   30   92 
Region of Enrollment 
[Units: Participants]
     
United States   340   164   504 
Mexico   59   30   89 


  Outcome Measures

1.  Primary:   Complete Cure (Completely Clear Nail and Negative Mycology) of Target Great Toenail at Week 52   [ Time Frame: Week 52 ]

2.  Secondary:   Completely Clear or Almost Clear Target Great Toenail at Week 52   [ Time Frame: Week 52 ]

3.  Secondary:   Treatment Success (Completely Clear or Almost Clear Nail and Negative Mycology) of Target Great Toenail at Week 52   [ Time Frame: Week 52 ]

4.  Secondary:   Negative Mycology of Target Great Toenail at Week 52   [ Time Frame: Week 52 ]


  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
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  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 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: Sheryl Baldwin, RN/Associate Director
Organization: Anacor Pharmaceuticals, Inc.
phone: 650-223-8597
e-mail: clinicaltrials@anacor.com



Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01270971     History of Changes
Other Study ID Numbers: AN2690-ONYC-301
First Submitted: January 3, 2011
First Posted: January 6, 2011
Results First Submitted: July 25, 2014
Results First Posted: August 15, 2014
Last Update Posted: August 15, 2014