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

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ClinicalTrials.gov Identifier: NCT01302119
Recruitment Status : Completed
First Posted : February 23, 2011
Results First Posted : August 15, 2014
Last Update Posted : April 3, 2019
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
Enrollment 604
Recruitment Details Subjects were screened and enrolled at forty-two investigative centers in the United States and Canada. The study population included men and women, 18 years of age and older who had distal subungual onychomycosis. The first subject visit occurred on February 2, 2011, and the last subject completed the Post Study Follow Up on February 20, 2013.
Pre-assignment Details 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.
Arm/Group Title AN2690 Topical Solution, 5% Solution Vehicle
Hide Arm/Group Description

AN2690 Topical Solution, 5%

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

Solution Vehicle

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

Period Title: Overall Study
Started 399 205
Completed 349 177
Not Completed 50 28
Reason Not Completed
Withdrawal by Subject             30             20
Lost to Follow-up             10             4
Adverse Event             2             1
Non-compliance             4             2
Non-specific             4             1
Arm/Group Title AN2690 Topical Solution, 5% Solution Vehicle Total
Hide Arm/Group Description

AN2690 Topical Solution, 5%

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

Solution Vehicle

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

Total of all reporting groups
Overall Number of Baseline Participants 396 205 601
Hide Baseline Analysis Population Description
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.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 396 participants 205 participants 601 participants
55.5  (11.5) 55.4  (11.0) 55.5  (11.3)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 396 participants 205 participants 601 participants
Female
73
  18.4%
31
  15.1%
104
  17.3%
Male
323
  81.6%
174
  84.9%
497
  82.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 396 participants 205 participants 601 participants
Hispanic or Latino
57
  14.4%
30
  14.6%
87
  14.5%
Not Hispanic or Latino
339
  85.6%
175
  85.4%
514
  85.5%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 396 participants 205 participants 601 participants
American Indian or Alaska Native
2
   0.5%
1
   0.5%
3
   0.5%
Asian
11
   2.8%
2
   1.0%
13
   2.2%
Native Hawaiian or Other Pacific Islander
2
   0.5%
1
   0.5%
3
   0.5%
Black or African American
21
   5.3%
14
   6.8%
35
   5.8%
White
355
  89.6%
183
  89.3%
538
  89.5%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
5
   1.3%
4
   2.0%
9
   1.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 396 participants 205 participants 601 participants
United States 315 165 480
Canada 81 40 121
1.Primary Outcome
Title Complete Cure (Completely Clear Nail and Negative Mycology) of Target Great Toenail at Week 52
Hide Description No clinical evidence of onychomycosis as evidenced by normal toenail plate, no onycholysis, and no subungual hyperkeratosis, and negative KOH wet mount and negative fungal culture.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis was performed using the ITT population. The last observation was carried forward (LOCF) in order to provide a value for efficacy parameters that were missing.
Arm/Group Title AN2690 Topical Solution, 5% Solution Vehicle
Hide Arm/Group Description:

AN2690 Topical Solution, 5%

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

Solution Vehicle

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

Overall Number of Participants Analyzed 396 205
Measure Type: Number
Unit of Measure: participants
Success 36 3
Failure 360 202
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AN2690 Topical Solution, 5%, Solution Vehicle
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
2.Secondary Outcome
Title Completely Clear or Almost Clear Target Great Toenail at Week 52
Hide Description No clinical evidence of onychomycosis as evidenced by normal toenail plate, no onycholysis, and no subungual hyperkeratosis, or no more than minimal evidence of onychomycosis as evidenced by toenail plate dystrophic or discolored over ≤ 10% of the distal aspect, with minimally evident onycholysis and subungual hyperkeratosis.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis was performed using the ITT population. The LOCF was used in order to provide a value for efficacy parameters that were missing.
Arm/Group Title AN2690 Topical Solution, 5% Solution Vehicle
Hide Arm/Group Description:

AN2690 Topical Solution, 5%

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

Solution Vehicle

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

Overall Number of Participants Analyzed 396 205
Measure Type: Number
Unit of Measure: participants
Success 109 30
Failure 287 175
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AN2690 Topical Solution, 5%, Solution Vehicle
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
3.Secondary Outcome
Title Treatment Success (Completely Clear or Almost Clear Nail and Negative Mycology) of Target Great Toenail at Week 52
Hide Description No clinical evidence of onychomycosis as evidenced by normal toenail plate, no onycholysis, and no subungual hyperkeratosis, or no more than minimal evidence of onychomycosis as evidenced by toenail plate dystrophic or discolored over ≤ 10% of the distal aspect, with minimally evident onycholysis and subungual hyperkeratosis, and negative KOH wet mount and negative fungal culture.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis was performed using the ITT population. The LOCF was used in order to provide a value for efficacy parameters that were missing.
Arm/Group Title AN2690 Topical Solution, 5% Solution Vehicle
Hide Arm/Group Description:

AN2690 Topical Solution, 5%

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

Solution Vehicle

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

Overall Number of Participants Analyzed 396 205
Measure Type: Number
Unit of Measure: participants
Success 71 8
Failure 325 197
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AN2690 Topical Solution, 5%, Solution Vehicle
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
4.Secondary Outcome
Title Negative Mycology of Target Great Toenail at Week 52
Hide Description Negative KOH and negative fungal culture.
Time Frame Week 52
Hide Outcome Measure Data
Hide Analysis Population Description
Efficacy analysis was performed using the ITT population. The LOCF was used in order to provide a value for efficacy parameters that were missing.
Arm/Group Title AN2690 Topical Solution, 5% Solution Vehicle
Hide Arm/Group Description:

AN2690 Topical Solution, 5%

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

Solution Vehicle

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

Overall Number of Participants Analyzed 396 205
Measure Type: Number
Unit of Measure: participants
Success 142 25
Failure 254 180
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection AN2690 Topical Solution, 5%, Solution Vehicle
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments [Not Specified]
Time Frame Up to Week 52
Adverse Event Reporting Description An AE was any unfavorable and unintended sign,symptom,or disease temporally associated with the use of the investigational product. A serious AE resulted in death,was life-threatening,required or prolonged in-patient hospitalization,persistent or significant disability/incapacity,resulted in a congenital anomaly,or was an important medical event.
 
Arm/Group Title AN2690 Topical Solution, 5% Solution Vehicle
Hide Arm/Group Description

AN2690 Topical Solution, 5%

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

Solution Vehicle

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

All-Cause Mortality
AN2690 Topical Solution, 5% Solution Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Hide Serious Adverse Events
AN2690 Topical Solution, 5% Solution Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   7/395 (1.77%)   2/202 (0.99%) 
Eye disorders     
Retinal artery occlusion (unrelated)  1  1/395 (0.25%)  0/202 (0.00%) 
Infections and infestations     
Appendicitis (unrelated)  1  1/395 (0.25%)  0/202 (0.00%) 
Bronchitis (unrelated)  1  0/395 (0.00%)  1/202 (0.50%) 
Cystitis (unrelated)  1  1/395 (0.25%)  0/202 (0.00%) 
Injury, poisoning and procedural complications     
Femur fracture (unrelated)  1  1/395 (0.25%)  0/202 (0.00%) 
Musculoskeletal and connective tissue disorders     
Arthralgia (unrelated)  1  1/395 (0.25%)  0/202 (0.00%) 
Nervous system disorders     
Carotid artery disease (unrelated)  1  0/395 (0.00%)  1/202 (0.50%) 
Cerebrovascular accident (unrelated)  1  1/395 (0.25%)  0/202 (0.00%) 
Transient ischaemic attack (unrelated)  1  0/395 (0.00%)  1/202 (0.50%) 
Psychiatric disorders     
Anxiety (unrelated)  1  1/395 (0.25%)  0/202 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Pulmonary embolism (unrelated)  1  1/395 (0.25%)  0/202 (0.00%) 
Vascular disorders     
Aortic aneurysm (unrelated)  1  0/395 (0.00%)  1/202 (0.50%) 
Deep vein thrombosis (unrelated)  1  1/395 (0.25%)  0/202 (0.00%) 
Peripheral artery aneurysm (unrelated)  1  0/395 (0.00%)  1/202 (0.50%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MeDRA 13.1
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
AN2690 Topical Solution, 5% Solution Vehicle
Affected / at Risk (%) Affected / at Risk (%)
Total   88/395 (22.28%)   48/202 (23.76%) 
Infections and infestations     
Tinea pedis  1  53/395 (13.42%)  25/202 (12.38%) 
Nasopharyngitis  1  27/395 (6.84%)  16/202 (7.92%) 
Upper respiratory tract infection  1  18/395 (4.56%)  12/202 (5.94%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, MeDRA 13.1
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.
Institution or Principal Investigator may only publish Study results after: (i) the results of the multicenter Study in its entirety have been publicly disclosed by the Sponsor in an abstract, manuscript or presentation form, or (ii) two (2) years after conclusion of the Study at all sites, whichever is first to occur.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Pfizer ClinicalTrials.gov Call Center
Organization: Pfizer, Inc.
Phone: 1-800-718-1021
EMail: ClinicalTrials.gov_Inquiries@Pfizer.com
Layout table for additonal information
Responsible Party: Pfizer
ClinicalTrials.gov Identifier: NCT01302119    
Other Study ID Numbers: AN2690-ONYC-302
First Submitted: February 21, 2011
First Posted: February 23, 2011
Results First Submitted: July 25, 2014
Results First Posted: August 15, 2014
Last Update Posted: April 3, 2019