Trial Outcomes & Findings for Efficacy and Safety of AN2690 Topical Solution to Treat Onychomycosis of the Toenail (NCT NCT01302119)
NCT ID: NCT01302119
Last Updated: 2019-04-03
Results Overview
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.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
604 participants
Primary outcome timeframe
Week 52
Results posted on
2019-04-03
Participant Flow
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.
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.
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
399
|
205
|
|
Overall Study
COMPLETED
|
349
|
177
|
|
Overall Study
NOT COMPLETED
|
50
|
28
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
30
|
20
|
|
Overall Study
Lost to Follow-up
|
10
|
4
|
|
Overall Study
Adverse Event
|
2
|
1
|
|
Overall Study
Non-compliance
|
4
|
2
|
|
Overall Study
Non-specific
|
4
|
1
|
Baseline Characteristics
Efficacy and Safety of AN2690 Topical Solution to Treat Onychomycosis of the Toenail
Baseline characteristics by cohort
| Measure |
AN2690 Topical Solution, 5%
n=396 Participants
AN2690 Topical Solution, 5%
AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks
|
Solution Vehicle
n=205 Participants
Solution Vehicle
Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks
|
Total
n=601 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
55.5 years
STANDARD_DEVIATION 11.5 • n=5 Participants
|
55.4 years
STANDARD_DEVIATION 11.0 • n=7 Participants
|
55.5 years
STANDARD_DEVIATION 11.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
73 Participants
n=5 Participants
|
31 Participants
n=7 Participants
|
104 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
323 Participants
n=5 Participants
|
174 Participants
n=7 Participants
|
497 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
57 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
87 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
339 Participants
n=5 Participants
|
175 Participants
n=7 Participants
|
514 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
11 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
13 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
355 Participants
n=5 Participants
|
183 Participants
n=7 Participants
|
538 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
315 participants
n=5 Participants
|
165 participants
n=7 Participants
|
480 participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
81 participants
n=5 Participants
|
40 participants
n=7 Participants
|
121 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Week 52Population: 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.
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.
Outcome measures
| Measure |
AN2690 Topical Solution, 5%
n=396 Participants
AN2690 Topical Solution, 5%
AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks
|
Solution Vehicle
n=205 Participants
Solution Vehicle
Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks
|
|---|---|---|
|
Complete Cure (Completely Clear Nail and Negative Mycology) of Target Great Toenail at Week 52
Success
|
36 participants
|
3 participants
|
|
Complete Cure (Completely Clear Nail and Negative Mycology) of Target Great Toenail at Week 52
Failure
|
360 participants
|
202 participants
|
SECONDARY outcome
Timeframe: Week 52Population: Efficacy analysis was performed using the ITT population. The LOCF was used in order to provide a value for efficacy parameters that were missing.
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.
Outcome measures
| Measure |
AN2690 Topical Solution, 5%
n=396 Participants
AN2690 Topical Solution, 5%
AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks
|
Solution Vehicle
n=205 Participants
Solution Vehicle
Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks
|
|---|---|---|
|
Completely Clear or Almost Clear Target Great Toenail at Week 52
Success
|
109 participants
|
30 participants
|
|
Completely Clear or Almost Clear Target Great Toenail at Week 52
Failure
|
287 participants
|
175 participants
|
SECONDARY outcome
Timeframe: Week 52Population: Efficacy analysis was performed using the ITT population. The LOCF was used in order to provide a value for efficacy parameters that were missing.
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.
Outcome measures
| Measure |
AN2690 Topical Solution, 5%
n=396 Participants
AN2690 Topical Solution, 5%
AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks
|
Solution Vehicle
n=205 Participants
Solution Vehicle
Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks
|
|---|---|---|
|
Treatment Success (Completely Clear or Almost Clear Nail and Negative Mycology) of Target Great Toenail at Week 52
Success
|
71 participants
|
8 participants
|
|
Treatment Success (Completely Clear or Almost Clear Nail and Negative Mycology) of Target Great Toenail at Week 52
Failure
|
325 participants
|
197 participants
|
SECONDARY outcome
Timeframe: Week 52Population: Efficacy analysis was performed using the ITT population. The LOCF was used in order to provide a value for efficacy parameters that were missing.
Negative KOH and negative fungal culture.
Outcome measures
| Measure |
AN2690 Topical Solution, 5%
n=396 Participants
AN2690 Topical Solution, 5%
AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks
|
Solution Vehicle
n=205 Participants
Solution Vehicle
Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks
|
|---|---|---|
|
Negative Mycology of Target Great Toenail at Week 52
Success
|
142 participants
|
25 participants
|
|
Negative Mycology of Target Great Toenail at Week 52
Failure
|
254 participants
|
180 participants
|
Adverse Events
AN2690 Topical Solution, 5%
Serious events: 7 serious events
Other events: 88 other events
Deaths: 0 deaths
Solution Vehicle
Serious events: 2 serious events
Other events: 48 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
AN2690 Topical Solution, 5%
n=395 participants at risk
AN2690 Topical Solution, 5%
AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks
|
Solution Vehicle
n=202 participants at risk
Solution Vehicle
Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks
|
|---|---|---|
|
Eye disorders
Retinal artery occlusion (unrelated)
|
0.25%
1/395 • Up to Week 52
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.
|
0.00%
0/202 • Up to Week 52
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.
|
|
Infections and infestations
Appendicitis (unrelated)
|
0.25%
1/395 • Up to Week 52
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.
|
0.00%
0/202 • Up to Week 52
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.
|
|
Infections and infestations
Bronchitis (unrelated)
|
0.00%
0/395 • Up to Week 52
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.
|
0.50%
1/202 • Up to Week 52
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.
|
|
Infections and infestations
Cystitis (unrelated)
|
0.25%
1/395 • Up to Week 52
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.
|
0.00%
0/202 • Up to Week 52
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.
|
|
Injury, poisoning and procedural complications
Femur fracture (unrelated)
|
0.25%
1/395 • Up to Week 52
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.
|
0.00%
0/202 • Up to Week 52
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.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia (unrelated)
|
0.25%
1/395 • Up to Week 52
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.
|
0.00%
0/202 • Up to Week 52
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.
|
|
Nervous system disorders
Carotid artery disease (unrelated)
|
0.00%
0/395 • Up to Week 52
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.
|
0.50%
1/202 • Up to Week 52
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.
|
|
Nervous system disorders
Cerebrovascular accident (unrelated)
|
0.25%
1/395 • Up to Week 52
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.
|
0.00%
0/202 • Up to Week 52
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.
|
|
Nervous system disorders
Transient ischaemic attack (unrelated)
|
0.00%
0/395 • Up to Week 52
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.
|
0.50%
1/202 • Up to Week 52
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.
|
|
Psychiatric disorders
Anxiety (unrelated)
|
0.25%
1/395 • Up to Week 52
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.
|
0.00%
0/202 • Up to Week 52
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.
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism (unrelated)
|
0.25%
1/395 • Up to Week 52
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.
|
0.00%
0/202 • Up to Week 52
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.
|
|
Vascular disorders
Aortic aneurysm (unrelated)
|
0.00%
0/395 • Up to Week 52
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.
|
0.50%
1/202 • Up to Week 52
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.
|
|
Vascular disorders
Deep vein thrombosis (unrelated)
|
0.25%
1/395 • Up to Week 52
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.
|
0.00%
0/202 • Up to Week 52
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.
|
|
Vascular disorders
Peripheral artery aneurysm (unrelated)
|
0.00%
0/395 • Up to Week 52
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.
|
0.50%
1/202 • Up to Week 52
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.
|
Other adverse events
| Measure |
AN2690 Topical Solution, 5%
n=395 participants at risk
AN2690 Topical Solution, 5%
AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks
|
Solution Vehicle
n=202 participants at risk
Solution Vehicle
Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks
|
|---|---|---|
|
Infections and infestations
Tinea pedis
|
13.4%
53/395 • Up to Week 52
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.
|
12.4%
25/202 • Up to Week 52
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.
|
|
Infections and infestations
Nasopharyngitis
|
6.8%
27/395 • Up to Week 52
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.
|
7.9%
16/202 • Up to Week 52
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.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.6%
18/395 • Up to Week 52
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.
|
5.9%
12/202 • Up to Week 52
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee 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.
- Publication restrictions are in place
Restriction type: OTHER