A Phase 3 interventional study of AN2690 Topical Solution, 5% and Solution Vehicle in Onychomycosis of Toenails, sponsored by Pfizer. Completed at 32 sites in 2 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2019-04-03.
Sponsored by Pfizer · Phase 3, Interventional, and Treatment
The purpose of this study is to determine whether AN2690 topical solution is a safe and effective treatment for onychomycosis of the toenail.
147 studies on the registry are indexed under Onychomycosis; 13 are open to participants now.
This study's enrollment of 604 is above the median of 56 across 134 interventional studies indexed under Onychomycosis.
Browse Onychomycosis studies →Pfizer is the lead sponsor of 3,244 studies on the registry; 139 are open to participants now.
Of its 582 completed or terminated interventional studies of FDA-regulated products, 381 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
AN2690 Topical Solution, 5%
Drug: AN2690 Topical Solution, 5%
Solution Vehicle
Drug: Solution Vehicle
AN2690 Topical Solution, 5%, applied once daily for 48 weeks
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
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
Completely Clear or Almost Clear Target Great Toenail at Week 52
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
Treatment Success (Completely Clear or Almost Clear Nail and Negative Mycology) of Target Great Toenail at Week 52
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
Negative Mycology of Target Great Toenail at Week 52
Negative KOH and negative fungal culture.
Time frame: Week 52
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.
| Milestone | AN2690 Topical Solution, 5% | Solution Vehicle |
|---|---|---|
| Started | 399 | 205 |
| Completed | 349 | 177 |
| Not completed | 50 | 28 |
| Withdrew: Withdrawal by subject | 30 | 20 |
| Withdrew: Lost to follow-up | 10 | 4 |
| Withdrew: Adverse event | 2 | 1 |
| Withdrew: Non-compliance | 4 | 2 |
| Withdrew: Non-specific | 4 | 1 |
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.
| participants | AN2690 Topical Solution, 5% | Solution Vehicle |
|---|---|---|
| Success | 36 | 3 |
| Failure | 360 | 202 |
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.
| participants | AN2690 Topical Solution, 5% | Solution Vehicle |
|---|---|---|
| Success | 109 | 30 |
| Failure | 287 | 175 |
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.
| participants | AN2690 Topical Solution, 5% | Solution Vehicle |
|---|---|---|
| Success | 71 | 8 |
| Failure | 325 | 197 |
Negative KOH and negative fungal culture.
| participants | AN2690 Topical Solution, 5% | Solution Vehicle |
|---|---|---|
| Success | 142 | 25 |
| Failure | 254 | 180 |
Collected over Up to Week 52. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| AN2690 Topical Solution, 5% | — | 7/395 (1.8%) | 88/395 (22.3%) |
| Solution Vehicle | — | 2/202 (1%) | 48/202 (23.8%) |
| Event | AN2690 Topical Solution, 5% | Solution Vehicle |
|---|---|---|
| Bronchitis (unrelated)Infections and infestations | 0/395 | 1/202 |
| Carotid artery disease (unrelated)Nervous system disorders | 0/395 | 1/202 |
| Transient ischaemic attack (unrelated)Nervous system disorders | 0/395 | 1/202 |
| Aortic aneurysm (unrelated)Vascular disorders | 0/395 | 1/202 |
| Peripheral artery aneurysm (unrelated)Vascular disorders | 0/395 | 1/202 |
| Retinal artery occlusion (unrelated)Eye disorders | 1/395 | 0/202 |
| Appendicitis (unrelated)Infections and infestations | 1/395 | 0/202 |
| Cystitis (unrelated)Infections and infestations | 1/395 | 0/202 |
| Femur fracture (unrelated)Injury, poisoning and procedural complications | 1/395 | 0/202 |
| Arthralgia (unrelated)Musculoskeletal and connective tissue disorders | 1/395 | 0/202 |
| Event | AN2690 Topical Solution, 5% | Solution Vehicle |
|---|---|---|
| Tinea pedisInfections and infestations | 53/395 | 25/202 |
| NasopharyngitisInfections and infestations | 27/395 | 16/202 |
| Upper respiratory tract infectionInfections and infestations | 18/395 | 12/202 |
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(years) | AN2690 Topical Solution, 5% | Solution Vehicle | Total |
|---|---|---|---|
| Mean | 55.5 ± 11.5 | 55.4 ± 11.0 | 55.5 ± 11.3 |
| Sex: Female, Male(Participants) | AN2690 Topical Solution, 5% | Solution Vehicle | Total |
|---|---|---|---|
| Female | 73 | 31 | 104 |
| Male | 323 | 174 | 497 |
| Ethnicity (NIH/OMB)(Participants) | AN2690 Topical Solution, 5% | Solution Vehicle | Total |
|---|---|---|---|
| Hispanic or Latino | 57 | 30 | 87 |
| Not Hispanic or Latino | 339 | 175 | 514 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | AN2690 Topical Solution, 5% | Solution Vehicle | Total |
|---|---|---|---|
| American Indian or Alaska Native | 2 | 1 | 3 |
| Asian | 11 | 2 | 13 |
| Native Hawaiian or Other Pacific Islander | 2 | 1 | 3 |
| Black or African American | 21 | 14 | 35 |
| White | 355 | 183 | 538 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 5 | 4 | 9 |
| Region of Enrollment(participants) | AN2690 Topical Solution, 5% | Solution Vehicle | Total |
|---|---|---|---|
| United States | 315 | 165 | 480 |
| Canada | 81 | 40 | 121 |
This study is completed, as verified in Mar 2019. You cannot join it, but the record below documents what was studied.
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