Trial · NCT01270971
Efficacy and Safety Evaluation of AN2690 Topical Solution to Treat Onychomycosis of the Toenail
NCT01270971, Phase 3, Completed, Pfizer; results first posted 2014-08-15
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Efficacy and Safety Evaluation of AN2690 Topical Solution to Treat Onychomycosis of the Toenail. Trials, record NCT01270971. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01270971
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety Evaluation of AN2690 Topical Solution to Treat Onychomycosis of the Toenail
- NCT number
- NCT01270971
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 594 participants, actual
- Lead sponsor
- Pfizer
- Conditions
- Onychomycosis of Toenails
- Interventions
- AN2690 Topical Solution, 5%, Solution Vehicle
- First posted
- 2011-01-06
- Last updated
- 2019-02-22
- Results first posted
- 2014-08-15
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Complete Cure (Completely Clear Nail and Negative Mycology) of Target Great Toenail at Week 52 | 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. |
| Secondary | Completely Clear or Almost Clear Target Great Toenail at Week 52 | 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. |
| Secondary | Treatment Success (Completely Clear or Almost Clear Nail and Negative Mycology) of Target Great Toenail at Week 52 | 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. |
| Secondary | Negative Mycology of Target Great Toenail at Week 52 | Week 52 | Negative KOH and negative fungal culture. |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Complete Cure (Completely Clear Nail and Negative Mycology) of Target Great Toenail at Week 52 | Week 52 | 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. | participants | NUMBER |
| SECONDARY | Completely Clear or Almost Clear Target Great Toenail at Week 52 | Week 52 | Efficacy analysis was performed using the ITT population. The LOCF was used in order to provide a value for efficacy parameters that were missing. | participants | NUMBER |
| SECONDARY | Treatment Success (Completely Clear or Almost Clear Nail and Negative Mycology) of Target Great Toenail at Week 52 | Week 52 | Efficacy analysis was performed using the ITT population. The LOCF was used in order to provide a value for efficacy parameters that were missing. | participants | NUMBER |
| SECONDARY | Negative Mycology of Target Great Toenail at Week 52 | Week 52 | Efficacy analysis was performed using the ITT population. The LOCF was used in order to provide a value for efficacy parameters that were missing. | participants | NUMBER |
Source ClinicalTrials.gov
Results by group16
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Complete Cure (Completely Clear Nail and Negative Mycology) of Target Great Toenail at Week 52 | AN2690 Topical Solution, 5% | Success | 26 | participants | |
| Complete Cure (Completely Clear Nail and Negative Mycology) of Target Great Toenail at Week 52 | Solution Vehicle | Success | 1 | participants | |
| Complete Cure (Completely Clear Nail and Negative Mycology) of Target Great Toenail at Week 52 | AN2690 Topical Solution, 5% | Failure | 373 | participants | |
| Complete Cure (Completely Clear Nail and Negative Mycology) of Target Great Toenail at Week 52 | Solution Vehicle | Failure | 193 | participants | |
| Completely Clear or Almost Clear Target Great Toenail at Week 52 | AN2690 Topical Solution, 5% | Success | 104 | participants | |
| Completely Clear or Almost Clear Target Great Toenail at Week 52 | Solution Vehicle | Success | 18 | participants | |
| Completely Clear or Almost Clear Target Great Toenail at Week 52 | AN2690 Topical Solution, 5% | Failure | 295 | participants | |
| Completely Clear or Almost Clear Target Great Toenail at Week 52 | Solution Vehicle | Failure | 176 | participants | |
| Treatment Success (Completely Clear or Almost Clear Nail and Negative Mycology) of Target Great Toenail at Week 52 | AN2690 Topical Solution, 5% | Success | 61 | participants | |
| Treatment Success (Completely Clear or Almost Clear Nail and Negative Mycology) of Target Great Toenail at Week 52 | Solution Vehicle | Success | 3 | participants |
1 to 10 of 16Source ClinicalTrials.gov
See all 16 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | AN2690 Topical Solution, 5% | 400 | |
| Overall Study | STARTED | Solution Vehicle | 194 | |
| Overall Study | COMPLETED | AN2690 Topical Solution, 5% | 348 | |
| Overall Study | COMPLETED | Solution Vehicle | 171 | |
| Overall Study | NOT COMPLETED | AN2690 Topical Solution, 5% | 52 | |
| Overall Study | NOT COMPLETED | Solution Vehicle | 23 |
Source ClinicalTrials.gov
Adverse events56
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nasopharyngitis | Infections and infestations | AN2690 Topical Solution, 5% | 23 | 396 | |
| other | Nasopharyngitis | Infections and infestations | Solution Vehicle | 10 | 193 | |
| other | Tinea pedis | Infections and infestations | AN2690 Topical Solution, 5% | 42 | 396 | |
| other | Tinea pedis | Infections and infestations | Solution Vehicle | 35 | 193 | |
| other | Upper respiratory tract infection | Infections and infestations | AN2690 Topical Solution, 5% | 20 | 396 | |
| other | Upper respiratory tract infection | Infections and infestations | Solution Vehicle | 8 | 193 | |
| other | Influenza | Infections and infestations | AN2690 Topical Solution, 5% | 11 | 396 | |
| other | Influenza | Infections and infestations | Solution Vehicle | 10 | 193 | |
| serious | Anaemia (unrelated) | Blood and lymphatic system disorders | AN2690 Topical Solution, 5% | 0 | 396 | |
| serious | Anaemia (unrelated) | Blood and lymphatic system disorders | Solution Vehicle | 1 | 193 |
1 to 10 of 56Source ClinicalTrials.gov
See all 56 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | AN2690 Topical Solution, 5% | ||
| Total, all-cause mortality | Solution Vehicle | ||
| Total, other adverse events | AN2690 Topical Solution, 5% | 90 | 396 |
| Total, other adverse events | Solution Vehicle | 57 | 193 |
| Total, serious adverse events | AN2690 Topical Solution, 5% | 12 | 396 |
| Total, serious adverse events | Solution Vehicle | 8 | 193 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons1
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison |
|---|
| AN2690 Topical Solution, 5% vs Solution Vehicle: serious adverse events |
Source Trial comparisons
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT01270971
GET https://conductscience.org/api/trials/v1/NCT01270971/events?page=2