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The purpose of this study is to determine whether AN2690 topical solution is a safe and effective treatment for onychomycosis of the toenail.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| AN2690 Topical Solution, 5% | Experimental | AN2690 Topical Solution, 5% |
|
| Solution Vehicle | Placebo Comparator | Solution Vehicle |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AN2690 Topical Solution, 5% | Drug | AN2690 Topical Solution, 5%, applied once daily for 48 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Week 52 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| PfizerCT.gov Call Center | Pfizer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Investigational Site | Phoenix | Arizona | 85050 | United States | ||
| Investigational Site |
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.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | AN2690 Topical Solution, 5% | AN2690 Topical Solution, 5% AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks |
| FG001 | Solution Vehicle | Solution Vehicle Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Solution Vehicle | Drug | 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 | 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. | Week 52 |
| Negative Mycology of Target Great Toenail at Week 52 | Negative KOH and negative fungal culture. | Week 52 |
| Novato |
| California |
| 94945 |
| United States |
| Investigational Site | Oceanside | California | 92056 | United States |
| Investigational Site | San Diego | California | 92123 | United States |
| Investigational Site | San Francisco | California | 94115 | United States |
| Investigational Site | Santa Rosa | California | 95405 | United States |
| Investigational Site | Miami | Florida | 33144 | United States |
| Investigational Site | Miami | Florida | 33175 | United States |
| Investigational Site | Nampa | Idaho | 83642 | United States |
| Investigational Site | Evansville | Indiana | 47714 | United States |
| Investigational Site | Ann Arbor | Michigan | 48103 | United States |
| Investigational Site | St Louis | Missouri | 63117 | United States |
| Investigational Site | Verona | New Jersey | 07044 | United States |
| Investigational Site | Albuquerque | New Mexico | 87106 | United States |
| Investigational Site | High Point | North Carolina | 27262 | United States |
| Investigational Site | Raleigh | North Carolina | 27612 | United States |
| Investigational Site | Columbus | Ohio | 43212 | United States |
| Investigational Site | Portland | Oregon | 97223 | United States |
| Investigational Site | Philadelphia | Pennsylvania | 19103 | United States |
| Investigational Site | Greer | South Carolina | 29651 | United States |
| Investigational Site | Knoxville | Tennessee | 37922 | United States |
| Investigational Site | Dallas | Texas | 75243 | United States |
| Investigational Site | San Antonio | Texas | 78209 | United States |
| Investigational Site | Salt Lake City | Utah | 84124 | United States |
| Investigational Site | Harrisonburg | Virginia | 22801 | United States |
| Investigational Site | Norfolk | Virginia | 23507 | United States |
| Investigational Site | Barrie | Ontario | L4M6L2 | Canada |
| Investigational Site | Markham | Ontario | L3P1A8 | Canada |
| Investigational Site | North Bay | Ontario | P1B3Z7 | Canada |
| Investigational Site | Boucherville | Quebec | J4B5E4 | Canada |
| Investigational Site | Montreal | Quebec | H2K4L5 | Canada |
| Investigational Site | Québec | G1V4X7 | Canada |
| COMPLETED |
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| NOT COMPLETED |
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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.
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| ID | Title | Description |
|---|---|---|
| BG000 | AN2690 Topical Solution, 5% | AN2690 Topical Solution, 5% AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks |
| BG001 | Solution Vehicle | Solution Vehicle Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
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| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||
| Region of Enrollment | Number | participants |
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| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 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. | Posted | Number | participants | Week 52 |
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| Secondary | 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. | Efficacy analysis was performed using the ITT population. The LOCF was used in order to provide a value for efficacy parameters that were missing. | Posted | Number | participants | Week 52 |
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| Secondary | 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. | Efficacy analysis was performed using the ITT population. The LOCF was used in order to provide a value for efficacy parameters that were missing. | Posted | Number | participants | Week 52 |
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| Secondary | Negative Mycology of Target Great Toenail at Week 52 | Negative KOH and negative fungal culture. | Efficacy analysis was performed using the ITT population. The LOCF was used in order to provide a value for efficacy parameters that were missing. | Posted | Number | participants | Week 52 |
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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.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | AN2690 Topical Solution, 5% | AN2690 Topical Solution, 5% AN2690 Topical Solution, 5%: AN2690 Topical Solution, 5%, applied once daily for 48 weeks | 7 | 395 | 88 | 395 | ||
| EG001 | Solution Vehicle | Solution Vehicle Solution Vehicle: AN2690 Topical Solution, Vehicle, applied once daily for 48 weeks | 2 | 202 | 48 | 202 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Retinal artery occlusion (unrelated) | Eye disorders | MeDRA 13.1 | Systematic Assessment |
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| Appendicitis (unrelated) | Infections and infestations | MeDRA 13.1 | Systematic Assessment |
| |
| Bronchitis (unrelated) | Infections and infestations | MeDRA 13.1 | Systematic Assessment |
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| Cystitis (unrelated) | Infections and infestations | MeDRA 13.1 | Systematic Assessment |
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| Femur fracture (unrelated) | Injury, poisoning and procedural complications | MeDRA 13.1 | Systematic Assessment |
| |
| Arthralgia (unrelated) | Musculoskeletal and connective tissue disorders | MeDRA 13.1 | Systematic Assessment |
| |
| Carotid artery disease (unrelated) | Nervous system disorders | MeDRA 13.1 | Systematic Assessment |
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| Cerebrovascular accident (unrelated) | Nervous system disorders | MeDRA 13.1 | Systematic Assessment |
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| Transient ischaemic attack (unrelated) | Nervous system disorders | MeDRA 13.1 | Systematic Assessment |
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| Anxiety (unrelated) | Psychiatric disorders | MeDRA 13.1 | Systematic Assessment |
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| Pulmonary embolism (unrelated) | Respiratory, thoracic and mediastinal disorders | MeDRA 13.1 | Systematic Assessment |
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| Aortic aneurysm (unrelated) | Vascular disorders | MeDRA 13.1 | Systematic Assessment |
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| Deep vein thrombosis (unrelated) | Vascular disorders | MeDRA 13.1 | Systematic Assessment |
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| Peripheral artery aneurysm (unrelated) | Vascular disorders | MeDRA 13.1 | Systematic Assessment |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Tinea pedis | Infections and infestations | MeDRA 13.1 | Systematic Assessment |
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| Nasopharyngitis | Infections and infestations | MeDRA 13.1 | Systematic Assessment |
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| Upper respiratory tract infection | Infections and infestations | MeDRA 13.1 | Systematic Assessment |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Pfizer ClinicalTrials.gov Call Center | Pfizer, Inc. | 1-800-718-1021 | ClinicalTrials.gov_Inquiries@Pfizer.com |
| ID | Term |
|---|---|
| D014009 | Onychomycosis |
| D053546 | Keratoderma, Palmoplantar, Epidermolytic |
| D005533 | Foot Dermatoses |
| D054039 | Onycholysis |
| D056684 | Yellow Nail Syndrome |
| D009264 | Nails, Malformed |
| C562907 | Twenty-Nail Dystrophy |
| ID | Term |
|---|---|
| D014005 | Tinea |
| D003881 | Dermatomycoses |
| D009181 | Mycoses |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D012874 | Skin Diseases, Infectious |
| D009260 | Nail Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D015776 | Keratoderma, Palmoplantar, Diffuse |
| D007645 | Keratoderma, Palmoplantar |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D007642 | Keratosis |
| D005534 | Foot Diseases |
| D010859 | Pigmentation Disorders |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D012996 | Solutions |
| ID | Term |
|---|---|
| D004364 | Pharmaceutical Preparations |
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| Male |
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| Not Hispanic or Latino |
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| Unknown or Not Reported |
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| Asian |
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| Native Hawaiian or Other Pacific Islander |
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| Black or African American |
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| White |
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| More than one race |
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| Unknown or Not Reported |
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| Canada |
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