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The purpose of the study is to determine the safety and efficacy of high and low strength of ME1111 solutions compared to the vehicle in the treatment of onychomycosis of the toenail.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ME1111 Solution, Low strength | Experimental |
| |
| ME1111 Solution, High strength | Experimental |
| |
| Matching Vehicle Solution | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ME1111 Solution, Low strength | Drug | ME1111 Solution, Low strength, applied once daily for 48 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Complete cure rate at Week 52 | complete cure :clear (zero %) clinical involvement of the target great toenail and mycologic cure. | Week 52 |
| Measure | Description | Time Frame |
|---|---|---|
| Complete or almost complete cure rate at Week 52 | complete or almost complete cure:5 % or less clinical involvement of the target great toenail and mycologic cure. | Week 52 |
| Number of Adverse events |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Meiji Study Director | Meiji Seika Pharma Co., Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Birmingham | Alabama | United States | ||||
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| ME1111 Solution, High strength | Drug | ME1111 Solution, High strength, applied once daily for 48 weeks |
|
| Matching Vehicle Solution | Drug | Matching Vehicle Solution, applied once daily for 48 weeks |
|
| Up to Week 48, Week 52, EOS |
| Local Tolerability Assessments | Local Tolerability Assessments:Burning/Stinging, Pruritus, Dryness, Scaling, Erythema, General Irritation, Induration/Edema, Oozing/crusting. | Up to Week 48, Week 52, EOS |
| Encinitas |
| California |
| United States |
| San Diego | California | United States |
| San Francisco | California | United States |
| Santa Rosa | California | United States |
| Denver | Colorado | United States |
| Miami | Florida | United States |
| Miramar | Florida | United States |
| Newnan | Georgia | United States |
| Boise | Idaho | United States |
| Evansville | Indiana | United States |
| Baltimore | Maryland | United States |
| Ann Arbor | Michigan | United States |
| Clinton Township | Michigan | United States |
| Fridley | Minnesota | United States |
| Albuquerque | New Mexico | United States |
| New York | New York | United States |
| Rochester | New York | United States |
| Cincinnati | Ohio | United States |
| Portland | Oregon | United States |
| Mt. Pleasant | South Carolina | United States |
| Knoxville | Tennessee | United States |
| Nashville | Tennessee | United States |
| Austin | Texas | United States |
| College Station | Texas | United States |
| Dallas | Texas | United States |
| San Antonio | Texas | United States |
| Salt Lake City | Utah | United States |
| Lynchburg | Virginia | United States |
| Norfolk | Virginia | United States |
| Spokane | Washington | United States |
| ID | Term |
|---|---|
| D014009 | Onychomycosis |
| 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 |
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