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The purpose of this study is to assess the safety and effectiveness of two concentrations of IDP-108 in treating patients with onychomycosis
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental |
| |
| 2 | Experimental |
| |
| 3 | Experimental |
| |
| 4 | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low Strength IDP-108 | Drug | Topical application once a day for 9 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in area of infected nail | 9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in mycological results | 9 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Unidad de Investigación en Salud | Chihuahua City | Chihuahua | CP31205 | Mexico | ||
| Clinical Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23377392 | Derived | Tschen EH, Bucko AD, Oizumi N, Kawabata H, Olin JT, Pillai R. Efinaconazole solution in the treatment of toenail onychomycosis: a phase 2, multicenter, randomized, double-blind study. J Drugs Dermatol. 2013 Feb;12(2):186-92. |
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| High Strength IDP-108 |
| Drug |
Topical application once a day for 9 months |
|
| High Strength IDP-108 under occlusion | Drug | Topical application once a day for 9 months |
|
| Vehicle | Drug | Topical application once a day for 9 months |
|
| Mexico City |
| Federal District |
| CP54055 |
| Mexico |
| Hospital Central Militar | Mexico City | Federal District | Mexico |
| Hospital General de México | México | Federal District | CP 06726 | Mexico |
| Instituto Dermatólogico de Jalisco "Dr. Jose Barba Rubio" | Guadalajara | Jalisco | CP45190 | Mexico |
| Hospital Dr. Ángel Leaño | Zapopan | Jalisco | CP45200 | Mexico |
| MIRC/OCA Hospital | Monterrey | Nuevo León | CP64000 | Mexico |
| Centro de Dermatología de Monterrey | Monterrey | Nuevo León | CP64460 | Mexico |
| Hospital Universitario "José E. González" | Monterrey | Nuevo León | CP64460 | Mexico |
| Hospital Ignacio Morones Prieto SLP | San Luis Potosí City | San Luis Potosí | CP 78240 | Mexico |
| 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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