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The purpose of this study is to evaluate the safety and efficacy of topical application of IDP-108 versus vehicle in treating patients with onychomycosis.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IDP-108 | Experimental |
| |
| Vehicle | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| IDP-108 | Drug | Topical application once a day for 48 weeks |
| |
| Vehicle |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients who achieve clinical cure | 52 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of patients who achieve clinical efficacy | 52 weeks | |
| Percentage of patients who achieve mycologic cure | 52 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama, Birmingham | Birmingham | Alabama | 35233 | United States | ||
| HOPE Research Institute |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25007364 | Derived | Gupta AK, Elewski BE, Sugarman JL, Ieda C, Kawabata H, Kang R, Pillai R, Olin JT, Watanabe S. The efficacy and safety of efinaconazole 10% solution for treatment of mild to moderate onychomycosis: a pooled analysis of two phase 3 randomized trials. J Drugs Dermatol. 2014 Jul;13(7):815-20. |
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| Drug |
Topical application once a day for 48 weeks |
|
| Phoenix |
| Arizona |
| 85050 |
| United States |
| Therapeutics Clinical Research | San Diego | California | 92123 | United States |
| University Clinical Trials, Inc | San Diego | California | 92123 | United States |
| University of California, San Francisco | San Francisco | California | 94115 | United States |
| Longmont Medical Research Network | Longmont | Colorado | 80501 | United States |
| The Savin Center, PC | New Haven | Connecticut | 06511 | United States |
| Foot and Ankle Associates of Florida, Inc | Altamonte Springs | Florida | 32701 | United States |
| International Dermatology Research, Inc. | Miami | Florida | 33144 | United States |
| Ameriderm Research | Ormond Beach | Florida | 32174 | United States |
| Augusta Centre for Dermatology and Skin Renewal, LLC | Augusta | Georgia | 30909 | United States |
| Gwinnett Clinical Research Center, Inc. | Snellville | Georgia | 30078 | United States |
| Northwest Clinical Trials | Boise | Idaho | 83704 | United States |
| Hudson Dermatology | Evansville | Indiana | 47714 | United States |
| Dermatology Specialists | Louisville | Kentucky | 40202 | United States |
| Michigan Center for Research Corp. | Clinton Township | Michigan | 48038 | United States |
| Academic Dermatology | Albuquerque | New Mexico | 87106 | United States |
| Impact Clinical Trials | New Hyde Park | New York | 11040 | United States |
| Radiant Research | Cinncinati | Ohio | 45249 | United States |
| Haber Dermatology & Cosmetic Surgery | South Euclid | Ohio | 44118 | United States |
| Oregon Dermatology and Research Center | Portland | Oregon | 97219 | United States |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | United States |
| Temple University School of Podiatric Medicine | Philadelphia | Pennsylvania | 19107 | United States |
| Palmetto Clinical Trial Services, LLC | Greenville | South Carolina | 29607 | United States |
| Rivergate Dermatology | Goodlettsville | Tennessee | 37072 | United States |
| Austin Dermatology Associates | Austin | Texas | 78705 | United States |
| J & S Studies, Inc. | College Station | Texas | 77845 | United States |
| Baylor Research Institute | Dallas | Texas | 75246 | United States |
| Stephen Miller, MD, PA | San Antonio | Texas | 78229 | United States |
| Dermatology Resarch Center | Salt Lake City | Utah | 84124 | United States |
| The Education and Research Foundation, Inc. | Lynchburg | Virginia | 24501 | United States |
| Virginia Clinical Research, Inc | Norfolk | Virginia | 23507 | United States |
| Aurora Advanced Healthcare, Inc. - Clinical Research Center | Milwaukee | Wisconsin | 53209 | United States |
| Kirk Barber Research | Calgary | Alberta | T2S 3B3 | Canada |
| Stratica Medical | Edmonton | Alberta | T5K 1X3 | Canada |
| Ultranova Skincare | Barrie | Ontario | L4M 6L2 | Canada |
| Mediprobe Research | New London | Ontario | N5X 2P1 | Canada |
| North Bay Dermatology Centre | North Bay | Ontario | P1B 3Z7 | Canada |
| XLR8 Medical Research | Windsor | Ontario | N8W 1E6 | Canada |
| Centre de Recherche Dermatologique du Québec Métropolitain | Québec | Quebec | G1V 4X7 | Canada |
| Kaken Investigational Site | Dazaifu | Fukuoka | Japan |
| Kaken Investigational Site - Chuo-ku #1 | Fukuoka | Fukuoka | Japan |
| Kaken Investigational Site - Chuo-ku #2 | Fukuoka | Fukuoka | Japan |
| Kaken Investigational Site - Higashi-ku | Fukuoka | Fukuoka | Japan |
| Kaken Investigational Site - Minami-ku #1 | Fukuoka | Fukuoka | Japan |
| Kaken Investigational Site - Minami-ku #2 | Fukuoka | Fukuoka | Japan |
| Kaken Investigational Site | Itoshima | Fukuoka | Japan |
| Kaken Investigational Site - Atsubetsu-ku #1 | Sapporo | Hokkaido | Japan |
| Kaken Investigational Site - Atsubetsu-ku #2 | Sapporo | Hokkaido | Japan |
| Kaken Investigational Site - Atsubetsu-ku #3 | Sapporo | Hokkaido | Japan |
| Kaken Investigational Site - Chuo-ku | Sapporo | Hokkaido | Japan |
| Kaken Investigational Site - Kita-ku | Sapporo | Hokkaido | Japan |
| Kaken Investigational Site - Kiyota-ku | Sapporo | Hokkaido | Japan |
| Kaken Investigational Site - Nishi-ku | Sapporo | Hokkaido | Japan |
| Kaken Investigational Site - Shiroishi-ku | Sapporo | Hokkaido | Japan |
| Kaken Investigational Site - Teine-ku #1 | Sapporo | Hokkaido | Japan |
| Kaken Investigational Site - Teine-ku #2 | Sapporo | Hokkaido | Japan |
| Kaken Investigational Site | Kawasaki | Kanagawa | Japan |
| Kaken Investigational Site | Nagasaki | Nagasaki | Japan |
| Kaken Investigational Site | Ginowan | Okinawa | Japan |
| Kaken Investigational Site | Naha | Okinawa | Japan |
| Kaken Investigational Site | Nakagami | Okinawa | Japan |
| Kaken Investigational Site - Okinawa #1 | Okinawa | Okinawa | Japan |
| Kaken Investigational Site - Okinawa #2 | Okinawa | Okinawa | Japan |
| Kaken Investigational Site | Urasoe | Okinawa | Japan |
| Kaken Investigational Site | Kawaguchi | Saitama | Japan |
| Kaken Investigational Site - Nakano-ku #1 | Nakano-ku | Tokyo | Japan |
| Kaken Investigational Site - Nakano-ku #2 | Nakano-ku | Tokyo | Japan |
| Kaken Investigational Site - Setagaya-ku #1 | Setagaya-ku | Tokyo | Japan |
| Kaken Investigational Site - Setagaya-ku #2 | Setagaya-ku | Tokyo | Japan |
| Kaken Investigational Site - Shinagawa-ku #1 | Shinagawa-ku | Tokyo | Japan |
| Kaken Investigational Site - Shinagawa-ku #2 | Shinagawa-ku | Tokyo | Japan |
| 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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