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| Name | Class |
|---|---|
| TKL Research, Inc. | INDUSTRY |
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This study is designed to follow up patients who have achieved complete clearance of AK lesions at the Day 57 visit having completed the PEP005-016 or PEP005-025 studies over a 12 month period to assess both recurrence of Actinic Keratosis (AK) lesions and long term safety in the selected treatment area.
A 12 month long-term follow-up study of patients who have achieved complete clearance of AK lesions at the Day 57 in the Phase 3 studies PEP005-016 or PEP005-025.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Lesion count | Drug | Lesion count in area treated by study drug in a prior study. No drug will be applied during this long-term follow up study. Drug was applied during the primary study. |
| Measure | Description | Time Frame |
|---|---|---|
| Summarize treatment area recurrence of AK lesions, in the selected treatment area | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Summarize long-term safety data(incidence of AEs in the treatment area) | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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All patients must have achieved complete clearance of AK lesions at Day 57 visit in either study PEP005-016 or PEP005-025 will be offered participation in this study.
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| Name | Affiliation | Role |
|---|---|---|
| Eugene Bauer, MD | Chief Medical Officer | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Burke Pharmaceutical Research | Hot Springs | Arizona | 71913 | United States | ||
| Center for Dermatology |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 23553119 | Derived | Lebwohl M, Shumack S, Stein Gold L, Melgaard A, Larsson T, Tyring SK. Long-term follow-up study of ingenol mebutate gel for the treatment of actinic keratoses. JAMA Dermatol. 2013 Jun;149(6):666-70. doi: 10.1001/jamadermatol.2013.2766. |
| Label | URL |
|---|---|
| Food and Drug Authority | View source |
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|
| Fremont |
| California |
| 94538 |
| United States |
| Dermatology Research Associates | Los Angeles | California | 90045 | United States |
| Dermatology Specialists Inc | Oceanside | California | 92056 | United States |
| Skin Surgery Medical Group Inc. | San Diego | California | 92117 | United States |
| Conant Medical Group | San Francisco | California | 94114 | United States |
| North Florida Dermatology Associates, PA | Jacksonville | Florida | 32204 | United States |
| University of Miami, Skin Research Camp | Miami | Florida | 33136 | United States |
| Atlanta Dermatology, Vein & Research Center, LLC | Alpharetta | Georgia | 30022 | United States |
| Medaphase Inc | Newnan | Georgia | 30263 | United States |
| Altman Dermatology Associates | Arlington Heights | Illinois | 60005 | United States |
| Glazer Dermatology | Buffalo Grove | Illinois | 60089 | United States |
| Laser Skin Surgery Center of Indiana | Carmel | Indiana | 46032 | United States |
| Deaconess Clinic, Inc | Evansville | Indiana | 47713 | United States |
| Dawes Fretein Clinical Research Group, LLC | Indianapolis | Indiana | 46256 | United States |
| The Indiana Clinical Trials Center, PC | Plainfield | Indiana | 46168 | United States |
| Pedia Research LLC | Owensboro | Kentucky | 42301 | United States |
| Hamzavi Dermatology | Fort Gratiot | Michigan | 48059 | United States |
| Minnesota Clinical Study Center | Fridley | Minnesota | 55432 | United States |
| Skin Specialists, PC | Omaha | Nebraska | 68144 | United States |
| Karl G. Heine Dermatology | Henderson | Nevada | 89002 | United States |
| Academic Dermatology Associates | Albuquerque | New Mexico | 87106 | United States |
| Mount Sinai School of Medicine | New York | New York | 10029-6574 | United States |
| Dermatology Associates of Rochester, PC | Rochester | New York | 14623 | United States |
| Dermatology, Laser Vein Specialists of the Carolinas | Charlotte | North Carolina | 28207 | United States |
| Wake Research Associates | Raleigh | North Carolina | 27612 | United States |
| Oregon Medical Research | Portland | Oregon | 97223 | United States |
| Dermatology Research Associates | Nashville | Tennessee | 37203 | United States |
| DermResearch, Inc. | Austin | Texas | 78759 | United States |
| J & S Studies, Inc. | College Station | Texas | 77845 | United States |
| Suzanne Bruce and Associates, The Center for Skin Research | Houston | Texas | 77056 | United States |
| Progressive Clinical Research | San Antonio | Texas | 78229 | United States |
| Dermatology Associates of Tyler | Tyler | Texas | 75703 | United States |
| Center for Clinical Studies | Webster | Texas | 77598 | United States |
| Dermatology Research Center, Inc. | Salt Lake City | Utah | 84124 | United States |
| The Education and Research Foundation | Lynchburg | Virginia | 24501 | United States |
| Virginia Clinical Research, Inc | Norfolk | Virginia | 23507 | United States |
| Premier Clinical Research | Spokane | Washington | 99204 | United States |
| Southderm Pty Ltd | Kogarah | New South Wales | 2217 | Australia |
| St George Dematology and Skin Cancer Centre | Kogarah | New South Wales | 2217 | Australia |
| The Skin Centre | Benowa | Queensland | 4217 | Australia |
| South East Dermatology, Belmont Specialist Centre | Carina Heights | Queensland | 4152 | Australia |
| Therapeutic Goods Administration | View source |
| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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