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This study is designed to follow up patients, who have participated in the PEP005-028 study and observed complete clearance of their Actinic Keratosis (AK) lesions, over a 12 month period to assess both recurrence of AK lesions and long term safety in the selected treatment area.
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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 during a 12 month follow-up period for patients with complete clearance, who have completed Day 57 in Study PEP005-028. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Summarize long-term safety data, in the selected treatment area over a 12 month follow-up period for patients with complete clearance, who have completed Day 57 in Study PEP005-028. | 12 months |
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Inclusion
Exclusion
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Patients who achieved complete clearance of AK lesions at the Day 57 visit in the PEP005-028 study
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Burke Pharmaceutical Research | Hot Springs | Arizona | 71913 | United States | ||
| Skin Surgery Medical Group Inc. |
| 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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|
| San Diego |
| California |
| 92117 |
| United States |
| Atlanta Dermatology, Vein & Research Center, LLC | Alpharetta | Georgia | 30022 | United States |
| Altman Dermatology Associates | Arlington Heights | Illinois | 60005 | United States |
| Glazer Dermatology | Buffalo Grove | Illinois | 60089 | United States |
| Deaconess Clinic Downtown | Evansville | Indiana | 47713 | United States |
| Dawes Fretzin Clinical Research Group, LLC | Indianapolis | Indiana | 46256 | United States |
| Skin Specialists, PC | Omaha | Nebraska | 68144 | United States |
| Karl G. Heine Dermatology | Henderson | Nevada | 89002 | United States |
| Group Health Associates | Cincinnati | Ohio | 45220 | United States |
| DermResearch, Inc. | Austin | Texas | 78759 | United States |
| Suzanne Bruce and Associates, PA, The Center for Skin Research | Houston | Texas | 77056 | United States |
| Dermatology Clinical Research Center of San Antonio | San Antonio | Texas | 78229 | United States |
| Dermatology Associates of Tyler | Tyler | Texas | 75703 | United States |
| Dermatology Research Centre | 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 |
| 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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