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This study is designed to follow up patients, who have achieved complete clearance of AK lesions (lesion count of 0) at Day 57 in the PEP005-020 study, over a 12 month period to assess both recurrence of Actinic Keratosis (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 over a 12 month period 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 adverse events in the treatment area) | 12 months |
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Patients who have achieved complete clearance of AK lesions (lesion count of 0) at Day 57 in study PEP005-020
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Park Avenue Dermatology | Orange Park | Florida | 32073 | United States | ||
| Medaphase 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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| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
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|
| Newnan |
| Georgia |
| 30263 |
| United States |
| Gwinnett Clinical Research Centre | Snellville | Georgia | 30078-3250 | United States |
| Michigan Center for Research Corp | Clinton Twp | Michigan | 48038 | United States |
| Henry Ford Health Systems | Detroit | Michigan | 48202 | United States |
| Dermatology Associates of Rochester | Rochester | New York | 14623 | United States |
| Oregon Health and Science University | Portland | Oregon | 97239-4501 | United States |
| Dermatology Research Associates | Nashville | Tennessee | 37203 | United States |
| Dematology on Ward | Adelaide | South Australia | 5006 | Australia |
| Dermatology Institute of Victoria | Melbourne | Victoria | 3141 | Australia |
| St John of God Dermatology | Subiaco | Western Australia | 6008 | Australia |
| Therapeutic Goods Administration | View source |
| D017437 |
| Skin and Connective Tissue Diseases |