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This trial will be conducted to explore the biological effects in the skin following treatment with PEP005 Gel, 0.05% administered for two consecutive days, assessed by histology.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ingenol mebutate | Experimental | PEP gel 0.05% once daily exposure |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PEP005 (Ingenol mebutat Gel, 0.05 %) | Drug | All eligible patients will receive PEP005 Gel, 0.05 %, on two consecutive days to both the AK Treatment Area and the Normal Skin Treatment Area |
| Measure | Description | Time Frame |
|---|---|---|
| Leukocytes Infiltration and degree of necrosis of the AK lesion and skin | Degree of skin infiltration of leukocytes and necrosis of the epidermis and dermis in the AK biopsies from Day 1, Day 2, and Day 3 | From baseline until day 3 |
| Measure | Description | Time Frame |
|---|---|---|
| Biological effects in the skin |
Number of participants with changes in normal skin and AK lesion biopsies | from baseline till day day 3 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Michael P Schön, MD | Universitätsmedizin Göttingen, Georg-August-Universität | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universitätsmedizin Göttingen, Georg-August-Universität | Göttingen | D-37075 | Germany |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27612149 | Derived | Emmert S, Haenssle HA, Zibert JR, Schon M, Hald A, Hansen MH, Litman T, Schon MP. Tumor-Preferential Induction of Immune Responses and Epidermal Cell Death in Actinic Keratoses by Ingenol Mebutate. PLoS One. 2016 Sep 9;11(9):e0160096. doi: 10.1371/journal.pone.0160096. eCollection 2016. |
| Label | URL |
|---|---|
| Clinical Trials at LEO Pharma | 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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| ID | Term |
|---|---|
| C486592 | 3-ingenyl angelate |
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| D017437 |
| Skin and Connective Tissue Diseases |