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The main purpose of this trial is to demonstrate the predictive value of the clinical diagnosis of clearance of Actinic Keratoses after treatment with Ingenol Mebutate using histopathological examination as the standard.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Open label active | Other |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ingenol mebutate gel 0.05% | Drug | Once daily for 2 consecutive days |
|
| Measure | Description | Time Frame |
|---|---|---|
| Clearance of AK | The primary response criterion is the clinical and histological clearance of AK at Day 57. Clinical Clearance will be measured by counting AKs, and histological clearance will be by performing a biopsy (result reported as AK or not AK). | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Complete clearance of AKs in the Selected Treatment Area | Efficacy in terms of complete clearance of AKs in the STA and histological clearance of pre-identified lesion. AK clearance will be determined by AK count. Clearance of the pre-identified lesion will be assessed by a histopatholgist from a biopsy sample and reported as AK or not AK. | 8 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Martina Ulrich | Collegium Medicum Berlin GmbH, Germany | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southderm Pty Ltd | Kogarah | New South Wales | 2217 | Australia | ||
| Melanoma Institute Australia |
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| Label | URL |
|---|---|
| LEO Pharma | View source |
| Therapeutic Goods Administration | View source |
| Clinical Trials at LEO Pharma |
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| North Sydney |
| New South Wales |
| 2060 |
| Australia |
| The Skin Centre | Benowa | Queensland | 4217 | Australia |
| South East Dermatology Centre | Carina Heights | Queensland | 4152 | Australia |
| St John of God Dermatology | Subiaco | Western Australia | 6008 | Australia |
| Burswood Dermatology | Victoria Park | Western Australia | 6100 | Australia |
| Klinik für Dermatologie & Allergologie Klinikum Augsburg Süd | Augsburg | 86179 | Germany |
| Collegium Medicum Berlin GmbH | Berlin | 10117 | Germany |
| Medizinisches Zentrum Bonn Friedensplatz | Bonn | 42275 | Germany |
| Hautarztpraxis Prof. Dr. med. C. Termeer | Stuttgart | 70499 | Germany |
| 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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