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The purpose of this study is to determine whether afamelanotide (CUV1647) is effective in reducing the number of actinic keratoses and squamous cell carcinomas developing in immune compromised organ transplant recipients, who are at particularly high risk, over a 24 month test period.
The number of lesions formed on the head, hands and forarms will be monitored over this 24 month test period.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 1 | Experimental | Afamelanotide (CUV1647) implant administered subcutaneously every 60 days for 24 months |
|
| 2 | Placebo Comparator | Placebo implant administered subcutaneously every 60 days for 24 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Afamelanotide (CUV1647) | Drug | 16 mg subcutaneous implant administered every 60 days |
| |
| Measure | Description | Time Frame |
|---|---|---|
| To determine the effect of afamelanotide (CUV1647) administered from slow release subcutaneous implants on the number of actinic keratoses (AKs) on the head, forearms and back of hands | 24 months |
| Measure | Description | Time Frame |
|---|---|---|
| To determine and compare the proportion of patients in each group that develops one or more squamous cell carcinoma (SCC) | 24 months | |
| To examine the effect of ongoing sun exposure on lesion formation and progression in the patient group | 24 months |
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Inclusion Criteria:
Exclusion Criteria:
Discontinuation Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Günther Hofbauer, M.D. | Universitätsspital Zürich | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Princess Alexandra Hospital | Brisbane | Queensland | 4102 | Australia | ||
| The Queen Elizabeth Hospital |
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| ID | Term |
|---|---|
| D055623 | Keratosis, Actinic |
| D002294 | Carcinoma, Squamous Cell |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D007642 | Keratosis |
| D012871 | Skin Diseases |
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| ID | Term |
|---|---|
| C534526 | afamelanotide |
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| Placebo |
| Drug |
Placebo subcutaneous implant administered every 60 days |
|
| To evaluate the safety and tolerability of multiple slow release subcutaneous implants of afamelanotide (CUV1647) | 24 months |
| Adelaide |
| South Australia |
| 5011 |
| Australia |
| The Royal Melbourne Hospital | Melbourne | Victoria | Australia |
| Hospital Erasme | Brussels | Belgium |
| Gent University Hospital | Ghent | Belgium |
| University Hospital | Besançon | France |
| Charité Univeritätsklinikum | Berlin | Germany |
| Kiel University Hospital | Kiel | Germany |
| Ospedali Riuniti di Bergamo | Bergamo | Italy |
| University of Padua | Padua | Italy |
| Karolinska University Hospital | Stockholm | Sweden |
| Universitätsspital Zürich | Zurich | Switzerland |
| D017437 |
| Skin and Connective Tissue Diseases |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D018307 | Neoplasms, Squamous Cell |