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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
200
16 mg subcutaneous implant administered every 60 days
Placebo subcutaneous implant administered every 60 days
The Princess Alexandra Hospital
Brisbane, Queensland, Australia
The Queen Elizabeth Hospital
Adelaide, South Australia, Australia
The Royal Melbourne Hospital
Melbourne, Victoria, Australia
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
Time frame: 24 months
To determine and compare the proportion of patients in each group that develops one or more squamous cell carcinoma (SCC)
Time frame: 24 months
To examine the effect of ongoing sun exposure on lesion formation and progression in the patient group
Time frame: 24 months
To evaluate the safety and tolerability of multiple slow release subcutaneous implants of afamelanotide (CUV1647)
Time frame: 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
...and 2 more locations