Actinic Keratoses, Carcinoma, Squamous Cell, Organ Transplant Recipients
Conditions
Keywords
Actinic keratoses (AK), Squamous cell carcinomas (SCC), CUV1647, Afamelanotide, Clinuvel, Photoprotection, Organ transplant
Brief summary
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.
Interventions
16 mg subcutaneous implant administered every 60 days
DRUGPlacebo
Placebo subcutaneous implant administered every 60 days
Sponsors
Clinuvel Pharmaceuticals Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
* Organ transplant recipients with stable transplant function and who received their transplant at least 2 years prior to study entry * Organ transplant patients who have had at least one biopsy-positive SCC * Aged 18 - 75 years * Written informed consent to the performance of all study-specific procedures
Exclusion criteria
* Allergy to afamelanotide (CUV1647) or the polymer contained in the implant * History of melanoma * Current pigmentary disorders such as melasma * Diagnosed with HIV/AIDS, or hepatitis B or C * Current history of drug or alcohol abuse (in the last 12 months) * Clinically significant organ dysfunction, history of medical disorders or other factors, which in the opinion of the investigator will interfere with the interpretation of study outcome measures * Major medical or psychiatric illness * Pregnancy as confirmed by positive serum beta-HCG pregnancy test prior to baseline or lactating mothers * Females of child bearing potential not using adequate contraceptive measures * Participation in a clinical trial for an investigational agent within 30 days prior to the screening visit * Use of regular medications or any other factors that may affect skin pigmentation Discontinuation Criteria: * Initiation of treatment with systemic retinoids * Change of class of systemic immunosuppressant treatment
Design outcomes
Primary
| Measure | 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 |
Secondary
| Measure | 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 |
| To evaluate the safety and tolerability of multiple slow release subcutaneous implants of afamelanotide (CUV1647) | 24 months |
Countries
Australia, Belgium, France, Germany, Italy, Sweden, Switzerland
Outcome results
None listed