Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE2
200 participants
INTERVENTIONAL
2007-11-30
2012-08-31
Brief Summary
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The number of lesions formed on the head, hands and forarms will be monitored over this 24 month test period.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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1
Afamelanotide (CUV1647) implant administered subcutaneously every 60 days for 24 months
Afamelanotide (CUV1647)
16 mg subcutaneous implant administered every 60 days
2
Placebo implant administered subcutaneously every 60 days for 24 months
Placebo
Placebo subcutaneous implant administered every 60 days
Interventions
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Afamelanotide (CUV1647)
16 mg subcutaneous implant administered every 60 days
Placebo
Placebo subcutaneous implant administered every 60 days
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Clinuvel Pharmaceuticals Limited
INDUSTRY
Responsible Party
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Clinuvel Pharmaceuticals
Principal Investigators
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Günther Hofbauer, M.D.
Role: PRINCIPAL_INVESTIGATOR
Universitätsspital Zürich
Locations
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The Princess Alexandra Hospital
Brisbane, Queensland, Australia
The Queen Elizabeth Hospital
Adelaide, South Australia, 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
Countries
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Other Identifiers
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CUV011
Identifier Type: -
Identifier Source: org_study_id