Status:
COMPLETED
Afamelanotide as Adjunctive Therapy in Patients Undergoing Photodynamic Therapy (PDT) Utilising Porfimer Sodium
Lead Sponsor:
Clinuvel Pharmaceuticals Limited
Conditions:
Patients Undergoing Photodynamic Therapy Using Porfimer Sodium
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The purpose of this study was to evaluate the safety and efficacy of afamelanotide (previously developed as CUV1647) as adjunctive therapy in patients undergoing photodynamic therapy using porfimer so...
Eligibility Criteria
Inclusion
- Male or female Caucasian subjects undergoing photodynamic therapy with porfimer sodium;
- Aged greater than 18 years;
- Written informed consent prior to the performance of any study-specific procedure.
Exclusion
- Known allergy or hypersensitivity to afamelanotide or the polymer contained in the implant;
- Non-Caucasian patients;
- Personal history of melanoma or dysplastic nevus syndrome;
- Current Bowen's disease, basal cell carcinoma, squamous cell carcinoma, or other malignant or premalignant skin lesions;
- Female who is pregnant (confirmed by positive serum β-HCG pregnancy test prior to baseline) or lactating;
- Females of child-bearing potential (pre-menopausal, not surgically sterile) not using adequate contraceptive measures (i.e. oral contraceptives, diaphragm plus spermicide, intrauterine device);
- Participation in a simultaneous clinical trial for another investigational agent or within 30 days prior to the screening visit;
- Patients unable to give informed consent;
- Patient needs for concomitant medication with potential photosensitizing effects e.g. antibiotics like tetracyclines.
Key Trial Info
Start Date :
August 5 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 28 2009
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04425746
Start Date
August 5 2008
End Date
May 28 2009
Last Update
October 1 2021
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