Phase 2
N=16
Afamelanotide as Adjunctive Therapy in Patients Undergoing Photodynamic Therapy (PDT) Utilising Porfimer Sodium
Patients Undergoing Photodynamic Therapy Using Porfimer Sodium
Bottom Line
View on ClinicalTrials.gov: NCT04425746 ↗Enrolled (actual)
16
Serious AEs
31.3%
Results posted
Oct 2021
Primary outcome: Primary: The First Day on Which Patients Are Free From Symptoms of Phototoxicity Following Phototesting
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Afamelanotide (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Clinuvel Pharmaceuticals Limited
- Primary completion
- May 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY The First Day on Which Patients Are Free From Symptoms of Phototoxicity Following Phototesting |
— | — |
| SECONDARY Change in Quality of Life |
-5.7; 8.0; -14.6; 0.0; -1.4; -11.6 | — |
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 sodium.
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- 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.
Data sourced from ClinicalTrials.gov (NCT04425746). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.