Afamelanotide as Adjunctive Therapy in Patients Undergoing Photodynamic Therapy (PDT) Utilising Porfimer Sodium

Phase 2

Completed

• Conditions: Patients Undergoing Photodynamic Therapy Using Porfimer Sodium
• Interventions: Drug: Afamelanotide; Drug: Placebo

• Registration Number: NCT04425746
• Lead Sponsor: Clinuvel Pharmaceuticals Limited

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 sodium.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-08-05
• Primary Completion: 2009-05-28
• Study Completion: 2009-05-28
• Study First Submitted: 2020-06-08
• Study First Submitted QC: 2020-06-08
• Study First Posted: 2020-06-11
• Results First Submitted: 2021-06-17
• Status Verified: 2021-09
• Results First Submitted QC: 2021-09-07
• Last Update Submitted: 2021-09-07
• Results First Posted: 2021-10-01
• Last Update Posted: 2021-10-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 16

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.

Read More

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.

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Afamelanotide	Afamelanotide	Subjects visited the clinic on Day 0 (administration of afamelanotide implant and porfimer sodium), Day 2 (photodynamic therapy), and Days 20 and 90 for assessments of adverse events, concomitant medication and the results of evaluation of phototoxicity.
Placebo	Placebo	Subjects visited the clinic on Day 0 (administration of placebo implant and porfimer sodium), Day 2 (photodynamic therapy), and Days 20 and 90 for assessments of adverse events, concomitant medication and the results of evaluation of phototoxicity.

Primary Outcome Measures

Name	Time	Method
The First Day on Which Patients Are Free From Symptoms of Phototoxicity Following Phototesting	From Day 04 to Day 90

Secondary Outcome Measures

Name	Time	Method
Change in Quality of Life	From Day 0 to Day 20, Day 60 and Day 90	Quality of life, as measured by the Short Form-36 Health survey (SF-36) (quality of life questionnaire). The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability.