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

A Phase II, Multicentre, Double-blind, Placebo Controlled, Pilot Study to Evaluate the Safety and Efficacy of CUV1647 (Afamelanotide) as Adjunctive Therapy in Patients Undergoing Photodynamic Therapy (PDT) Utilising Porfimer Sodium

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.

Study Overview

• Status: Completed
• Conditions: Patients Undergoing Photodynamic Therapy Using Porfimer Sodium
• Intervention / Treatment: Drug: Placebo; Drug: Afamelanotide

• Study Type: Interventional
• Enrollment (Actual): 16
• Phase: Phase 2

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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.	Drug: Afamelanotide
Placebo Comparator: 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.	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
The First Day on Which Patients Are Free From Symptoms of Phototoxicity Following Phototesting	From Day 04 to Day 90

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Quality of Life	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.	From Day 0 to Day 20, Day 60 and Day 90

Collaborators and Investigators

• Sponsor: Clinuvel Pharmaceuticals Limited

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2008
• Primary Completion (Actual): May 28, 2009
• Study Completion (Actual): May 28, 2009

Study Registration Dates

• First Submitted: June 8, 2020
• First Submitted That Met QC Criteria: June 8, 2020
• First Posted (Actual): June 11, 2020

Study Record Updates

• Last Update Posted (Actual): October 1, 2021
• Last Update Submitted That Met QC Criteria: September 7, 2021
• Last Verified: September 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Dermatologic Agents; Afamelanotide
• Other Study ID Numbers: CUV025