Completed

NCT Number: NCT04425746

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.

Completed

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Key information

Conditions

Patients Undergoing Photodynamic Therapy Using Porfimer Sodium

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Afamelanotide

Drug

Placebo

Drug

Primary outcomes

The First Day on Which Patients Are Free From Symptoms of Phototoxicity Following Phototesting

Time frame: From Day 04 to Day 90

Secondary outcomes

Change in Quality of Life

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Clinuvel Pharmaceuticals Limited

Industry

Registry information

Official study title

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

Important dates

Study start: 2008
Primary completion: 2009
Study completion: 2009
First posted: Jun 11, 2020
Registry last updated: Oct 1, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.