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

Patients Undergoing Photodynamic Therapy Using Porfimer Sodium Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04425746
• Other study ID #: CUV025
• Status: Completed
• Phase: Phase 2
• Start date: August 5, 2008
• Est. completion date: May 28, 2009

Study information

• Verified date: September 2021
• Source: Clinuvel Pharmaceuticals Limited
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 16
• Est. completion date: May 28, 2009
• Est. primary completion date: May 28, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ß-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.

Related Conditions & MeSH terms

• Patients Undergoing Photodynamic Therapy Using Porfimer Sodium

Intervention

Drug:
• Afamelanotide

• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Clinuvel Pharmaceuticals Limited

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The First Day on Which Patients Are Free From Symptoms of Phototoxicity Following Phototesting		From Day 04 to Day 90
Secondary	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