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

Overview

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.

Full Title of Study: “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”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
  • Study Primary Completion Date: May 28, 2009

Interventions

  • Drug: Afamelanotide
  • Drug: Placebo

Arms, Groups and Cohorts

  • 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.
  • 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.

Clinical Trial Outcome Measures

Primary Measures

  • The first day on which patients are free from phototoxicity symptoms following phototesting
    • Time Frame: From Day 04 to Day 90

Secondary Measures

  • Changes in quality of life
    • Time Frame: Day 0, 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.

Participating in This Clinical Trial

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.

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Clinuvel Pharmaceuticals Limited
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Pilar Bilbao, Study Director, Clinuvel Pharmaceuticals Limited

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