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

C

Clinuvel

Status and phase

Completed
Phase 2

Conditions

Patients Undergoing Photodynamic Therapy Using Porfimer Sodium

Treatments

Drug: Placebo
Drug: Afamelanotide

Study type

Interventional

Funder types

Industry

Identifiers

NCT04425746
CUV025

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Quadruple Blind

16 participants in 2 patient groups, including a placebo group

Afamelanotide
Experimental group
Description:
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.
Treatment:
Drug: Afamelanotide
Placebo
Placebo Comparator group
Description:
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.
Treatment:
Drug: Placebo

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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