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

What Was Tested

The trial (phase 2) is built around Melanotan I.

It had two arms (groups): Afamelanotide (experimental) and Placebo (placebo comparator).

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.

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.

The registry classes the interventions as drug.

Who Took Part

Enrollment: 16 actual participants took part.

It was open to people of any sex aged from 18 years with no upper age limit.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 3 inclusion and 9 exclusion criteria; among the exclusions: known allergy or hypersensitivity to afamelanotide or the polymer contained in the implant;; non-caucasian patients;; personal history of melanoma or dysplastic nevus syndrome;.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Because people in this Melanotan I study were split into groups at random, differences between the groups are less likely to reflect who happened to join each one.

The Melanotan I group and the comparison group ran side by side rather than switching.

As a double-blind Melanotan I study, the assignments were hidden from both participants and investigators until the end.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2008-08-05 with completion listed for 2009-05-28.

Its stated primary purpose is treatment.

What Was Measured

The main thing measured (primary outcome): The First Day on Which Patients Are Free From Symptoms of Phototoxicity Following Phototesting (time frame: From Day 04 to Day 90).

It also tracked 1 secondary outcome, for example Change in Quality of Life.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Melanotan I in 16 people.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; results are posted on the registry, and this page does not restate them.

More context: the Melanotan I compound page, all human trials.