Afamelanotide in Patients Suffering From Polymorphic Light Eruption (PLE)

What Was Tested

The trial (phase 3) is built around Melanotan I.

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

Afamelanotide implants were administered on Days 0 and 60. Patients returned to the clinic on Day 120 for the final visit.

Placebo implants were administered on Days 0 and 60. Patients returned to the clinic on Day 120 for the final visit.

The registry classes the interventions as drug.

Who Took Part

31 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: Aged greater than 18 years. Male or female patients with a documented history of PLE diagnosed or confirmed by a photodermatologist or photobiologist, with a history of PLE related pruritus symptoms. Written informed consent prior to the performance of any study-specific procedure. Are willing and able to comply with the conditions specified in the protocol and study procedures in the opinion of the Investigator.

The full record lists 5 inclusion and 12 exclusion criteria; among the exclusions: currently requiring treatment with systemic immunosuppressive agents; documented history of other photosensitivity conditions which may be confused with ple or interfere with the assessment of ple episodes; solarium use in the three months prior to study involvement and throughout the duration of the study.

How the Study Was Run

Design: randomized, parallel-group and quadruple-blind.

Random assignment meant chance, not the researchers, decided who got Melanotan I and who got the comparison, which limits bias.

Groups ran in parallel: each of the participants stayed in one arm throughout.

Blinding on both sides kept the participants and researchers unaware of who received Melanotan I.

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

It started in 2010-05-05 with completion listed for 2010-12-09.

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Severity of PLE Related Pruritus Recorded Using an 11-point Likert Scale (time frame: From Day 0 to Day 120).

It also tracked 3 secondary outcomes, for example Frequency (Number) of Documented PLE Episodes Recorded in Paper Patient Diaries, Duration of PLE Episodes Recorded in Paper Patient Diaries and Quality of Life Using the Dermatology Life Quality Index (DLQI).

What This Means in Plain Language

Put simply, this is a phase 3, randomized trial of Melanotan I in 31 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.