Phase II AK Study in Organ Transplant Patients

What Was Tested

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

The number of lesions formed on the head, hands and forarms will be monitored over this 24 month test period.

It had two arms (groups): 1 (experimental) and 2 (placebo comparator).

Afamelanotide (CUV1647) implant administered subcutaneously every 60 days for 24 months.

Placebo implant administered subcutaneously every 60 days for 24 months.

The registry classes the interventions as drug.

Who Took Part

200 planned participants were the target.

It was open to people of any sex aged from 18 years up to 75 years.

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

Examples of who could join: Organ transplant recipients with stable transplant function and who received their transplant at least 2 years prior to study entry. Organ transplant patients who have had at least one biopsy-positive SCC. Aged 18 - 75 years. Written informed consent to the performance of all study-specific procedures.

The full record lists 4 inclusion and 13 exclusion criteria; among the exclusions: allergy to afamelanotide (cuv1647) or the polymer contained in the implant; history of melanoma; current pigmentary disorders such as melasma.

How the Study Was Run

Design: randomized, parallel-group and double-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.

Neither the participants nor the staff measuring them knew who was on Melanotan I, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant and investigator.

It started in 2007-11 with completion listed for 2012-07.

It ran at 12 sites in Australia (3), Belgium (2), Germany (2), Italy (2), France (1) and Sweden (1).

Its stated primary purpose is prevention.

What Was Measured

The main thing measured (primary outcome): To determine the effect of afamelanotide (CUV1647) administered from slow release subcutaneous implants on the number of actinic keratoses (AKs) on the head, forearms and back of hands (time frame: 24 months).

It also tracked 3 secondary outcomes, for example To determine and compare the proportion of patients in each group that develops one or more squamous cell carcinoma (SCC), To examine the effect of ongoing sun exposure on lesion formation and progression in the patient group and To evaluate the safety and tolerability of multiple slow release subcutaneous implants of afamelanotide (CUV1647).

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Melanotan I in 200 people.

Its status is unknown; no results are posted to the registry yet, so nothing here describes outcomes.

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