A Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Xeroderma Pigmentosum C and V

What Was Tested

In this phase 2 trial, researchers set out to test Melanotan I.

The CUV152 study will evaluate the safety of afamelanotide in XP-C and XP-V patients, as well as the drug's ability to assist reparative processes following ultraviolet (UV) provoked DNA damage of the skin.

It had 1 arm (groups): Afamelanotide (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 6 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: Male or female patient with a molecular-genetically confirmed diagnosis of XP-C or XP-V;. Aged 18-75 years.

The full record lists 2 inclusion and 10 exclusion criteria; among the exclusions: known allergy to afamelanotide or the polymer contained in the implant;; presence of severe hepatic disease or hepatic impairment;; renal impairment;.

How the Study Was Run

The set-up was single-group and open-label.

Being open-label, the Melanotan I study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2022-03-28 with completion listed for 2024-06.

It ran at 2 sites in Belgium (1) and Spain (1).

Its stated primary purpose is treatment.

What Was Measured

Primary outcome: Change in MED in patients with XP-V (time frame: From baseline to day 76).

It also tracked 14 secondary outcomes, for example Changes in UV-induced DNA damage, as assessed by quantification of UV photoproduct levels in patients with XP-C, Changes in UV-induced DNA damage repair capacity, as assessed by quantification of DNA repair mechanisms in patients with XP-C, Changes in UV-induced DNA damage, as assessed by quantification of UV photoproduct levels in patients with XP-V, Changes in UV-induced DNA damage repair capacity, as assessed by quantification of DNA repair mechanisms in patients with XP-V, Change in skin disease severity in patients with XP-C (A) and Change in skin disease severity in patients with XP-V (A).

What This Means in Plain Language

Put simply, this is a phase 2 trial of Melanotan I in 6 people.

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

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.