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A Study to Evaluate the Safety and Efficacy of Afamelanotide in Patients With Xeroderma Pigmentosum (XP)
Plain-language guide to NCT05159752: phase 2 interventional trial of Melanotan I, 6 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT05159752
- Phase
- phase 2
- Status
- status unknown
- Start
- 2021-10-19
- Completion (planned or actual)
- 2024-03
- Participants
- 6 (estimated)
- Design
- na, open label (everyone knows who gets what), treatment
- Conditions studied
- Xeroderma Pigmentosum
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
In this phase 2 trial, researchers set out to test Melanotan I.
The CUV156 study will evaluate the safety of afamelanotide in XP-C 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;. Aged 18-75 years.
The full record lists 2 inclusion and 9 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 2021-10-19 with completion listed for 2024-03.
It ran at 1 site in Germany.
Its stated primary purpose is treatment.
What Was Measured
It also tracked 7 secondary outcomes, for example Change in UV-induced DNA damage and repair capacity, Change in skin disease severity (A), Change in skin disease severity (B), Change in skin disease severity (C), Change in dermal melanin density and Change in quality of life assessed by a disease specific tool (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.
Our Notes on the Compound
Melanotan I: A synthetic melanotropin (α-MSH analog), afamelanotide, studied for pigmentation; the approved product is an implant.
Related Pages
Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.