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DNA Repair Capacity of Afamelanotide on Ultraviolet Radiation-induced DNA Damage in Healthy Volunteers
Plain-language guide to NCT05368857: phase 1 interventional trial of Melanotan I, 10 participants. Who took part, design and what was measured.
Key Facts
- Registry ID
- NCT05368857
- Phase
- phase 1
- Status
- completed
- Start
- 2022-01-19
- Completion (planned or actual)
- 2023-02-01
- Participants
- 10 (actual)
- Design
- na, open label (everyone knows who gets what), prevention
- Conditions studied
- Afamelanotide Evaluated as Skin DNA Repair Therapy in Healthy Volunteers
- Results posted
- not yet
What This Study Did, in Plain Language
What Was Tested
The trial (phase 1) is built around Melanotan I.
This mechanistic study's aim is to assess the DNA damage repair capabilities of afamelanotide in healthy volunteers with skin type I-III following exposure to ultraviolet radiation (UVR)-induced DNA damage.
It had 1 arm (groups): Afamelanotide (experimental).
The registry classes the interventions as drug.
Who Took Part
The registry lists 10 actual participants took part.
It was open to people of any sex aged from 18 years up to 45 years.
Healthy volunteers could join, not only people with the condition.
Examples of who could join: Healthy male or female volunteers (aged 18-45) with Fitzpatrick skin types I, II or III. Written informed consent obtained from volunteers prior to study-start.
The full record lists 2 inclusion and 5 exclusion criteria; among the exclusions: female who is pregnant or lactating; females of child-bearing potential not using adequate contraceptive measures or a lifestyle excluding pregnancy; sexually active man with a partner of child-bearing potential who is not using adequate contraceptive measures.
How the Study Was Run
It was run as a single-group and open-label study.
Everyone knew when Melanotan I was being given (open label), which is simpler to run but leaves more room for expectations to affect what is reported.
Everyone received the same intervention, so there was no separate comparison group inside the trial.
It started in 2022-01-19 with completion listed for 2023-02-01.
It ran at 1 site in United Kingdom.
Its stated primary purpose is prevention.
What Was Measured
Researchers chose this as the main measure: Change in UV photoproduct levels in UVR-exposed skin (time frame: From Baseline to Day 28). Change in rate of UV photoproduct repair in UVR-exposed skin (time frame: From Baseline to Day 28).
It also tracked 3 secondary outcomes, for example Change in UV-induced DNA damage and repair markers.
What This Means in Plain Language
Put simply, this is a phase 1 trial of Melanotan I in 10 people.
Its size is small, so on its own it can only give an early look.
The trial is marked completed; 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.