CompletedNCT05368857Updated Feb 9, 2023

DNA Repair Capacity of Afamelanotide on Ultraviolet Radiation-induced DNA Damage in Healthy Volunteers

A Phase 1 interventional study of Afamelanotide in Afamelanotide Evaluated as Skin DNA Repair Therapy in Healthy Volunteers, sponsored by Clinuvel (UK) Ltd.. Completed at 1 site in United Kingdom. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-02-09.

Sponsored by Clinuvel (UK) Ltd. · Phase 1, Interventional, and Prevention

From the registry’s dates

Primary completion was Feb 2023, 3 years 8 months ago, and no results have been posted to the registry.
Registered 3 months after the study started (first participant enrolled Jan 2022, registered Apr 2022).

Phase: Phase 1
Study type: Interventional
Enrollment: 10
Allocation: Not applicable
Ages: 18 Years to 45 Years
Sex: All

Study summary

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.

Conditions studied

Afamelanotide Evaluated as Skin DNA Repair Therapy in Healthy Volunteers

In context

Lead sponsor

This is the only study on the registry with Clinuvel (UK) Ltd. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years to 45 Years
Sexes eligible: All
Accepts healthy volunteers: Yes

Inclusion criteria

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.

Exclusion criteria

Exclusion Criteria:

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.
Any significant illness during the four weeks before the study screening period.
Taking known photosensitisers.

Study design

Phase: Phase 1
Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrollment: 10 participants (actual)

Study arms

Experimental
Afamelanotide
Drug: Afamelanotide

Interventions

DrugAfamelanotide
Up to 10 adult healthy volunteers will be enrolled in this study in which small areas of their skin will be exposed to UVR and skin samples taken. UV-induced DNA damage and repair will be analysed.

What researchers measure

Primary outcomes

Change in UV photoproduct levels in UVR-exposed skin.
Analysis of UV photoproducts from skin samples.
Time frame: From Baseline to Day 28
Change in rate of UV photoproduct repair in UVR-exposed skin.
Analysis of UV photoproduct repair mechanisms from skin samples.
Time frame: From Baseline to Day 28.

Secondary outcomes

Change in UV-induced DNA damage and repair markers.
Analysis of UV photoproducts and DNA repair mechanisms from skin samples.
Time frame: From Baseline to Day 28
Change in Minimal Erythema Dose (MED).
Minimal erythema dose (MED) is the lowest dose of UV light that causes reddening of the skin.
Time frame: From Baseline to Day 28
Change in UVR-erythema dose-response.
UVR erythema dose response measured with a non-invasive quantitative skin reflectance measurement.
Time frame: From Baseline to Day 28

Study locations

1 site

CLINUVEL Investigational Site
Clinuvel Investigational Site, United Kingdom

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Feb 9, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT05368857
Lead sponsor: Clinuvel (UK) Ltd.
Responsible party: Sponsor
First posted: May 10, 2022
Start date: Jan 19, 2022
Primary completion: Feb 1, 2023
Completion: Feb 1, 2023
Last update: Feb 9, 2023

Oversight

FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2023. You cannot join it, but the record below documents what was studied.

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Discussion

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