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

A Mechanistic Study to Evaluate Impact of Subcutaneous Implants of Afamelanotide on Ultraviolet Radiation-induced DNA Damage and DNA Repair Capacity in Healthy Volunteers With Skin Types I-III

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05368857

Enrollment

Registered

2022-05-10

Start date

2022-01-19

Completion date

2023-02-01

Last updated

2023-02-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Afamelanotide Evaluated as Skin DNA Repair Therapy in Healthy Volunteers

Brief 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.

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.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

PREVENTION

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 45 Years

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

* 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.

Design outcomes

Primary

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

Secondary

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

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026