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OpenTrials
Completed

NCT Number: NCT05368857

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

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.

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Key information

Conditions

Afamelanotide Evaluated as Skin DNA Repair Therapy in Healthy Volunteers

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

CLINUVEL Investigational Site

Clinuvel Investigational Site, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Afamelanotide

Drug

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.

Primary outcomes

  1. Change in UV photoproduct levels in UVR-exposed skin.

    Time frame: From Baseline to Day 28

    Analysis of UV photoproducts from skin samples.

  2. Change in rate of UV photoproduct repair in UVR-exposed skin.

    Time frame: From Baseline to Day 28.

    Analysis of UV photoproduct repair mechanisms from skin samples.

Secondary outcomes

  1. Change in UV-induced DNA damage and repair markers.

    Time frame: From Baseline to Day 28

    Analysis of UV photoproducts and DNA repair mechanisms from skin samples.

  2. Change in Minimal Erythema Dose (MED).

    Time frame: From Baseline to Day 28

    Minimal erythema dose (MED) is the lowest dose of UV light that causes reddening of the skin.

  3. Change in UVR-erythema dose-response.

    Time frame: From Baseline to Day 28

    UVR erythema dose response measured with a non-invasive quantitative skin reflectance measurement.

Sponsors and collaborators

Lead sponsor

Clinuvel (UK) Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
May 10, 2022
Registry last updated
Feb 9, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.