DNA repair capacity of afamelanotide in Healthy Volunteers v1
Research type
Research Study
Full 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
IRAS ID
291195
Contact name
Pilar Bilbao
Contact email
Sponsor organisation
CLINUVEL (UK) Ltd.
Duration of Study in the UK
0 years, 2 months, 23 days
Research summary
Ultraviolet radiation (UVR), from either sunlight or artificial sources such as tanning beds, can cause damage to skin cells, including sunburn and DNA damage. This damage activates mechanisms in the skin that protect cells (tanning response) and repair DNA damage. Afamelanotide is a laboratory produced chemical, very similar to the natural human hormone called alpha melanocyte stimulating hormone (α-MSH). Afamelanotide works in a similar way to the natural hormone by increasing skin melanisation (tanning). It is also anti-oxidative (reduces the formation of substances known as free radicals, which are harmful) and in a previous study it reduced the amount of skin cell DNA damage after UVR exposure. Afamelanotide is approved and used in the European Union and USA as a photoprotective agent in patients with the photosensitivity disorder erythropoietic protoporphyria. This study will evaluate how afamelanotide provides skin protection, specifically its effect on the amount of DNA damage and the repair response mechanisms following UVR exposure in healthy volunteers.
Main eligibility criteria: healthy adult males and females volunteers with Fitzpatrick skin types I, II or III aged between 18 and 45 years; able to understand and provide written Informed Consent; free of significant abnormal findings.
Ten (10) subjects will be enrolled in the study, their participation will last for four weeks and involves a total of nine visits to the Photobiology Unit (2 to 3 visits per week on consecutive days). The study involves the exposure of small areas of skin to a UVR lamp, and 8 skin samples (punch biopsies). Participants will receive one dose of afamelanotide 16 mg at Visit 4. This will be absorbed within 2-3 months.REC name
Wales REC 5
REC reference
20/WA/0315
Date of REC Opinion
25 Nov 2020
REC opinion
Favourable Opinion