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

Phase 1

Completed

• Conditions: Afamelanotide Evaluated as Skin DNA Repair Therapy in Healthy Volunteers
• Interventions: Drug: Afamelanotide

• Registration Number: NCT05368857
• Lead Sponsor: Clinuvel (UK) Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-19
• Study First Submitted: 2022-04-21
• Study First Submitted QC: 2022-05-06
• Study First Posted: 2022-05-10
• Status Verified: 2023-02
• Primary Completion: 2023-02-01
• Study Completion: 2023-02-01
• Last Update Submitted: 2023-02-08
• Last Update Posted: 2023-02-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Afamelanotide	Afamelanotide	-

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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.

Trial Locations

Locations (1)

CLINUVEL Investigational Site; 🇬🇧 Clinuvel Investigational Site, United Kingdom