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

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.

Study Overview

• Status: Completed
• Conditions: Afamelanotide Evaluated as Skin DNA Repair Therapy in Healthy Volunteers
• Intervention / Treatment: Drug: Afamelanotide

• Study Type: Interventional
• Enrollment (Actual): 10
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • Clinuvel Investigational Site, United Kingdom
    • CLINUVEL investigational site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Afamelanotide	Drug: Afamelanotide; 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 is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in UV photoproduct levels in UVR-exposed skin.	Analysis of UV photoproducts from skin samples.	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.	From Baseline to Day 28.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in UV-induced DNA damage and repair markers.	Analysis of UV photoproducts and DNA repair mechanisms from skin samples.	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.	From Baseline to Day 28
Change in UVR-erythema dose-response.	UVR erythema dose response measured with a non-invasive quantitative skin reflectance measurement.	From Baseline to Day 28

Collaborators and Investigators

• Sponsor: Clinuvel (UK) Ltd.

Study record dates

Study Major Dates

• Study Start (ACTUAL): January 19, 2022
• Primary Completion (ACTUAL): February 1, 2023
• Study Completion (ACTUAL): February 1, 2023

Study Registration Dates

• First Submitted: April 21, 2022
• First Submitted That Met QC Criteria: May 6, 2022
• First Posted (ACTUAL): May 10, 2022

Study Record Updates

• Last Update Posted (ESTIMATE): February 9, 2023
• Last Update Submitted That Met QC Criteria: February 8, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Dermatologic Agents; Afamelanotide
• Other Study ID Numbers: CUV151

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: Yes