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

Clinuvel (UK) Ltd.10 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

Purpose

PREVENTION

Masking

NONE

Enrollment

Conditions

Afamelanotide Evaluated as Skin DNA Repair Therapy in Healthy Volunteers

Interventions

AfamelanotideDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

CLINUVEL Investigational Site

Clinuvel Investigational Site, United Kingdom

Outcomes

Primary Outcomes

Change in UV photoproduct levels in UVR-exposed skin.

Analysis of UV photoproducts from skin samples.

Time frame: 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.

Time frame: From Baseline to Day 28.

Secondary Outcomes

Change in UV-induced DNA damage and repair markers.

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

Time frame: 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.

Time frame: From Baseline to Day 28

Change in UVR-erythema dose-response.

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

Time frame: From Baseline to Day 28

Data from ClinicalTrials.gov

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