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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-19

Study Completion Date

2023-02-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

DNA Repair Activity in the Skin of Day and Night Shift Workers

NCT04122456

Skin Cancer

RECRUITING NA

Study of Intradermal Injections of RCS-01 in Male and Female Subjects

NCT02391935

Intrinsic Aging of Skin Skin Wrinkling Solar Degeneration of Skin

COMPLETED PHASE1

Randomised Controlled Trial of an Antioxidant and Sunscreen Combination Cream for Reducing DNA Damage in Human Skin

NCT07301515

Photoaging Photodamage Mitochondrial Damage +3 more

COMPLETED NA

Effect of Topical Sulforaphane on Skin Fragility Seen in Skin Aging and With Ultraviolet Exposure

NCT03126539

Aging

TERMINATED PHASE2

Optimizing Phototesting and Investigating Photobiology of Visible Light

NCT05964907

Healthy

ACTIVE_NOT_RECRUITING NA

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Afamelanotide Evaluated as Skin DNA Repair Therapy in Healthy Volunteers

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Afamelanotide

Group Type EXPERIMENTAL

Afamelanotide

Intervention Type 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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes