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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Afamelanotide Evaluated as Skin DNA Repair Therapy in Healthy Volunteers

Intervention / Treatment
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* Drug: Afamelanotide


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 45 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Afamelanotide<br> | Drug: Afamelanotide<br>* 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.<br>|

What is the study measuring?
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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 |