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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Afamelanotide | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Afamelanotide | 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. |
| 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. |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CLINUVEL Investigational Site | Clinuvel Investigational Site | United Kingdom |
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| ID | Term |
|---|---|
| C534526 | afamelanotide |
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| 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 |