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The CUV152 study will evaluate the safety of afamelanotide in XP-C and XP-V patients, as well as the drug's ability to assist reparative processes following ultraviolet (UV) provoked DNA damage of the skin. It will assess whether SCENESSE® increases the amount of UV light needed to cause DNA damage of skin cells, as well as the extent of skin repair before and after treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Afamelanotide | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Afamelanotide | Drug | Patients will receive afamelanotide every two weeks for twelve weeks and undergo a follow up visit 6 months later. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in minimal erythema dose (MED) in patients with XP-C. | MED is the lowest dose of UV light that causes reddening of the skin. | From baseline to day 76. |
| Change in MED in patients with XP-V. | MED is the lowest dose of UV light that causes reddening of the skin. | From baseline to day 76. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in UV-induced DNA damage, as assessed by quantification of UV photoproduct levels in patients with XP-C. | Analysis of UV photoproducts from skin samples. | From baseline to day 76. |
| Changes in UV-induced DNA damage repair capacity, as assessed by quantification of DNA repair mechanisms in patients with XP-C. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Head of Clinical Operations | Contact | +441372860765 | mail@clinuvel.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CLINUVEL Investigational site | Recruiting | Clinuvel Investigational Site | Belgium |
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| ID | Term |
|---|---|
| D014983 | Xeroderma Pigmentosum |
| ID | Term |
|---|---|
| D011230 | Precancerous Conditions |
| D009369 | Neoplasms |
| D012868 | Skin Abnormalities |
| D000013 | Congenital Abnormalities |
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| ID | Term |
|---|---|
| C534526 | afamelanotide |
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Analysis of DNA repair mechanisms from skin samples. |
| From baseline to day 76. |
| Changes in UV-induced DNA damage, as assessed by quantification of UV photoproduct levels in patients with XP-V. | Analysis of UV photoproducts from skin samples. | From baseline to day 76. |
| Changes in UV-induced DNA damage repair capacity, as assessed by quantification of DNA repair mechanisms in patients with XP-V. | Analysis of DNA repair mechanisms from skin samples. | From baseline to day 76. |
| Change in skin disease severity in patients with XP-C (A). | The higher the score, the more severe the disease. | From baseline to day 76. |
| Change in skin disease severity in patients with XP-V (A) | The higher the score, the more severe the disease. | From baseline to day 76. |
| Change in skin disease severity in patients with XP-C (B). | The higher the score, the more severe the disease. | From baseline to day 76. |
| Change in skin disease severity in patients with XP-V (B). | The higher the score, the more severe the disease. | From baseline to day 76. |
| Change in skin disease severity in patients with XP-C (C). | The higher the score, the more severe the disease. | From baseline to day 76. |
| Change in skin disease severity in patients with XP-V (C). | The higher the score, the more severe the disease. | From baseline to day 76. |
| Change in quality of life assessed by a disease specific tool (A) in patients with XP-C. | Higher scores represent worse health-related quality of life. | From baseline to day 76. |
| Change in quality of life assessed by a disease specific tool (A) in patients with XP-V. | Higher scores represent worse health-related quality of life. | From baseline to day 76. |
| Change in quality of life assessed by a validated global quality of life tool (B) in patients with XP-C. | Score calculated in impairment percentages, with higher numbers indicating greater impaired quality of life. | From baseline to day 76. |
| Change in quality of life assessed by a validated global quality of life tool (B) in patients with XP-V. | Score calculated in impairment percentages, with higher numbers indicating greater impaired quality of life. | From baseline to day 76. |
| CLINUVEL Investigational site | Recruiting | Clinuvel Investigational Site | Spain |
|
| D009358 |
| Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D010787 | Photosensitivity Disorders |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D010859 | Pigmentation Disorders |
| D049914 | DNA Repair-Deficiency Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |