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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Patients will receive afamelanotide every two weeks for twelve weeks and undergo a follow up visit 6 months later.
CLINUVEL Investigational site
Clinuvel Investigational Site, Belgium
RECRUITINGCLINUVEL Investigational site
Clinuvel Investigational Site, Spain
RECRUITINGChange in minimal erythema dose (MED) in patients with XP-C.
MED is the lowest dose of UV light that causes reddening of the skin.
Time frame: 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.
Time frame: From baseline to day 76.
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.
Time frame: 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.
Analysis of DNA repair mechanisms from skin samples.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From baseline to day 76.
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Change in skin disease severity in patients with XP-V (A)
The higher the score, the more severe the disease.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From baseline to day 76.