The CUV104 study will assess the efficacy and safety of afamelanotide in patients with vitiligo on the face and body as a monotherapy in repigmentation.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
6
Patients will receive afamelanotide over a three-month period, with an additional three-month follow up.
CLINUVEL Investigational site
Detroit, Michigan, United States
RECRUITINGProportion of participants achieving Vitiligo Area Scoring Index (VASI)25 on facial lesions
Measured using Vitiligo Area Scoring Index (VASI). A decrease in VASI indicates a reduction of the facial surface area affected by vitiligo (possible range 1-100)
Time frame: From Baseline to Day 84
Proportion of participants achieving Vitiligo Area Scoring Index (VASI)25 on body surface area
Proportion of participants achieving VASI25 on body surface area (excluding hands and feet). A decrease in VASI indicates a reduction of the facial surface area affected by vitiligo (possible range 1-100).
Time frame: From Baseline to Day 84
Percentage change in pigmentation on body surface area measured by the VASI scoring system
Percentage change in pigmentation on body surface area (excluding hands and feet) measured by VASI scoring system. A decrease in VASI indicates a reduction of the body surface area affected by vitiligo (possible range 1-100)
Time frame: From Baseline to Day 84
Percentage change in pigmentation on facial surface area measured by the VASI scoring system
A decreased VASI indicates a reduction in the faces' degree of depigmentation (possible range 1-100)
Time frame: From Baseline to Day 168
Change in Perception of Vitiligo Severity using a vitiligo validated specific tool (A)
The higher the score, the more severe the disease
Time frame: From Baseline to Day 168
Change in Noticeability of Vitiligo using a vitiligo validated specific tool (B)
Higher the value means lower noticeability
Time frame: From Baseline to Day 168
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Change in Quality of life using a vitiligo specific tool (C)
Higher value means a lower quality of life
Time frame: From Baseline to Day 168