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A Study to Compare the Efficacy and Safety of SCENESSE and Narrow-Band Ultraviolet (NB-UVB) Light Versus NB-UVB Light Alone in Patients With Vitiligo
Sponsor: Clinuvel, Inc.
Summary
The CUV105 study will assess the efficacy and safety of afamelanotide and NB-UVB light in patients with vitiligo on the body and face versus NB-UVB light alone.
Official title: A Double-Arm, Open Label, Phase III Study to Compare the Efficacy and Safety of SCENESSE and Narrow-Band Ultraviolet B (NB-UVB) Light Versus NB-UVB Light Alone in the Treatment of Vitiligo
Key Details
Gender
All
Age Range
12 Years - Any
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2023-10-11
Completion Date
2026-06
Last Updated
2025-07-08
Healthy Volunteers
No
Conditions
Interventions
Afamelanotide and NB-UVB Light
Patients will receive combination of NB-UVB twice weekly and afamelanotide every 3 weeks for 20 weeks.
NB-UVB Light
Patients will receive NB-UVB light twice per week for 20 weeks. Upon study completion, NB-UVB Light Arm participants will have the opportunity to enroll in an open-label extension phase of the study. In this extension phase, participants will undergo the same evaluations and assessments as the ones performed in the main part of the study under Afamelanotide and NB-UVB Light Arm.
Locations (30)
CLINUVEL site
Birmingham, Alabama, United States
CLINUVEL site
Fresno, California, United States
CLINUVEL site
Los Angeles, California, United States
CLINUVEL site
Palo Alto, California, United States
CLINUVEL site
San Diego, California, United States
CLINUVEL Site
Washington D.C., District of Columbia, United States
CLINUVEL site
Miami, Florida, United States
CLINUVEL site
Miramar, Florida, United States
CLINUVEL site
Alpharetta, Georgia, United States
CLINUVEL site
Augusta, Georgia, United States
CLINUVEL site
Chicago, Illinois, United States
CLINUVEL site
Baton Rouge, Louisiana, United States
CLINUVEL site
Detroit, Michigan, United States
CLINUVEL site
Minneapolis, Minnesota, United States
CLINUVEL site
Roseville, Minnesota, United States
CLINUVEL Site
Lee's Summit, Missouri, United States
CLINUVEL site
Rochester, New York, United States
CLINUVEL site
Cleveland, Ohio, United States
CLINUVEL site
Philadelphia, Pennsylvania, United States
CLINUVEL Site
Charleston, South Carolina, United States
CLINUVEL site
Thompson's Station, Tennessee, United States
CLINUVEL Site
Cedar Park, Texas, United States
CLINUVEL site
Dallas, Texas, United States
CLINUVEL site
Tyler, Texas, United States
CLINUVEL site
Charlottesville, Virginia, United States
CLINUVEL site
La Réunion, France
CLINUVEL site
Nice, France
CLINUVEL site
Nairobi, Kenya
CLINUVEL site
London, United Kingdom
CLINUVEL site
Manchester, United Kingdom