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

Running, not enrolling · Phase 3

Conditions studied: Vitiligo

In brief

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.

Key facts

Study ID

NCT06109649

Run by

Clinuvel, Inc.

People needed

200

Starts

2023-10-11

Expected to finish

2026-06-01

Last updated by the study team

2025-07-08

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male and female patients with a confirmed diagnosis of generalized vitiligo with VASI≥3 of the body and VASI on the head and neck ≥0.3 including an F-VASI≥0.1
• Stable or active vitiligo
• Aged 12 or more
• Fitzpatrick skin types III-VI

You may not qualify if…

• Fitzpatrick skin types I-II
• Extensive leukotrichia
• Treatment with NB-UVB phototherapy in the last three months prior to study start
• Allergy to afamelanotide or the polymer contained in the implant
• Any other treatment for vitiligo within 30 days prior to the Screening Visit
• History of melanoma or lentigo maligna
• History of dysplastic nevus syndrome
• Any malignant skin lesions
• Presence of severe hepatic disease or hepatic impairment
• Female who is pregnant or lactating
• Female of child-bearing potential not using adequate contraceptive measures
• Sexually active man with a partner of child-bearing potential who is not using adequate contraceptive measures
• Use of any prior and concomitant therapy which may interfere with the objective of the study
• Extensive tattoos

Where it is running

• 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

Full record on ClinicalTrials.gov

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