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
NCT ID: NCT06109649
Last Updated: 2025-07-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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ACTIVE_NOT_RECRUITING
PHASE3
200 participants
INTERVENTIONAL
2023-10-11
2026-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Afamelanotide and NB-UVB Light
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
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* Stable or active vitiligo
* Aged 12 or more
* Fitzpatrick skin types III-VI
Exclusion Criteria
* 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
12 Years
ALL
No
Sponsors
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Clinuvel, Inc.
INDUSTRY
Responsible Party
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Locations
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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
Countries
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Other Identifiers
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CUV105
Identifier Type: -
Identifier Source: org_study_id
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