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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

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

NCT06109649•Clinuvel, Inc.

View on ClinicalTrials.gov

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.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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

Exclusion Criteria

•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
+4 more criteria

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

Key Dates

Start Date

October 11, 2023

Primary Completion Date

December 1, 2025

Completion Date

June 1, 2026

Last Updated

July 8, 2025

Enrollment

200

ESTIMATED participants

Conditions

Vitiligo

Interventions

Afamelanotide and NB-UVB Light

DRUG

NB-UVB Light

PROCEDURE

A Phase IIb Dose-ranging Study to Assess the Efficacy and Safety of GIA632 in Participants With Non-segmental Vitiligo

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RECRUITINGPHASE4

The Value of Methotrexate in NCES for Stable Vitiligo

NCT07352293

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RECRUITINGPHASE2

Melanotan II (MT-II) as an Adjunct to NB-UVB Phototherapy for Repigmentation in Stable Nonsegmental Vitiligo

NCT07437560

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 8, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions

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

Inclusion Criteria

Exclusion Criteria

A Phase IIb Dose-ranging Study to Assess the Efficacy and Safety of GIA632 in Participants With Non-segmental Vitiligo

The Value of Methotrexate in NCES for Stable Vitiligo

Melanotan II (MT-II) as an Adjunct to NB-UVB Phototherapy for Repigmentation in Stable Nonsegmental Vitiligo

Effectiveness of Micro-needling With 5 Fluorouracil Versus Potent Topical Steroids in the Treatment of Limited Vitiligo

A Proof of Concept, Phase 1 Study of CGB-600 for the Topical Treatment of Non-Segmented Facial Vitiligo

Betamethasone Phonophoresis For Vitiligo