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

Description

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.

Conditions

Vitiligo

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Vitiligo
Intervention / Treatment

-

Contacts and Locations

Los Angeles

CLINUVEL site, Los Angeles, California, United States, 00000

Miami

CLINUVEL site, Miami, Florida, United States, 00000

Miramar

CLINUVEL site, Miramar, Florida, United States, 00000

Baton Rouge

CLINUVEL site, Baton Rouge, Louisiana, United States, 00000

Detroit

CLINUVEL site, Detroit, Michigan, United States, 00000

Roseville

CLINUVEL site, Roseville, Minnesota, United States, 00000

Lee's Summit

CLINUVEL Site, Lee's Summit, Missouri, United States, 00000

Charleston

CLINUVEL Site, Charleston, South Carolina, United States, 00000

Thompson's Station

CLINUVEL site, Thompson's Station, Tennessee, United States, 00000

Cedar Park

CLINUVEL Site, Cedar Park, Texas, United States, 00000

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Male and female patients with a confirmed diagnosis of generalized vitiligo with VASI≥0.3 of the body and F-VASI≥0.3
  • * Stable or active vitiligo
  • * Aged 12 or more
  • * Fitzpatrick skin types IV-VI
  • * Fitzpatrick skin types I-III
  • * 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 four weeks 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

Ages Eligible for Study

12 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Clinuvel, Inc.,

Study Record Dates

2025-06