ACTIVE_NOT_RECRUITING

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

Conditions

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

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

Quick Facts

Study Start:2023-10-11
Study Completion:2026-06
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06109649

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.

Ages Eligible for Study:12 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * 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
  2. * Stable or active vitiligo
  3. * Aged 12 or more
  4. * Fitzpatrick skin types III-VI
  1. * Fitzpatrick skin types I-II
  2. * Extensive leukotrichia
  3. * Treatment with NB-UVB phototherapy in the last three months prior to study start
  4. * Allergy to afamelanotide or the polymer contained in the implant
  5. * Any other treatment for vitiligo within 30 days prior to the Screening Visit
  6. * History of melanoma or lentigo maligna
  7. * History of dysplastic nevus syndrome
  8. * Any malignant skin lesions
  9. * Presence of severe hepatic disease or hepatic impairment
  10. * Female who is pregnant or lactating
  11. * Female of child-bearing potential not using adequate contraceptive measures
  12. * Sexually active man with a partner of child-bearing potential who is not using adequate contraceptive measures
  13. * Use of any prior and concomitant therapy which may interfere with the objective of the study
  14. * Extensive tattoos

Contacts and Locations

Study Locations (Sites)

CLINUVEL site
Birmingham, Alabama, 00000
United States
CLINUVEL site
Fresno, California, 00000
United States
CLINUVEL site
Los Angeles, California, 00000
United States
CLINUVEL site
Palo Alto, California, 00000
United States
CLINUVEL site
San Diego, California, 00000
United States
CLINUVEL Site
Washington, D.C., District of Columbia, 00000
United States
CLINUVEL site
Miami, Florida, 00000
United States
CLINUVEL site
Miramar, Florida, 00000
United States
CLINUVEL site
Alpharetta, Georgia, 00000
United States
CLINUVEL site
Augusta, Georgia, 00000
United States
CLINUVEL site
Chicago, Illinois, 00000
United States
CLINUVEL site
Baton Rouge, Louisiana, 00000
United States
CLINUVEL site
Detroit, Michigan, 00000
United States
CLINUVEL site
Minneapolis, Minnesota, 00000
United States
CLINUVEL site
Roseville, Minnesota, 00000
United States
CLINUVEL Site
Lee's Summit, Missouri, 00000
United States
CLINUVEL site
Rochester, New York, 00000
United States
CLINUVEL site
Cleveland, Ohio, 00000
United States
CLINUVEL site
Philadelphia, Pennsylvania, 00000
United States
CLINUVEL Site
Charleston, South Carolina, 00000
United States
CLINUVEL site
Thompson's Station, Tennessee, 00000
United States
CLINUVEL Site
Cedar Park, Texas, 00000
United States
CLINUVEL site
Dallas, Texas, 00000
United States
CLINUVEL site
Tyler, Texas, 00000
United States
CLINUVEL site
Charlottesville, Virginia, 00000
United States

Collaborators and Investigators

Sponsor: Clinuvel, Inc.

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2023-10-11
Study Completion Date2026-06

Study Record Updates

Study Start Date2023-10-11
Study Completion Date2026-06

Terms related to this study

Additional Relevant MeSH Terms

  • Vitiligo