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NCT06109649 · ClinicalTrials.gov registry record · Phase 3
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 Phase 3 study of Vitiligo, sponsored by Clinuvel.
- Active
- Registry status
- Phase 3
- Development phase
- 200
- Enrollment target
- 20
- Study locations
NCT06109649: Active Phase 3 study of Vitiligo, sponsored by Clinuvel.
NCT06109649 is a Phase 3 study of Vitiligo that is active but no longer recruiting, run by Clinuvel. The registered enrollment target is 200 participants, below the 1,111-participant average among 15 other Vitiligo trials with a reported enrollment target (82% lower). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06109649, a Phase 3 study of Vitiligo, is active but no longer recruiting, sponsored by Clinuvel.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 200 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
Measured using Vitiligo Area Scoring Index (VASI). A decrease in VASI indicates a reduction of the body surface area affected by vitiligo (possible range 1-100).
Conditions Studied
Interventions
- DRUG Afamelanotide and NB-UVB Light
- PROCEDURE NB-UVB Light
Study Locations (20)
California
- CLINUVEL site - Fresno
- CLINUVEL site - Los Angeles
- CLINUVEL site - Palo Alto
- CLINUVEL site - San Diego
Florida
- CLINUVEL site - Miami
- CLINUVEL site - Miramar
Georgia
- CLINUVEL site - Alpharetta
- CLINUVEL site - Augusta
Minnesota
- CLINUVEL site - Minneapolis
- CLINUVEL site - Roseville
Alabama
- CLINUVEL site - Birmingham
District of Columbia
- CLINUVEL Site - Washington D.C.
Illinois
- CLINUVEL site - Chicago
Louisiana
- CLINUVEL site - Baton Rouge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 200 participants |
| Start Date | 2023-10-11 |
| Est. Completion | 2026-06 |
| Phase | Phase 3 |
What the registry record for NCT06109649 still lists
NCT06109649 is an interventional study that assigns participants to a tested intervention. The registered 200 participants enrollment target is mid-sized for trials with a published cap, below the 1,111-participant average among 15 other Vitiligo trials with a reported enrollment target (82% lower).
The record links to 1 condition, with Vitiligo appearing as the primary indexed condition, and to 2 interventions - of which Afamelanotide and NB-UVB Light is the first listed.
NCT06109649 names 20 study sites across 14 states, led by California, Florida, Georgia.
Frequently Asked Questions
What is clinical trial NCT06109649 about?
NCT06109649 is a clinical study titled "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". 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.
What is the current status of trial NCT06109649?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 200 participants. The study started on 2023-10-11. Estimated completion is 2026-06.
What conditions does trial NCT06109649 study?
This clinical trial studies the following conditions: Vitiligo.
What interventions are being tested in trial NCT06109649?
The interventions under investigation include: Afamelanotide and NB-UVB Light (DRUG), NB-UVB Light (PROCEDURE).
Who is sponsoring clinical trial NCT06109649?
This trial is sponsored by Clinuvel, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06109649 being conducted?
This trial has 20 study locations across Alabama, California, District of Columbia, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Vitiligo
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06109649's enrollment target sits among peer trials
200 4th of 15 higher than 12 of 15 other Vitiligo trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Vitiligo trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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