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ACTIVE NOT RECRUITING 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

NCT06109649 · View on ClinicalTrials.gov ↗

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.

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

FieldValue
Enrollment Target 200 participants
Start Date 2023-10-11
Est. Completion 2026-06
Phase Phase 3

Sponsor

Clinuvel

1 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT06109649

The ClinicalTrials.gov registry entry for NCT06109649 describes a study currently listed as active not recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 200 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Clinuvel, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT06109649 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, Florida, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT06109649?

The interventions under investigation include: Afamelanotide and NB-UVB Light (DRUG), NB-UVB Light (PROCEDURE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT06109649?

This trial is sponsored by Clinuvel, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

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.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial