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Comparing SCENESSE and UV light treatment for 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

Phase 3 Interventional Clinuvel Pharmaceuticals Limited · NCT06109649

This study is testing if adding a medication called afamelanotide to UV light treatment can help people with vitiligo see better results than using UV light alone.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment200 (estimated)
Ages12 Years and up
SexAll
SponsorClinuvel Pharmaceuticals Limited Industry-sponsored
Locations30 sites (Birmingham, Alabama and 29 other locations)
Trial IDNCT06109649 on ClinicalTrials.gov

What this trial studies

This study evaluates the effectiveness and safety of afamelanotide combined with narrow-band ultraviolet (NB-UVB) light compared to NB-UVB light alone in treating patients with vitiligo. It aims to determine if the addition of afamelanotide can enhance the treatment outcomes for individuals with this skin condition. Participants will be monitored for changes in their vitiligo severity and any potential side effects from the treatments.

Who should consider this trial

Good fit: Ideal candidates are males and females aged 12 and older with a confirmed diagnosis of generalized vitiligo and specific severity criteria.

Not a fit: Patients with Fitzpatrick skin types I-II or those with a history of certain skin conditions may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could significantly improve skin pigmentation and quality of life for patients with vitiligo.

How similar studies have performed: Other studies have shown promising results with similar approaches, indicating potential for success in this trial.

Eligibility criteria

Show full inclusion / exclusion criteria 
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
* 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
* Extensive tattoos

Where this trial is running

Birmingham, Alabama and 29 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Vitiligo
Last reviewed 2026-06-15 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.