This study is currently not recruiting participants.

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 (CUV 105)

Not Recruiting
12 years - 99 years
All
Phase 3
5 participants needed
1 Location

Brief description of study

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.

Detailed description of study

We are conducting a Phase III clinical study at the Hospital of the University of Pennsylvania, evaluating the efficacy and safety of SCENESSE® (afamelanotide) implant and NB-UVB compared to NB-UVB alone in treating generalized vitiligo. The study includes:

  • Screening: up to 28 days
  • Treatment: 20 weeks
  • Follow-up: 24 weeks

Eligibility of study

You may be eligible for this study if you meet the following criteria:

  • Conditions: Vitiligo
  • Age: 12 years - 99 years
  • Gender: All

Key Inclusion Criteria:

  • Adults & adolescents ≥12 years
  • Involvement of both face and body
  • Stable or active vitiligo for at least 3 months
  • Fitzpatrick skin types III-VI

 

Key Exclusion Criteria:

  • Fitzpatrick skin types I-II
  • Extensive leukotrichia
  • Recent NB-UVB treatment (<3 months)
  • Pregnancy, lactation, or non-contracepting females
  • Active malignancies or severe hepatic disease

Updated on 22 Oct 2025. Study ID: 24-0735

Interested in the study

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