A Double-Arm, Open Label, Phase III Study to Compare the Efficacy and Saftey of SCENESSE and Narrow-Band Ultraviolet B (NB-UVB) Light versus NB-UVB Light Alone in the Treatment of Vitiligo (CUV 105)
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
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Age: 12 years - 99 years
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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
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