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Official title: 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
The Phase 3 CUV105 trial, sponsored by Clinuvel, Inc., evaluates the safety and efficacy of combining SCENESSE (afamelanotide) with NB-UVB phototherapy for generalized vitiligo, focusing on Fitzpatrick skin types IV–VI to address underrepresented populations. The study aims to determine if this combination therapy achieves superior repigmentation outcomes compared to NB-UVB therapy alone.
Key Details:
- Study Type: Interventional (Clinical Trial)
- Phase: Phase 3
- Estimated Enrollment: Not specified
- Age Range: 12 years and older
- Duration: Approximately 308 days, including treatment and follow-up periods
Eligibility Criteria:
Inclusion:
- Individuals aged 12 years or older
- Confirmed diagnosis of generalized vitiligo with a Vitiligo Area Scoring Index (VASI) of ≥0.3 on the body and face
Exclusion:
- Pregnant or lactating females
- Females of childbearing potential not using adequate contraceptive measures
- History of melanoma or lentigo maligna
- Presence of skin cancer lesions
- Severe liver disease or impairment
- Allergy to afamelanotide or its implant material
Additional Information: Participants will be randomly assigned to receive either NB-UVB light therapy alone or in combination with SCENESSE implants. The study will assess the percentage of patients achieving significant repigmentation, as measured by the VASI scoring system, over the course of the trial. For more details or to inquire about participation, please visit the official trial page.
Start date: 2023-10-11
Completion date: 2025-06-01
Contact: Head of Clinical Operations
Tel.: +441372860765
Email: clinicaltrials@clinuvel.com
Link: https://clinicaltrials.gov/study/NCT06109649
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