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

Launched by CLINUVEL, INC. · Oct 25, 2023

Keywords

ClinConnect Summary

The CUV105 study is a clinical trial designed to compare two treatment methods for vitiligo, a skin condition that causes patches of skin to lose their color. Specifically, the trial will look at the effectiveness and safety of a medication called SCENESSE (afamelanotide) combined with a special type of light therapy known as narrow-band ultraviolet (NB-UVB) light, compared to using NB-UVB light alone. The goal is to see which method works better for patients with vitiligo affecting their body and face.

To participate in this study, you need to be at least 12 years old and have been diagnosed with generalized vitiligo. This trial is open to both men and women with specific skin types (IV-VI) and varying stages of vitiligo. However, certain individuals, such as those with extensive white hair or a history of certain skin cancers, will not be eligible. If you join the study, you can expect to receive either the new treatment combination or the light therapy alone, and your progress will be closely monitored to ensure safety and effectiveness. This study is currently recruiting participants, so if you or someone you know is interested, it may be a good opportunity to explore new treatment options for vitiligo.

Gender

ALL

Eligibility 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