Overview
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.
Eligibility
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