Afamelanotide and Narrow-Band Ultraviolet B (NB-UVB) Phototherapy in the Treatment of Nonsegmental Vitiligo (NSV)

Inclusion Criteria: * for double-blind phase: Male and female subjects with a confirmed diagnosis of nonsegmental vitiligo with 15% to 50% of total body surface involvement * for open label phase: Male and female subjects with a confirmed diagnosis of nonsegmental vitiligo with 10% to 50% of total body surface involvement * Vitiligo involving the head and neck * Stable or slowly progressive vitiligo over a 3-month period * Aged 21 years or more * Willing and able to comply with the conditions specified in this protocol and study procedures, in the opinion of the Investigator * Provided written Informed Consent prior to the performance of any study-specific procedure Exclusion Criteria: * Extensive leukotrichia, in the opinion of the Investigator * Previous treatment with NB-UVB light or other light source within 6 weeks prior to the Screening Visit * Patient not responsive to previous NB-UVB light treatment, defined as a patient who had undergone at least 20 NB-UVB sessions with no or minimal clinically relevant pigmentary response, in the opinion of the Investigator * Previous topical treatment for vitiligo, including topical immunomodulators (e.g. corticosteroids, calcineurin inhibitors), within 4 weeks prior to the Screening Visit * Allergy to afamelanotide or the polymer contained in the implant or to lignocaine/lidocaine or other local anaesthetic to be used during the administration of the implant * History of photosensitivity disorders * Claustrophobia * Any active and/or unstable autoimmune disease judged to be clinically significant by the Investigator * Any current skin disease that may have interfered with the study evaluation * Female who was pregnant (confirmed by positive β-human chorionic gonadotropin (HCG) pregnancy test) or lactating * Female of child-bearing potential (pre-menopausal, not surgically sterile) not using adequate contraceptive measures (i.e. oral contraceptives or diaphragm plus spermicide or intrauterine device) during the treatment phase (7 months) and for a period of three months thereafter - except if abstinence from intercourse was practiced * Sexually active man with a partner of child-bearing potential (pre-menopausal, not surgically sterile) who was not using adequate contraceptive measures, as described above * Participated in a clinical trial for an investigational agent within 30 days prior to the Screening Visit