afamelanotide and narrow-band ultraviolet b (nb-uvb) phototherapy in the treatment of nonsegmental vitiligo (nsv)

Conditions: Vitiligo

Summary: the purpose of this study was to evaluate the efficacy and safety of afamelanotide, when combined with narrowband ultraviolet b (nb-uvb) phototherapy, in patients with nonsegmental vitiligo. afamelanotide is expected to increase the rate of the repigmentation induced by nb-uvb, leading to a reduced frequency and dose of nb-uvb.

vitiligo is the most common depigmentation disorder. a commonly used treatment is phototherapy with narrow-band ultraviolet b irradiation (nb-uvb). further therapeutic approaches are desired and currently being evaluated. the investigational product, afamelanotide, is a synthetic analogue of the human alpha melanocyte stimulating hormone (alpha-msh). afamelanotide activates melanin in skin, with the controlled-release injectable implant formulation having an affect across the total body surface area (pandermally). earlier studies in vitiligo patients showed afamelanotide, in combination with nb-uvb, could induce faster and deeper repigmentation in patients compared to nb-uvb alone.

Eligibility criteria:
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