Primary Outcome Measures:
- To evaluate whether afamelanotide (CUV1647) prevents episodes or reduces the severity of PLE symptoms in patients with a well documented history of PLE [ Time Frame: 18 months ]
Secondary Outcome Measures:
- To evaluate the safety and tolerability of afamelanotide (CUV1647) in this specific clinical setting [ Time Frame: 18 months ]
- To evaluate the effect of afamelanotide (CUV1647) on melanin density levels as measured by skin reflectance [ Time Frame: 18 months ]
- To evaluate whether afamelanotide (CUV1647) has a beneficial effect on the quality of life of patients with a documented history of PLE [ Time Frame: 18 months ]
- To determine if there are other factors that may influence the severity of PLE symptoms eg. sun exposure and use of sun protection methods [ Time Frame: 18 months ]
Polymorphic Light Eruption (PLE) is a prevalent photosensitivity disorder, occurring in up to 20% of the European and US populations and up to 5% of the Australian population. The disease is characterised by a rash that is intensely itchy with blisters, bumps and patches presenting on areas of the skin that have been exposed to the sun. There is a lack of effective treatment available for the condition but the most common available forms of therapy include sun avoidance and the use of the use of steroids and/or phototherapy.
