Phase III Trial of CUV1647 in Polymorphic Light Eruption (PLE)

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.

Inclusion criteria

• Aged 18 - 70 years at inclusion.
• Well documented history of moderate/severe PLE as diagnosed/confirmed by a photodermatologist or photobiologist. Newly diagnosed patients with moderate/severe PLE can be included if numbers of established patients are limited provided their diagnosis is confirmed by a photodermatologist or photobiologist.
• Recurrent episodes that occur at least once a year, developing in own country (to exclude patients affected only when traveling to sunnier climates).
• Have given written informed consent to participate in the study.

Exclusion criteria

• Personal history of melanoma, lentigo maligna or multiple (3 or more) dysplastic nevi.
• Current Bowen's Disease, basal cell carcinoma, squamous cell carcinoma or other malignant skin lesions.
• Documented history of other photosensitive conditions.
• Female who is pregnant (confirmed by positive serum β-HCG pregnancy test prior to baseline) or lactating.
• Females of child-bearing potential that are not using adequate contraceptive measures.