A Phase III, Randomised, Double-Blind, Placebo Controlled Study to Evaluate the Safety and Efficacy of Subcutaneous Implants of CUV1647 in Patients Suffering From Polymorphic Light Eruption (PLE).
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 3
- 主要终点
- To evaluate whether afamelanotide (CUV1647) prevents episodes or reduces the severity of PLE symptoms in patients with a well documented history of PLE
研究概览
简要总结
The purpose of this study is to determine whether the afamelanotide (CUV1647) formulation is effective in preventing PLE episodes or reducing the severity of PLE symptoms in patients with a well documented history of the disease. The study also aims to determine whether treatment with afamelanotide (CUV1647) can reduce the use of rescue medication in this group.
详细描述
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.
研究设计
- 研究类型
- Observational
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
To evaluate whether afamelanotide (CUV1647) prevents episodes or reduces the severity of PLE symptoms in patients with a well documented history of PLE
时间窗: 18 months
次要结局
- To evaluate the safety and tolerability of afamelanotide (CUV1647) in this specific clinical setting(18 months)
- To evaluate the effect of afamelanotide (CUV1647) on melanin density levels as measured by skin reflectance(18 months)
- To evaluate whether afamelanotide (CUV1647) has a beneficial effect on the quality of life of patients with a documented history of PLE(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(18 months)