A Phase II, Multicentre, Double-blind, Placebo Controlled, Pilot Study to Evaluate the Safety and Efficacy of CUV1647 (Afamelanotide) as Adjunctive Therapy in Patients Undergoing Photodynamic Therapy (PDT) Utilising Porfimer Sodium
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 16
- 主要终点
- The First Day on Which Patients Are Free From Symptoms of Phototoxicity Following Phototesting
研究概览
简要总结
The purpose of this study was to evaluate the safety and efficacy of afamelanotide (previously developed as CUV1647) as adjunctive therapy in patients undergoing photodynamic therapy using porfimer sodium.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female Caucasian subjects undergoing photodynamic therapy with porfimer sodium;
- •Aged greater than 18 years;
- •Written informed consent prior to the performance of any study-specific procedure.
排除标准
- •Known allergy or hypersensitivity to afamelanotide or the polymer contained in the implant;
- •Non-Caucasian patients;
- •Personal history of melanoma or dysplastic nevus syndrome;
- •Current Bowen's disease, basal cell carcinoma, squamous cell carcinoma, or other malignant or premalignant skin lesions;
- •Female who is pregnant (confirmed by positive serum β-HCG pregnancy test prior to baseline) or lactating;
- •Females of child-bearing potential (pre-menopausal, not surgically sterile) not using adequate contraceptive measures (i.e. oral contraceptives, diaphragm plus spermicide, intrauterine device);
- •Participation in a simultaneous clinical trial for another investigational agent or within 30 days prior to the screening visit;
- •Patients unable to give informed consent;
- •Patient needs for concomitant medication with potential photosensitizing effects e.g. antibiotics like tetracyclines.
研究组 & 干预措施
Afamelanotide
Subjects visited the clinic on Day 0 (administration of afamelanotide implant and porfimer sodium), Day 2 (photodynamic therapy), and Days 20 and 90 for assessments of adverse events, concomitant medication and the results of evaluation of phototoxicity.
干预措施: Afamelanotide (Drug)
Placebo
Subjects visited the clinic on Day 0 (administration of placebo implant and porfimer sodium), Day 2 (photodynamic therapy), and Days 20 and 90 for assessments of adverse events, concomitant medication and the results of evaluation of phototoxicity.
干预措施: Placebo (Drug)
结局指标
主要结局
The First Day on Which Patients Are Free From Symptoms of Phototoxicity Following Phototesting
时间窗: From Day 04 to Day 90
次要结局
- Change in Quality of Life(From Day 0 to Day 20, Day 60 and Day 90)