Non-interventional Study Investigating Photodynamic Therapy With Artificial Daylight Under Routine Clinical Conditions in Patients With Actinic Keratosis (ArtLight)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 224
- 试验地点
- 1
- 主要终点
- Real-world applicability of the ADL-PDT
研究概览
简要总结
The objective of this non-interventional study (NIS) is to gain comprehensive insights into the practicability of ADL-PDT with Metvix® in patients with actinic keratoses under real-world conditions.
详细描述
The objective of this non-interventional study (NIS) is to gain comprehensive insights into the practicability of ADL-PDT with Metvix® in patients with actinic keratoses under real-world conditions. Furthermore, this NIS will document the efficacy, satisfaction, safety and tolerability of ADL-PDT with Metvix® in routine use according to the label.
The observational study is designed as a multicenter study, covering all parts of Germany. Participating investigators are dermatologists experienced in ADL-PDT with an adequate pool of patients with actinic keratoses. The observation time per patient will comprise up to 6 months, including up to 4 visits.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Written informed consent to participate in the study
- •Age ≥18 years
- •Thin or non-hyperkeratotic and non-pigmented actinic keratoses (AK) on the face or scalp (Olsen grade 1 or Olsen grade 2)
- •The decision to undergo ADL-PDT with Metvix® was made independently of this study
- •No contraindication (according to the SmPC)
排除标准
- •Hypersensitivity to the active substance or to one of the other ingredients listed in section 6.1 of the SmPC or other ingredients, including peanut oil, peanut or soy.
- •Morpheaform basal cell carcinoma
- •Porphyria
- •Pregnancy
结局指标
主要结局
Real-world applicability of the ADL-PDT
时间窗: 3 months after treatment
Rate of resolved AK lesions in the focal region
次要结局
- Change in skin quality over the course of the study overall and in the focus region(3 months after treatment)
- Change in AKASI score over the course of the study(3 months after treatment)
- Performance of artificial daylight exposure (artificial daylight system used)(3 months after treatment)
- Occurrence of local skin irritations or adverse events(3 months after treatment)
- Assessment of satisfaction by the patient(3 months after treatment)
- Change in the number of lesions over the course of the study(3 months after treatment)
- Pain during and 5 min after artificial daylight exposure on a visual pain scale of 4 (moderate) to 10 (severe)(3 months after treatment)
- Query of the type of skin preparation by the investigator(3 months after treatment)
- Overall assessment of efficacy, tolerability, adherence, cosmetics by the investigator(3 months after treatment)