Pretreatments of the Skin to Enhance MAL-induced Protoporphyrin IX (PpIX) Accumulation Prior to Photodynamic Therapy (PDT)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 12
- 主要终点
- Protoporphyrin IX (PpIX) fluorescence
研究概览
简要总结
The study investigates the potential of a range of different physical pretreatments to enhance methyl aminolevulinate (MAL)-induced protoporphyrin IX (PpIX) in the skin prior to photodynamic therapy (PDT).
详细描述
The study investigates the potential of a range of different physical pretreatments to enhance methyl aminolevulinate (MAL)-induced protoporphyrin IX (PpIX) in the skin prior to photodynamic therapy (PDT). The pretreatments include: microneedling, sandpaper, curettage, ablative fractional laser and non-ablative fractional laser. 17 treatment areas are mapped on the upper back of the participants. Each participant receives each intervention in a random sequence.
Primary outcome measure: PpIX accumulation after 3 hours incubation with MAL. Secondary outcome measures: pain during treatment and skin reactions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •18 years or older, healthy, fair skinned (skin type I-III)
排除标准
- •Pregnant women
- •Tattoos, moles or scars in treatment area
研究组 & 干预措施
Interventions
All participants receive all interventions.
干预措施: Microneedle pretreatment + MAL-PDT (Procedure)
Interventions
All participants receive all interventions.
干预措施: Sandpaper pretreatment + MAL-PDT (Procedure)
Interventions
All participants receive all interventions.
干预措施: Curettage pretreatment + MAL-PDT (Procedure)
Interventions
All participants receive all interventions.
干预措施: Ablative Fractional Laser (AFXL) pretreatment + MAL-PDT (Procedure)
Interventions
All participants receive all interventions.
干预措施: Non-Ablative Fractional Laser (NAFXL) pretreatment + MAL-PDT (Procedure)
Interventions
All participants receive all interventions.
干预措施: MAL Control. (Drug)
Interventions
All participants receive all interventions.
干预措施: Untreated Control (Other)
结局指标
主要结局
Protoporphyrin IX (PpIX) fluorescence
时间窗: Day 0
Protoporphyrin IX (PpIX) fluorescence as measured by a fluorescence camera (Medeikonos PDD/PDT, Medeikonos AB,Gothenburg, Sweden).
次要结局
- Pain(Day 0)
- Skin reactions(Day 0, Day 1, Day 3, Day 7)
研究者
Merete Haedersdal
Professor, DMSci, MD
Bispebjerg Hospital