A Pilot Study to Investigate the Use of Topical Levulan® With Vbeam® Laser for the Treatment of Actinic Keratoses
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Extent That the PpIX is Photobleached by the Treatment Light
研究概览
简要总结
RATIONALE: Photodynamic therapy uses a drug that becomes active when it is exposed to a certain kind of light. When the drug is active, abnormal cells are killed. Photodynamic therapy using topical aminolevulinic acid may be effective against actinic keratosis.
PURPOSE: This randomized clinical trial is studying how well different photodynamic therapy regimens using topical aminolevulinic acid work in treating patients with actinic keratosis.
详细描述
OBJECTIVES:
Primary
- To determine, using fluorescence measurements, the protoporphyrin IX (PpIX) accumulation in thin actinic keratoses (AK) and actinically damaged skin on the face, scalp, and upper torso (stratum 1) and the PpIX accumulation in thick AK and actinically damaged skin on the arms and legs (stratum 2) as a function of skin preparation, aminolevulinic acid (ALA) application time, and body site.
- To determine the extent that the PpIX is photobleached by the treatment light.
Secondary
- To assess the effects of different treatment conditions on acute reactions of AK and sun damaged skin to ALA-photodynamic therapy (PDT) occurring 24-48 hours after PDT.
- To assess the effects of different treatment conditions on the efficacy of ALA-PDT.
- To examine the histological response to ALA-PDT.
- To determine, using fluorescence measurements, the PpIX accumulation in incidental thick AK that may occur in stratum 1, and the PpIX accumulation in incidental thin AK that may occur in stratum 2 as a function of skin preparation, ALA application time and body site.
- To determine the extent that the PpIX in these incidental lesions is photobleached by treatment light.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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 120 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Arm 1 - ALA
Patients receive topical ALA topical (aminolevulinic acid) 2 hours before PDT.
干预措施: aminolevulinic acid (Drug)
Arm 2
Patients receive topical ALA topical (aminolevulinic acid) 4 hours before PDT
干预措施: aminolevulinic acid (Drug)
Arm 3
Patients receive topical ALA (aminolevulinic acid) 24 hours before PDT. Each anatomic area is divided into subunits (e.g., right and left arm, right and left side of the face). The subunits are randomized to receive 1 or 2 pulses of the laser treatment
干预措施: aminolevulinic acid (Drug)
Arm 4
Vbeam laser pulse (photodynamic therapy) is applied to the subunit
干预措施: laser therapy (Procedure)
Arm 5
Vbeam laser pulses (photodynamic therapy) are applied to the subunit. Patients may receive up to 3 treatments (including pretreatment, ALA, and PDT) at least 1 month apart
干预措施: laser therapy (Procedure)
结局指标
主要结局
Extent That the PpIX is Photobleached by the Treatment Light
Protoporphyrin IX (PpIX) Accumulation as a Function of Skin Preparation, Aminolevulinic Acid Application Time, and Body Site
次要结局
- Extent That the PpIX is Photobleached by the Treatment Light in Incidental Lesions
- Histological Response
- Effects of Different Treatment Conditions on Efficacy
- Effects of Different Treatment Conditions on Acute Reactions of Actinic Keratoses (AK) and Sun Damaged Skin Occurring 24-48 Hours After Photodynamic Therapy
- PpIX Accumulation in Incidental AK as a Function of Skin Preparation, Aminolevulinic Acid Application Time, and Body Site