Photodynamic Therapy Using Topical Aminolevulinic Acid in Treating Patients With Actinic Keratosis
A Pilot Study to Investigate the Use of Topical Levulan® With Vbeam® Laser for the Treatment of Actinic Keratoses
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.
研究概览
详细说明
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.
OUTLINE: The randomization is a two-step restricted block process for application time and skin preparation, followed by randomization for light dose (1 vs 2 pulses) within the anatomic site. Within each stratum (stratum 1 or 2), lesions in each separate anatomic area (face and neck, scalp, upper torso; arms, legs) are randomized to receive 1 of 3 pretreatment skin preparation before receiving topical aminolevulinic acid (ALA): pretreatment with acetone, gentle abrading, or no pretreatment. Patients are randomized to receive ALA at different times before the photodynamic therapy (PDT).
- Arm I: Patients receive topical ALA 2 hours before PDT.
- Arm II: Patients receive topical ALA 4 hours before PDT.
- Arm III: Patients receive topical ALA 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.
- Arm IV: 1 Vbeam laser pulse (photodynamic therapy) is applied to the subunit.
- Arm V: 2 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. Patients with progressive lesions or lesions that have not responded after 3 treatments may receive diagnostic biopsy to check for invasive squamous cell carcinoma and referred to treatment off study.
Patients undergo biopsies at baseline, before and after ALA application prior to light treatment, and up to 24 hours after light treatment to analyze cytokines and genes specific to actinic keratoses.
研究类型
注册 (实际的)
阶段
- 不适用
联系人和位置
学习地点
-
-
New York
-
Buffalo、New York、美国、14263-0001
- Roswell Park Cancer Institute
-
-
参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
DISEASE CHARACTERISTICS:
Actinic keratosis lesion located in any of the following body sites:
Stratum 1*: face and neck, scalp, or upper torso
- At least 1 clinically evident thin actinic keratosis on each side of the midline of any of the above areas
Stratum 2*: arms or legs
- At least 1 clinically evident thick actinic keratosis on each arm or leg NOTE: *One patient may be in one or both strata depending on the location of the lesion(s)
- Lesions to be treated on this protocol must not have been previously treated by other modalities for at least 2 months prior to study entry
PATIENT CHARACTERISTICS:
- No porphyria or known hypersensitivity to porphyrins
- No known photosensitivity disease
- No known sensitivity to any components of aminolevulinic acid topical solution
- Not pregnant or nursing
PRIOR CONCURRENT THERAPY:
- Other concurrent topical therapies at lesion sites other than those used in this protocol are allowed
- No other concurrent photosensitizer drugs
学习计划
研究是如何设计的?
设计细节
- 主要用途:治疗
- 分配:随机化
- 介入模型:单组作业
- 屏蔽:无(打开标签)
武器和干预
参与者组/臂 |
干预/治疗 |
---|---|
实验性的:Arm 1 - ALA
Patients receive topical ALA topical (aminolevulinic acid) 2 hours before PDT.
|
|
实验性的:Arm 2
Patients receive topical ALA topical (aminolevulinic acid) 4 hours before PDT
|
|
实验性的: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
|
|
实验性的:Arm 4
Vbeam laser pulse (photodynamic therapy) is applied to the subunit
|
|
实验性的: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
|
研究衡量的是什么?
主要结果指标
结果测量 |
---|
Protoporphyrin IX (PpIX) Accumulation as a Function of Skin Preparation, Aminolevulinic Acid Application Time, and Body Site
|
Extent That the PpIX is Photobleached by the Treatment Light
|
次要结果测量
结果测量 |
---|
Effects of Different Treatment Conditions on Acute Reactions of Actinic Keratoses (AK) and Sun Damaged Skin Occurring 24-48 Hours After Photodynamic Therapy
|
Effects of Different Treatment Conditions on Efficacy
|
Histological Response
|
PpIX Accumulation in Incidental AK as a Function of Skin Preparation, Aminolevulinic Acid Application Time, and Body Site
|
Extent That the PpIX is Photobleached by the Treatment Light in Incidental Lesions
|
合作者和调查者
调查人员
- 首席研究员:Nathalie Zeitouni, MD,、Roswell Park Cancer Institute
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (实际的)
上次提交的符合 QC 标准的更新
最后验证
更多信息
此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.
激光疗法的临床试验
-
University of Applied Sciences and Arts of Southern...Vrije Universiteit Brussel; Universiteit Antwerpen; THIM - die internationale Hochschule für Physiotherapie完全的