NCT01756313已完成4 期
Optimizing Uptake of Methylaminolevulinat With Fractional Ablative Laser Technique
适应症
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 12
- 试验地点
- 2
- 主要终点
- Fluorescence Intensity
研究概览
简要总结
The objectives of this study is to investigate if pre-treating the skin with an ablative fractional laser that creates small micropores in the skin:
- Increases the uptake of Methylaminolevulinat (MAL) in the skin.
- Decreases the required incubation time of MAL when performing photo dynamic therapy.
详细描述
12 healthy male individuals were included.
On the back, 25 areas measuring 2.8x2.8 cm were marked, plus one control area. We tested 2 variables.
- Density of laser channels. 2) Methylaminolevulinat (MAL) concentration
- Laser - Each area was randomized to receiving:
- no treatment
- 1% laser channel density
- 2% laser channel density
- 5% laser channel density
- 10% laser channel density
- 15% laser channel density
- MAL - Each density was assigned to 4 areas. Within each density category, the four areas were randomized to receive:
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •>18 years old
- •Fitzpatrick skin type I-III
- •No UV exposure thee months prior to study
- •Signed study consent
排除标准
- •Known allergy to substances in MAL or Unguentum M cream.
- •Previous keloid
- •Use of topical or systemic photosensitizing drug
- •Evaluated to not be able to follow treatment protocol
结局指标
主要结局
Fluorescence Intensity
时间窗: up to 3 hours
Fluorescence Intensity measured with a fluorescence camera.
次要结局
未报告次要终点
研究者
研究点 (2)
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