Daylight Photodynamic Therapy for Actinic Keratosis and Skin Field Cancerization - Clinical and Histopathological Analysis
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Clinical improvement
研究概览
简要总结
Twenty patients with multiple actinic keratosis on the face will be enrolled in the study and will be treated with Daylight Photodynamic therapy.
Before and after skin biopsies will be performed, for histological and immunohistochemical analysis.
详细描述
Twenty patients with multiple thin actinic keratosis (AK) on the face will be included in the study. They will be informed of the procedure in detail and sign a consent form.
Digital photographs will be done in a standardized way. Prior to treatment, all patients will undergo 2 skin biopsies under local anesthesia and with a 2 mm punch biopsy. One biopsy will be done over an AK lesion and the other in an area with no apparent AK (field cancerization).
The patients will be treated with Daylight Photodynamic Therapy, following these steps:
- mild curettage of the AK lesions
- application of a chemical sunscreen with sun protection factor (SPF) 30
- application of methyl Aminolevulinate cream (Metvix R, Galderma Laboratories)
- exposition to daylight, for 120 minutes
- cleaning of the face
Three months after treatment, two new skin biopsies will be collected, 1cm away from the initial biopsies. On the same date, new photographs will be made following the same standards as pre-treatment photographs.
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
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •multiple (at least five) actinic keratosis on the face, grades I and II
排除标准
- •phototypes IV, V and VI
- •patients treated for actinic keratosis up to 6 months before
- •history of allergy to methyl aminolevulinate
- •history of photoallergy
- •pregnancy
研究组 & 干预措施
Actinic Keratosis
Twenty patients with multiple thin AK on the face will be treated with Daylight Photodynamic Therapy with methyl aminolevulinate Skin biopsies before and after treatment will be performed in an AK lesion and in a field cancerization area.
干预措施: Methyl Aminolevulinate (Drug)
结局指标
主要结局
Clinical improvement
时间窗: 3 months after treatment
Counting of Actinic keratosis
次要结局
- Histological changes(3 months after treatment)
- immunochemistry changes(3 months after treatment)
研究者
BENI MOREINAS GRINBLAT
Principal Investigator
University of Sao Paulo General Hospital