Gene and Protein Expression Profiles After Treatment of Actinic Keratoses
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- Gene and protein expression profiles
研究概览
简要总结
The primary aim of this study is to investigate the effect of 5-fluorouracil, imiquimod, and melatonin for actinic keratosis on immunological gene, and protein expressions profiles. Secondarily, the aim is to assess the effect of the treatment on the histopathology of actinic keratoses.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 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
- 否
入选标准
- •Participants should have a clinical diagnosis of actinic keratosis
- •Participants should be 18 years old or above
- •Participants must sign an informed consent
排除标准
- •Known allergic reaction to either 5-fluorouracil , imiquimod, or melatonin
- •Immunomodulating treatment
- •Predictable poor compliance (due to i.e. dementia, substance abuse, psychiatric disease, life-threatening disease or language barriers)
- •Pregnant or breastfeeding
- •Females not in menopause (defined as no menstruation during the last 12 months) should use a secure birth control (intrauterine devices, hormonal contraceptives including - oral pills, patches, vaginal rings and injections) during the entire period of the trial
研究组 & 干预措施
5-Fluorouracil
Patients will be asked apply a 40 mg/g creme containing 5-Fluorouracil once a day on their lesion for 10 days. A biopsy will be taken four days after last application. The patient will be refered to a dermatologist for further treatment, if necessary.
干预措施: 5Fluorouracil (Drug)
Imiquimod
Patients will be asked apply a 50 mg/g creme containing imiquimod thrice a week on their lesion for 10 days. A biopsy will be taken four days after last application. The patient will be refered to a dermatologist for further treatment, if necessary.
干预措施: Imiquimod (Drug)
Melatonin
Patients will be asked apply a 25 mg/g creme containing melatonin once a day on their lesion for 10 days. A biopsy will be taken four days after last application. The patient will be refered to a dermatologist for further treatment, if necessary.
干预措施: Melatonin (Drug)
结局指标
主要结局
Gene and protein expression profiles
时间窗: 10 days of treatment
次要结局
- histopathological assessment of actinic keratoses(10 days of treatment)
研究者
Ismail Gögenur
Professor
Zealand University Hospital