Efficacy and Safety of Cryotherapy Versus 5-Fluorouracil in the Treatment of Actinic Keratosis: A Prospective, Randomized Controlled, Intra-Individual Trial
试验速览
- 阶段
- 4 期
- 状态
- Enrolling By Invitation
- 入组人数
- 73
- 试验地点
- 1
- 主要终点
- Partial clearance rate
研究概览
简要总结
The goal of this clinical trial is to compare the effectiveness and safety of two treatments-cryotherapy and 5-Fluorouracil (5-FU)-for actinic keratosis, a common skin condition caused by long-term sun exposure. Cryotherapy is a treatment that uses extreme cold produced by liquid nitrogen to freeze and destroy abnormal cells, and 5-FU is a topical cream applied to the skin to treat lesions by interfering with cell growth. The main questions this trial aims to answer are:
- Which treatment, cryotherapy or 5-FU, is more effective in reducing the number of actinic keratosis lesions?
- What are the side effects associated with each treatment?
- How do these treatments impact patient satisfaction, cosmetic outcomes, and health-related quality of life?
Participants will:
- Undergo a baseline assessment where their demographics information such as age, sex, race, smoking status, and medical history are recorded, along with the number and severity of actinic keratosis lesions.
- Receive both cryotherapy and 5-FU, with each treatment applied to different areas of their body. The area of the body to receive each treatment is decided by a random process (like flipping a coin).
- Complete weekly surveys to monitor for side effects during and after the treatment period.
- Return to the clinic for follow-up assessments at 3 months and 12 months.
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
- 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
- •18 years of age or older
- •Has a clinical diagnosis of 10 or more AKs in the head, neck, or extremities areas
- •Able to give informed consent themselves
- •Willing to return for follow up visits
排除标准
- •Cognitively Impaired
- •Incarcerated
- •Non-English speakers
- •Immuno-comprised status
- •Received any kind of treatment for AK within the past 2 months
- •Use of systemic retinoids within the past 3 months
- •Suspicion of cancer in the target area
- •Porphyria
- •Genetic skin cancer disorders
- •Allergy to trial drugs or peanut/soy products
- •Pregnancy or breast-feeding
研究组 & 干预措施
Cryotherapy and 5-Fluoruracil
Each actinic keratosis lesion, or treatment area, will be randomly assigned to receive either cryotherapy or 5-fluoruracil treatment.
干预措施: Cryotherapy (Procedure)
Cryotherapy and 5-Fluoruracil
Each actinic keratosis lesion, or treatment area, will be randomly assigned to receive either cryotherapy or 5-fluoruracil treatment.
干预措施: 5Fluorouracil (Drug)
结局指标
主要结局
Partial clearance rate
时间窗: 3 months and 12 months
Proportion of patients with at least a 75% reduction in the number of baseline AK lesions within the selected treatment area
次要结局
- Recurrence rate(3 months and 12 months)
- Health-Related Quality of Life(3 months and 12 months)
- Patient satisfaction(3 months and 12 months)
- Cosmetic outcome(3 months and 12 months)
- Complete clearance rate(3 months and 12 months)
- Percent reduction of AK lesions(3 months and 12 months)
- Rate of progression to keratinocyte carcinoma(3 months and 12 months)