A BLIND, CONTROLLED CLINICAL STUDY TO EVALUATE THE EFFICACY AND SAFETY OF KAM1403 GEL TREATMENT IN PATIENTS WITH RADIATION DERMATITIS
试验速览
- 阶段
- 2 期
- 发起方
- Kamedis Ltd.
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Changes in Radiation dermatitis symptoms
研究概览
简要总结
The main purpose of this study is to demonstrate the safety and efficacy of KAM1403 GEL in reducing the symptoms of mild to moderate Radiation Dermatitis. Efficacy will be evaluated by comparing symptoms assessment during and post radiotherapy: erythema, desquamation, edema, moist desquamation and ulceration in the KAM1403 Gel treated group versus a group of subjects treated with the Aloe vera Gel (the control group). In addition, a comparison will be made between subjects' self evaluation in the treatment group versus the control group. Safety will be determined by the number and severity of Adverse Events Device-Related.
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
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female above 18 years of age
- •Diagnosed with breast cancer and scheduled to receive postoperative radiotherapy
- •Treatment of regional lymph nodes (i.e. axillary, supraclavicular, or internal mammary) is allowed.
- •Schedule for breast radiotherapy (RT) to a dose of 50 Gy in 2 Gy/fx, for 5 weeks and then a boost to the lumpectomy cavity.
- •Minimum of 3 weeks from chemotherapy to start of radiation therapy.
- •Patient agrees to use only the test products during the study period
排除标准
- •Tumor involvement of the skin
- •Patient has another dermatological disease/condition that could interfere with clinical evaluation including infected atopic dermatitis lesions
- •Patient has a previous history of allergy to the ingredients of the tested formulations
- •Paget's disease of the nipple.
- •Pregnant or lactating females
结局指标
主要结局
Changes in Radiation dermatitis symptoms
时间窗: Day 0, weeks 2, 4, 6.5, 8.5
Changes in Radiation dermatitis symptoms assessment during and post radiotherapy (erythema, desquamation, edema, moist desquamation and ulceration) using the Radiation Therapy Oncology Group toxicity scoring system in the treatment group versus the control group
次要结局
- Number of Adverse Events(Day 0, weeks 2, 4, 6.5, 8.5)
- Subjects' self evaluation(Day 0, weeks 2, 4, 6.5, 8.5)