NCT06016361尚未招募不适用
Evaluation of a Novel Amino Acid Based Moisturizing Cream as Part of the Daily Standard Skincare Regimen Recommended During Radiation Therapy
Entrinsic Bioscience Inc.2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2023年9月18日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Reduction in Erythema
研究概览
简要总结
The goal of this clinical study is to evaluate a novel amino acid based moisturizing cream as part of the daily standard skincare regimen recommended during radiation therapy. The main aim of this study is to assess if the investigational product can improve skin redness associated with radiation therapy. Participants will apply a moisturizer daily during the course of their prescribed radiation therapy for breast cancer. Researchers will compare against the standard of care.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
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
- •Provision of signed and dated informed consent form.
- •Aged over 18 years old.
- •Has been diagnosed with breast cancer and prescribed radiotherapy as a part of their cancer treatment.
- •Planned radiotherapy, as prescribed by the oncologist, is expected to provide a total radiation dose of up to 60 gray within the first 4 weeks of treatment.
- •Be able to adhere to proposed daily wound/site care as proposed by the protocol in line with the AADs recommendations.
排除标准
- •Pre-existing skin conditions which in the opinion of the investigator could impact on the integrity of the study or compromise the safety of the patient (i.e., active eczema, psoriasis, or an open wound over the planned site of radiation).
- •Have a concurrent medical condition or poor functional baseline which in the opinion of the investigator would make them unsuitable or able to fully comply with the study protocol.
- •Are pregnant or actively breast feeding.
- •Known allergic reactions to ingredients of the Investigational Product or the Standard of Care.
结局指标
主要结局
Reduction in Erythema
时间窗: Up to 12 weeks
Evaluation of skin redness (both severity and size) with ScarletRed technology
次要结局
未报告次要终点
研究者
研究点 (2)
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