A Single-Center, Two-Arm, Prospective Clinical Study Evaluating the Efficacy and Safety of a Topical Periplaneta Americana-Derived Regenerative Solution (Meilian Fuxin Liquid) for the Treatment of Radiation Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 2
研究概览
简要总结
To evaluate the efficacy and safety of topical Periplaneta americana-derived Meilian Fuxin Solution for the prevention of radiation dermatitis in patients undergoing radiotherapy.
详细描述
The clinical trial aims to evaluate the efficacy and safety of topical Periplaneta americana-derived Meilian Fuxin Solution in preventing and reducing radiation dermatitis in patients undergoing radiotherapy. Participants will be assigned to receive either topical Meilian Fuxin Solution or a placebo formulation, applied twice daily to the irradiated skin area from the start of radiotherapy through completion of treatment. The placebo will be administered using an identical application regimen. Radiation dermatitis will be assessed at baseline and at regular intervals during and after radiotherapy using the Radiation Therapy Oncology Group (RTOG) criteria, and safety will be evaluated by monitoring local and systemic adverse events throughout the study period.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age and Gender: Patients aged 18 to 80 years (inclusive of boundary values), regardless of gender.
- •Diagnosis and Treatment: Patients with head and neck cancer (including nasopharyngeal carcinoma) who have been confirmed by histopathology and require radical radiotherapy or postoperative adjuvant radiotherapy.
- •Performance Status: Patients with an ECOG Performance Status score of 0 to
- •Consent: Patients who voluntarily agree to participate in this study and sign the informed consent form.
排除标准
- •Prior Radiotherapy: Patients with a history of prior radiotherapy to the target area.
- •Baseline Skin Condition: Baseline skin condition in the treatment area that may interfere with efficacy assessment (e.g., presence of open wounds, infection, rash, psoriasis, etc.).
- •Systemic Diseases: Presence of connective tissue diseases or other systemic dermatoses.
- •Known Allergies: Known allergy to any component of the investigational product (Meilian Fuxin Solution).
- •Prior Clinical Research: Participation in other interventional clinical studies within the past 3 months and use of any investigational drugs or devices.
- •Investigator Discretion: Subjects judged by the investigator to be unsuitable for participation in this clinical study.
研究者
Xingchen Peng
PhD, Professor
West China Hospital