A Pilot Study of Photodynamic Therapy (PDT) Using Aminolaevulinic Acid (ALA) in Patients With HPV+ Low Grade Cervical Intraepithelial Neoplasia (LSIL;CIN1)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 4
- 主要终点
- Complete response rate
研究概览
简要总结
This trial will study the effectiveness of photodynamic therapy with aminolaevulinic acid for the treatment of patients with HPV+ low grade cervical intraepithelial neoplasia (LSIL;CIN1).
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 25 Years 至 50 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Premenopausal women, 25-50 years of age
- •Diagnosed with LSIL/CIN1 by local pathology (biopsy) and high-risk HPV positive by HC2 assay within the last 3 months
- •Satisfactory colposcopy examination (visibility of entire transformation zone and entire lesion margin )
- •Meet the following conditions: pregnancy test negative; no pregnancy plan during the trial; no sexuality or reliable contraceptive measures taken since last menstruation to the onset of the study, agreeing to adopt reliable contraceptive measures during the study
- •Written informed consent signed
排除标准
- •ASC-H (atypical squamous cells, cannot exclude HSIL) or HSIL (high-grade squamous intraepithelial lesions) or AGC (atypical glandular cells) or AIS (adenocarcinoma in situ) on cytology, or malignant cells on cytology or histology, or other suspicion of either micro-invasive or invasive disease
- •Invasive carcinoma possibility or lesions extending to the vaginal vault or suspicion of endocervical disease on colposcopy
- •Severe pelvic inflammatory disease, severe cervicitis, or other severe gynaecological infection as per clinical examination
- •Undiagnosed vaginal bleeding
- •With allergic disease at present; known or suspected porphyria; known allergy to ALA or analogues
- •With serious cardiovascular, neurologic, psychiatric, endocrine, hematological disease; immunocompromised conditions; patients with malignant tumors
- •Hepatic or renal functions abnormal (alanine aminotransferase or aspartate transaminase or total bilirubin > 1.5 upper limit of normal [ULN], or serum creatinine or blood urea nitrogen > 1.5 ULN)
- •Pregnancy or nursing
- •Previous physical therapy of LSIL/CIN1 after pathologic diagnosis
- •Participation in any clinical studies within the last 30 days
- •Subjects that the investigators judged to be not suitable to participate the study besides above
研究组 & 干预措施
ALA
Patients will receive 3 topical treatments of aminolaevulinic acid 500mg
干预措施: Aminolaevulinic acid (Drug)
Placebo
Patients will receive 3 topical treatments of placebo 500mg
干预措施: Placebo (Drug)
结局指标
主要结局
Complete response rate
时间窗: 3 months after treatments
Based on histology, cytology and HPV status. "Complete response" is defined as normal pathology, normal cytology and negative HPV.
Response rate
时间窗: 3 months after treatments
Based on histology, cytology and HPV status. "Response" is defined as: 1) pathology and cytology were both normal; 2) pathology and/or cytology showed low grade and the baseline HPV infection was cleared.
Clearance of high risk HPV
时间窗: 3 months after treatments
Proportion of patients with high risk HPV clearance
次要结局
未报告次要终点