NCT01256424已完成2 期
A Randomized Phase II Dose-finding Study of Hexaminolevulinate (HAL) Photodynamic Therapy (PDT) in Patients With Low/Moderate-grade Cervical Intraepithelial Neoplasia (CIN1 or 2)
Photocure2 个研究点 分布在 2 个国家目标入组 262 人开始时间: 2011年4月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 262
- 试验地点
- 2
- 主要终点
- Comparison of Lesion Response Rates of Three Different Doses of HAL PDT and Placebo at 3 Months After Treatment.
研究概览
简要总结
An effective and safe medical therapy would be most welcome to reduce the need for surgical interventions and related adverse events and psychological impact on patients with cervical cancer precursors. In this clinical trial, the investigators propose to evaluate the efficacy and safety of photodynamic therapy (PDT) using hexaminolevulinate (HAL) for mild to moderate-grade CIN (grade 1-2).
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients with ectocervical CIN1 or CIN2 as verified by local pathology (biopsy) obtained within the last month
- •Satisfactory colposcopy examination including:
- •visibility of entire transformation zone including the squamocolumnar junction and
- •visibility of entire lesion margin
- •Negative endocervical os by colposcopy
- •Colposcopical visible lesion at visit 2, before treatment
- •Patients with an average sized uterine cervix (approximately 27mm diameter) suitable for application of the Klemcap
- •Age 18 or above
- •Written informed consent signed
排除标准
- •Previous treatment of CIN or invasive disease
- •Lesion(s) extending to the vaginal vault
- •Atypical glandular cells (AGC) or adenocarcinoma in situ (AIS) on cytology, malignant cells on cytology or histology or other suspicion of either micro-invasive or invasive disease
- •Suspicion of endocervical disease on colposcopy
- •Current severe pelvic inflammatory disease, severe cervicitis, or other severe gynaecological infection as per colposcopy and clinical examination
- •Undiagnosed vaginal bleeding
- •History of toxic shock syndrome
- •Known or suspected porphyria
- •Known allergy to hexaminolevulinate or similar compounds (e.g. methyl aminolevulinate or aminolevulinic acid)
- •Pregnancy, or intention to become pregnant during the study period
- •Childbirth or miscarriage within six weeks of enrolment
- •Use of heart pacemaker
- •Participation in other clinical studies either concurrently or within the last 30 days
- •Risk of poor protocol compliance. Patient participation should be considered with respect to living far away from the hospital, plans for moving to another city/state, frequent travelling, planning to become pregnant, drug abuse/alcoholic, difficult working hours, family obligations, other illness (e.g. psychiatric), etc.
- •Unwillingness to use adequate birth control (not abstinence) from screening until last PDT
- •Patient is the investigator or any sub-investigator, research assistant, pharmacist, study coordinator, other staff or relative thereof directly involved in the conduct of the protocol
研究组 & 干预措施
HAL 5% with illumination
Experimental
HAL PDT 5%
干预措施: HAL 5% with illumination (Drug)
HAL 1% with illumination
Experimental
HAL PDT 1%
干预措施: HAL 1% with illumination (Drug)
HAL 0.2% with illumination
Experimental
HAL PDT 0.2%
干预措施: HAL 0.2% with illumination (Drug)
Placebo ointment without illumination
Placebo Comparator
Placebo without illumination
干预措施: Placebo ointment without illumination (Drug)
结局指标
主要结局
Comparison of Lesion Response Rates of Three Different Doses of HAL PDT and Placebo at 3 Months After Treatment.
时间窗: 3 months after last treatment
Lesion response was defined by three variables: Histology, cytology and HPV. Patient response at three months required histology regression to CIN1 or normal, cytology of LSIL or less severe, and HPV negative.
次要结局
- Comparison of HPV Response of Three Different Doses of HAL PDT and Placebo at 3 Months After Treatment.(3 months after treatment)
研究者
研究点 (2)
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