NCT06430190尚未招募不适用
A Prospective, Exploratory Study to Evaluate the Efficacy of Peginterferon α-2b Injection Combined With Carbon Dioxide(CO2) Laser in the Treatment of Condylomata Acuminata
Zhangyu Bu1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年7月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Clinical cure rate
研究概览
简要总结
This is a prospective, randomized, open-label, controlled study, aiming to enroll 30 patients with Condylomata Acuminata. The study consists of two phases: a treatment phase (Weeks W1-W12) and an observation phase (Weeks W13-W24). Eligible patients will be randomly allocated into three groups at a ratio of 1:1:1: Test Group 1, Test Group 2, or the Control Group. And clinical cure, recurrence rates, adverse events, vital signs, laboratory tests, drug exposure doses, premature withdrawals will be analyzed.
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
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be between 18 and 65 years old.
- •Patients with positive of human papillomavirus(HPV) nucleic acid test and acetowhite test, were diagnosed as condyloma acuminatum according to clinical manifestations and epidemiological history.
- •Patients' lesions are located on non-cavity areas such as the foreskin, glans penis, labia majora, labia minora, with a number ranging from 1 to 5 individual lesions, and each individual lesion having a diameter less than 1 centimeter.
- •For female participants with reproductive capability, a negative pregnancy test result is mandatory at the screening stage.
- •Participants must volunteer to enroll in the study and be able to understand and sign a written informed consent form.
排除标准
- •Pregnant women, breastfeeding mothers, or individuals planning to conceive during the study period.
- •Patients who received treatment for genital warts within two weeks prior to screening.
- •Patients with concurrent skin conditions in the affected area that might significantly impact the evaluation of treatment efficacy.
- •Individuals with known severe immunodeficiency or those requiring long-term use of corticosteroids and immunosuppressive agents.
- •Active carriers of hepatitis B virus, hepatitis C virus, human immunodeficiency virus (HIV), or Treponema pallidum (syphilis).
- •Patients with a history of severe cardiovascular, hepatic, renal, endocrine, digestive, immune, respiratory, or nervous system diseases.
- •Patients with severe retinal disorders or other serious ophthalmologic conditions.
- •Patients allergic to interferons or excipients in the medication formulation, or those deemed unsuitable for CO2 laser treatment.
- •Individuals meeting any contraindications listed in the investigational drug's package insert.
- •Patients who participated in another interventional clinical trial within three months before screening, or those planning to participate in another clinical trial during the study period.
- •Other cases deemed inappropriate for enrollment by the investigator due to various reasons.
研究组 & 干预措施
Lesional group
Experimental
干预措施: Peginterferon α-2b injection (Drug)
Lesional group
Experimental
干预措施: CO2 laser (Other)
Systemic group
Experimental
干预措施: Peginterferon α-2b injection (Drug)
Systemic group
Experimental
干预措施: CO2 laser (Other)
Control group
Active Comparator
干预措施: CO2 laser (Other)
结局指标
主要结局
Clinical cure rate
时间窗: Week 12
次要结局
- Recurrence rate(Week 24)
研究者
Zhangyu Bu
Attending Physician
First People's Hospital of Hangzhou
研究点 (1)
Loading locations...
相似试验
Unknown
2 期
All-trans Retinoic Acid (ATRA) in the Treatment of Recurrent/Metastatic Adenoid Cystic Carcinoma of the Head and NeckAdenoid Cystic Carcinoma of the Head and NeckNCT04433169Shanghai Ninth People's Hospital Affiliated to Shanghai Jiao Tong University30
已完成
不适用
G-Wound (VZ for Wound Treatment)WoundsWound HealNCT04417647Glock Health, Science and Research GmbH12
招募中
2 期
A Prospective, Randomized, Controlled Clinical Study on the Prevention of Chemotherapy Related Myelosuppression in Patients with Ewing's Sarcoma Using TrilaciclibMyelosuppressionEwing SarcomaNCT06699472Fudan University22
Unknown
4 期
Post Marketing Study for the Evaluation of Predictix Antidepressant Clinician Software Support Tool in Prescribing Antidepressant Medication/s for the Treatment of Patients Suffering From Major Depressive DisorderMajor Depressive DisorderNCT04138290Taliaz Ltd.30
终止
2 期
Effects of Remodulin in Patients With Critical Limb Ischemia Following a Vein Bypass GraftPeripheral Vascular DiseaseNCT00067041United Therapeutics30