Topical Imiquimod for the Treatment of Oral Dysplastic Lesions With Clinical and Histologic Assessments
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Effectiveness by Clinical Response
研究概览
简要总结
The goal of this clinical trial is to determine the effectiveness of imiquimod in treating oral dysplasia in adult patients. Imiquimod 5% cream could be a safe and practical treatment for oral epithelial dysplasia (a precancerous change in the mouth). The main questions it aims to answer are:
- Does imiquimod help to make the lesions smaller and make the abnormal cell changes less severe?
- How can we make this treatment safer and more feasible?
Participants will apply topical imiquimod cream to treat the oral dysplasia and receive two follow-up biopsies after the treatment.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •The patient has a biopsy-proven diagnosis of oral epithelial dysplasia.
- •The patient is ineligible for or unwilling to undergo surgical or laser therapy.
- •The patient is over 18 years old.
- •The patient agrees to join the study and completes the informed consent process.
排除标准
- •The patient has OL, and excisional surgical removal is indicated.
- •The patient is immunocompromised.
- •The patient is under 18 years old.
- •The patient refused to join the study or did not complete the informed consent process.
研究组 & 干预措施
Patients have topical imiquimod applied to oral dysplasia site
干预措施: Imiquimod (topical use) (Drug)
结局指标
主要结局
Effectiveness by Clinical Response
时间窗: 52 weeks after the start of the participant's treatment course
Clinical response: Change in the size of the lesion. Measurement of the lesion and scored according to RECIST criteria
Effectiveness by histopathological assessment
时间窗: 52 weeks after the start of participant's treatment course
Evaluation of the changes of degree of dysplasia following the WHO three-tier grading of oral dysplasia in which Oral epithelial dysplasia is graded as mild, moderate, and severe.
次要结局
- Frequency of Adverse Effects(24 months)
- Manageability of Adverse effects(24 months)
- Treatment Adherence(24 months)
研究者
Anette Vistoso Monreal
Director of OralCare PreCancer and Pain Clinic
University of Southern California