Evaluation of the Chemo-preventive Effect of Combined Topical and Systemic Metformin on Oral Leukoplakia: A Randomized Clinical Trial
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 34
- 试验地点
- 1
- 主要终点
- Change in lesion size
研究概览
简要总结
There is no consensus on treatment of leukoplakia but surgical excision is the preferred choice if suitable in size, which does not prevent clinical recurrence and malignant transformation. Chemoprevention is a new direction in the management of OL using various topical and systemic agents such as; vitamin A, lycopene, celecoxib, green tea extract, and metformin.
While metformin cannot realistically be used as cancer mono-therapy, it can be used as an adjunct and can have a more promising effect on lesions that have yet to undergo malignant transformation. Thus, the aim of this study is to investigate the efficacy of combined chemo-preventive effect of topical and systemic Metformin on oral leukoplakia.
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
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adult patients over 21 years.
- •Patients clinically diagnosed and histologically confirmed as having oral Leukoplakia.
- •Lesions with mild to moderate degree of dysplasia.
- •Patients who agree to sign a written consent after understanding the nature of the study.
排除标准
- •Patients with lesions showing sever degree of dysplasia.
- •Patients who have cardiovascular, lung, Renal, Liver diseases
- •Patients on metformin therapy (eg: Diabetes Mellitus, PCOS, …etc.)
- •Patients on H2 blocker & proton pump inhibitors therapy as Ranitidine (affects metformin absorption and clearance)
- •Those with allergy or sensitivity to Metformin therapy or having any contraindication for their use.
- •Patients on Retinoid, green tea supplements or another natural products therapy
- •Patients with other accompanying oral lesions
- •Pregnant or Lactating females
研究组 & 干预措施
Topical and systemic metformin
干预措施: Metformin Hydrochloride (Drug)
Topical and systemic Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change in lesion size
时间窗: over 6 months
the lesion will be measured in size by periodontal probe bi-dimensionally in mms
次要结局
未报告次要终点
研究者
Mohamed Refaat Elmohamady Soliman Ghanem
Principal Investigator
Cairo University