Impact of Topical Clobetasol on Gingival Crevicular Fluid miRNAs in Subjects Affected by Oral Lichen Planus: a Randomized Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 62
- 试验地点
- 2
- 主要终点
- miRNAs GCF levels
研究概览
简要总结
According to recent research, microRNAs (miRNAs) may function as early disease indicators and contribute to the severity of a number of precancerous and malignant oral disorders. The aim of the present study, through a double-blind randomized controlled trial design, is to analyze in the gingival crevicular fluid (GCF) as a non-invasive approach the impact of topical clobetasol on miRNAs expression in subjects affected by oral lichen planus (OLP).
详细描述
A double-blind randomized controlled clinical trial is conducted in order to evaluate the impact of topical clobetasol on GCF miRNAs expression in subjects with OLP and determine the statistical significance of the outcome variables.
At least 60 patients with OLP, randomly allocated in two groups: placebo group with a 4% hydroxyethyl cellulose adhesive gel and the clobetasol group with the same gel containing clobetasol propionate 0,05%.
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
- Double (Participant, Investigator)
盲法说明
Sealed envelopes
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •The complete correspondence of the most recent WHO clinical and histopathological criteria (2020) for OLP diagnosis.
排除标准
- •1) Previous therapies for OLP during the last six months preceding the study; 2) State of pregnancy or breastfeeding; 3) Contact or drug oral lichenoid lesions; 4) Allergies to the molecules used in the study; 5) HIV seropositivity.
研究组 & 干预措施
Placebo
Patients were treated with a topic placebo gel control
干预措施: Placebo (Drug)
Clobetasol propionate 0,05% gel
Patients were treated with a topic gel of clobetasol propionate 0,05%
干预措施: Clobetasol Topical Gel (Drug)
结局指标
主要结局
miRNAs GCF levels
时间窗: 8 weeks
The level of expression of different miRNAs in the GCF before and after treatment in the two groups. (Scale 0-4)
miRNAs GCF levels
时间窗: 6 months
The level of expression of different miRNAs in the GCF before and after treatment in the two groups. (Scale 0-4)
次要结局
- OLP disease severity scores(8 weeks)
- OLP disease severity scores(6 months)
研究者
Gaetano Isola
Researcher
University of Catania