The Efficacy of Topical Minocycline in Managing Symptomatic Oral Lichen Planus. A Randomized Controlled Trial
试验速览
- 阶段
- 3 期
- 入组人数
- 30
- 主要终点
- symptoms relief
研究概览
简要总结
The aim of the present study is to assess the clinical efficacy of topical minocyclin in managing of symptoms associated with oral lichen planus (OLP). The rationale of the study is based on our previous studies demonstrating the beneficial effect of minocyclin mouthwash on recurrent aphthous stomatitis. The planned study will be a randomized controlled, cross-over trail. Patients with symptomatic OLP will randomly receive minocycline or dexamethasone rinses.
The patients will rinse and expectorate 5 ml of the 1st mouthwash 4 times daily for 14 days. Subjects will complete a daily follow-up form that includes data regarding the daily intensity of pain (using VAS) caused by OLP and regarding possible side effects. After a washout period (at least 14 days) the patients will repeat the protocol with the second mouthwash.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •OLP patients (Biopsy proven)
排除标准
- •Known allergy to Dexamethasone or Minocycline
- •Pregnancy
研究组 & 干预措施
Dexamethasone
Dexamethasone 0.01% mouthwash
干预措施: Dexamethasone (Drug)
Minocycline
Minocycline 0.2% mouthwash
干预措施: Minocycline (Drug)
结局指标
主要结局
symptoms relief
时间窗: 2 years
次要结局
未报告次要终点
