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临床试验/NCT01083420
NCT01083420Unknown3 期

The Efficacy of Topical Minocycline in Managing Symptomatic Oral Lichen Planus. A Randomized Controlled Trial

Sheba Medical Center0 个研究点目标入组 30 人开始时间: 2010年3月最近更新:
适应症
干预措施
相关药物

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

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

Active Comparator

Dexamethasone 0.01% mouthwash

干预措施: Dexamethasone (Drug)

Minocycline

Experimental

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

研究者

申办方类型
Other Gov

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