跳至主要内容
临床试验/EUCTR2018-004222-28-SE
EUCTR2018-004222-28-SE进行中(未招募)1 期

Efficacy of topical treatment with clobetasol in symptomatic oral lichenplanus. A multicenter placebo-controlled randomized clinical trial.

Malmö University0 个研究点目标入组 90 人开始时间: 2020年1月2日最近更新:
适应症
相关药物

试验速览

阶段
1 期
状态
进行中(未招募)
发起方
入组人数
90

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional clinical trial of medicinal product

入排标准

性别
All

入选标准

  • 1. Symptomatic Oral lichen planus.
  • 2. Age > 40 years
  • Are the trial subjects under 18? no
  • Number of subjects for this age range:
  • F.1.2 Adults (18-64 years) yes
  • F.1.2.1 Number of subjects for this age range 30
  • F.1.3 Elderly (>=65 years) yes
  • F.1.3.1 Number of subjects for this age range 60

排除标准

  • 1. Lichenoid contact reactions.
  • 2. Graft versus host disease.
  • 3. Plaque-associated lichenoid reaction.
  • 4. Intraoral diseases with blisters.
  • 5. Ongoing treatment with antibiotics.
  • 6. Ongoing treatment with cortisone or other immunomodulatory drug.
  • 7. Hypersensitivity to clobetasol propionate.
  • 8. Severe periodontitis, as defined by Papapanou et al 2018 (4):
  • CAL > 5 mm, probing depth> 6 mm, furcation involvement 2 and 3.
  • 9. Poor oral hygiene (plaque index [according to Silness-Löe]> 2).
  • 10. Oral lichen planus not verified by biopsy.
  • 11. Hypersensitivity to nystatin.
  • 12. Not reached menopaus.
  • 13. Ongoing or previosly intraoral malignancy.
  • 14. Ongoing participation in another drug study.

研究者

发起方
Malmö University

相似试验