Effectiveness of Matrix Metalloproteinase Neutralizing Agent in Treatment of Oral Lichen Planus: A Pilot Study
试验速览
- 阶段
- 早期 1 期
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- change in disease severity score
研究概览
简要总结
The current study will be conducted to evaluate the effectiveness of matrix metalloproteinases inhibitors on erosive oral lichen planus.
详细描述
Matrix metalloproteinases inhibitor (Orochem) will be given to patients with Oral erosive lichen planus three times daily for 3 weeks. Then the subjective discomfort and pain severity as well as the objective disease severity scores will be collected.
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
- Triple (Participant, Investigator, Outcomes Assessor)
盲法说明
participant, investigator as well as outcome assessor are blinded
入排标准
- 年龄范围
- 25 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •patients diagnosed with erosive OLP confirmed with a biopsy.
- •patients should have symptomatic lesions
排除标准
- •Patients who were under anticoagulant medications, suffering from any systemic diseases or having any physical or mental abnormality, pregnant and lactating women, smokers.
研究组 & 干预措施
Orochem (Test)
fifteen patients with lichen planus will be treated with MMPs neutralizing agent 3 times daily for 3 weeks. then pain, discomfort and disease severity will be assessed at 1 and 3 weeks periods.
干预措施: Matrix Metalloproteinase Inhibitors (Orochem) (Drug)
Conventional (Control)
fifteen patients with oral lichen planus confirmed with a biopsy will be treated with topical corticosteroids, topical antifungal 3 timed daily for 3 weeks. then pain, discomfort and disease severity will be assessed at 1 and 3 weeks periods.
干预措施: Kenacort A, (Drug)
结局指标
主要结局
change in disease severity score
时间窗: change in disease severity score from baseline to 3 weeks
Thongprasom disease severity score (5-0)
次要结局
未报告次要终点
研究者
Jaylane kadry Ghonima
assistant lecturer
Alexandria University