Diagnosis of Demodex Blapharitis and Treatment With Ivermectin Gel 0.1%/ Metronidazole 1%
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Erradication of Demodex mites
研究概览
简要总结
Blepharitis is a endemic inflammatory disease caused mainly by Demodex folliculorum and Demodex Brevis, This mites are often associated with anaerobic bacteria that produces a skin inflammation, so a intervention that reduces the number of mites and bacteria would be desirable. Ivermectin a macrolid compound have demonstrated activity against scabies and lice in humans and in animals and a single application have show a good response in lice eradication.
In this study , investigators will determinate the security and effectiveness of this compound in the eradication of mites
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, Care Provider)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •• Patients with symptomatic Demodex blepharitis for duration of at least 3 months.
- •Age range: 18 yeras and older.
- •Both genders and all ethnic groups comparable with the local community.
- •Able to understand and willing to sign a written informed consent
- •Able and willing to cooperate with the investigational plan.
- •Able and willing to complete all mandatory follow-up visits.
排除标准
- •• Patients who are currently engaged in another clinical trial, unwilling or unable to give consent, to accept randomization, or to return for scheduled visits.
- •Children under
- •Pregnant women or expecting to be pregnant during the study.
- •Systemic immune deficient conditions such as AIDS or under systemic immunosuppressant.
- •Concomitant use of ophthalmic topical medications (excluding non-preserved tear substitutes).
- •Concomitant use of systemic antibiotics or steroids.
- •Contact lens wear
- •Active ocular infection or allergy
- •Unable to close eyes or uncontrolled blinking Previous allergic reaction to metronidazole and / or ivermectin
研究组 & 干预措施
Ivermectin 0.1% Metronidazole 1%
30 patients will receive the treatment and at 15 days a second visit will be done and changes in mite counts will be determinated and correlated with symtoms and signs.
干预措施: Ivermectin 0.1% Metronidazole 1% (Drug)
Control
30 volunters with no signs of blepharitis and with eyelashes with no demodex .None intervention. Symptoms and signs will be compared with experimental group
干预措施: None intervention (Other)
结局指标
主要结局
Erradication of Demodex mites
时间窗: 2 months
Reduction in mites count after treatment compared to baseline data. If mites are not observed in the last visit a complete eradication will be considered. Patients with one or more mites will be considered as a incomplete eradication
次要结局
- Change in lid margin rednes and bulbar conjunctival hyperemia categorized from 0 (none) to 3 (severe) according to the next score(2 months)