NCT00130572已完成3 期
Randomized Placebo-Controlled Clinical Pilot Trial Regarding the Efficacy of Elidel Cream on Erosive Oral Lichen Planus
适应症
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Reduction of a symptom score consisting of involved mucosal area and appearance of pain before and after treatment
研究概览
简要总结
The purpose of this study is to investigate whether topical applied pimecrolimus will lead to improvement of erosive oral lichen planus. This effect will be monitored by reduction of erosive mucosal area and reduction of patient's pain symptoms.
详细描述
Oral lichen planus is a mucosal inflammatory disease of unknown origin. It can be very painful especially if erosions appear on the oral mucosa.
In this study the efficacy of pimecrolimus compared to placebo in treatment of erosive oral lichen planus will be investigated. To this end the subjective pain and the amount of affected mucosa will be monitored before and after treatment.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Clinically and histologically confirmed diagnosis of erosive oral lichen planus
- •Spontaneous or meal related oral pain
- •No topical therapy 2 weeks prior to study start
- •No systemic therapy 4 weeks prior to study start
- •Signed informed consent
排除标准
- •Pregnant or breast-feeding women
- •Known allergy to macrolide antibiotics
- •Known current active malignant disease or in patient's history
- •Known immunodeficiency or HIV infection
- •Participation at another clinical trial within the last 6 months
结局指标
主要结局
Reduction of a symptom score consisting of involved mucosal area and appearance of pain before and after treatment
次要结局
- Patient's and investigator's global assessment after 4 and 8 weeks
- Pimecrolimus blood level after 4 weeks
研究者
研究点 (2)
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