NCT01524744Unknown2 期
A Randomized Clinical Trial of the Effect of Pimecrolimus Cream 1% Compared With Topical Corticosteroid in Treatment of Erosive Oral Lichen Planus
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- signs of oral lichen planus
研究概览
简要总结
The purpose of this study is to compare the effect of topical Pimecrolimus with adcortyl on erosive-atrophic 0ral lichen planus in a randomized clinical trial study.
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 (Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Biopsy confirmed oral lichen planus in combination with a compatible clinical appearance was used for diagnosis.
排除标准
- •Unable to undergo oral biopsy for diagnosis
- •Systemic diseases or malignancy
- •Pregnancy
- •Lesion/lesions with dysplasia/ history of allergic reaction to corticosteroids or immunomodulatory drugs.
- •Lesions adjacent to amalgam filling were also excluded from this study.
研究组 & 干预措施
Pimecrolimus ointment 0.1 %
Active Comparator
This group used drugs 3 times a day for 2 months and then didn't eat or drink for 20 minutes after use
干预措施: Pimecrolimus ointment (Drug)
Pimecrolimus ointment 0.1 %
Active Comparator
This group used drugs 3 times a day for 2 months and then didn't eat or drink for 20 minutes after use
干预措施: Adcortyl (Drug)
Adcortyle
Active Comparator
Control group used adcortyle (triamcinolone acetonide 0.1% in orabase, Bristol-Myers Squibbb, Anagn, Italy)
干预措施: Adcortyl (Drug)
结局指标
主要结局
signs of oral lichen planus
时间窗: every 2 weeks
size and type of oral lichen planus has been recorded
次要结局
- symptoms of oral lichen planus(every 2 weeks)
研究者
ATESSA PAKFETRAT
Associate professor
Mashhad University of Medical Sciences
研究点 (1)
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