Evaluation of Mucoadhesive Tacrolimus Patch on Caspase-3 Inducing Apoptosis in Oral Lichen Planus ( A Randomized Controlled Clinical Trial With Immunohistochemical Analysis)
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- clinical score
研究概览
简要总结
tacrolimus has been widely used as an immunosuppressant. the objective of this study was to evaluate the clinical efficacy of tacrolimus 0.1 % in muco adhesive patch compared to tacrolimus or corticosteroids in paste forms for symptomatic oral lichen planus, and to investigate the effect of topical tacrolimus or corticosteroids on the expression of caspase-3 in oral lichen planus as an early marker of apoptosis using immunohistochemically analysis
详细描述
thirty patients with erosive or atrophic OLP were randomly assigned into three equal groups to receive topical steroid ( triamcinolone acetonide 0.1%), four times per day ( Group 1), tacrolimus paste 0.1% four times per day ( Group 2) , and tacrolimus patch 2 times per day ( Group 3). all groups are given treatment for 8 weeks and 4 weeks follow up period without treatment. Photographs of the most severe lesion were taken ( marker lesion ) in each patient and analyzed for total ulcerative area (TUA), total atrophic area (TAA). patients were also assessed using clinical scores (CS) and visual analogue scale (VAS). pre treatment and post treatment specimens were immunohistochemically stained to detect expression of caspase-3.
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
- Single (Outcomes Assessor)
盲法说明
oral lichen planus
入排标准
- 年龄范围
- 25 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •clinically and histologically proven painful bullous/erosive or atrophic forms of OLP
排除标准
- •lichenoid lesions smoking systemic conditions pregnancy or breast feeding known hypersnstivity or severe adverse effects to the treatment drugs or to any ingredient of their preparation
研究组 & 干预措施
tacrolimus/corticosteroid
topical steroids ( triamcinolone acetonide 0.1 %), tacrolimus paste and tacrolimus patch
干预措施: Corticosteroid Topical (Drug)
corticosteroids
topical corticosteroid
干预措施: Corticosteroid Topical (Drug)
tacrolimus
topical tacrolimus patch and tacrolimus paste
干预措施: Corticosteroid Topical (Drug)
结局指标
主要结局
clinical score
时间窗: change from baseline at 12 weeks
"0" represnted no lesion/normal mucosa, "1" mild white stria / no erythematous area
次要结局
- caspase-3(change from base line at 8 weeks)
研究者
Noha Dawoud
assistant lecturer of oral medicine and diagnosis
Ain Shams University