Impact of the Efficacy of Fluocinonide 0.05% Oral Gel in the Treatment of Oral Lichen Planus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Assessment of sings
研究概览
简要总结
A double-blind placebo-controlled trial is conducted in order to evaluate the efficacy of Fluocinonide 0,05% and determinate the statistical significance of the outcome variables. Oral cavity lichen is a chronic inflammatory condition affecting the mucosa of the oral cavity , which significantly reduces the quality of life of affected individuals.
详细描述
A double-blind placebo-controlled study was conducted to evaluate the clinical efficacy of Fluocinonide 0.05% oral gel and determine the statistical significance of outcome variables.
20 patients with Oral Lichen Planus were divided by a randomization system, into two groups: case group treated with Fluocinonide 0.05% oral gel and applied to oral lesions 2 times a day for 1 month and a placebo group as a control group; with 2 months of follow-up.
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, Investigator)
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
- •Clinical and histologic diagnosis of Lichen Planus Orale;
- •Presence of symptoms related to Lichen Planus Orale;
- •Clinical follow-up period of at least 12 weeks;
- •Acceptance of informed consent
排除标准
- •State of pregnancy or lactation; h
- •Histologic signs of dysplasia;
- •Medications that induce a lichenoid response (ACE inhibitors, β-blockers, etc.);
- •Presence of amalgam fillings in the vicinity of lesions;
- •Treatment of oral lichen in the previous 6 months from the start of the program;
- •Presence of extraoral lesions (genital, skin, etc.);
- •Diabetes being treated with oral hypoglycemic drugs;
- •History of previous immunodeficiency;
- •HIV seropositivity;
- •Previous allogeneic bone marrow transplantation;
- •Diagnosis of LES or other autoimmune disease
研究组 & 干预措施
Active Comparator: Fluocinonide 0,,05% oral gel
Patients were treated with a topical gel of Fluocinonide 0.05%, applied to oral lesions twice daily for 1 month.
干预措施: Fluocinonide 0,05% oral gel (Drug)
Placebo Comparator: Placebo
Patients were treated with a topical gel of placebo, applied to oral lesions twice daily for 1 month.
干预措施: Placebo (Drug)
结局指标
主要结局
Assessment of sings
时间窗: 3 months
Assessment of sings using the Thongprasom scoring system at baseline and after 2 months
次要结局
- Assessment of symptoms(3 months)
研究者
Gaetano Isola
Researcher
University of Catania