Evaluation of the Efficacy of 0.08% Tacrolimus Nanoencapsulated Aqueous Solution Spray Vs. 0.1% Free Tacrolimus Commercial Ointment in the Treatment of Oral Lichen Planus - a Randomized Clinical Trial
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 46
- 试验地点
- 1
- 主要终点
- Oral Disease Severity Score (ODSS) - 50%
研究概览
简要总结
The goal of this clinical trial is to assess the efficacy of different formulations of the drug tacrolimus in treating patients with oral lichen planus. The main questions it aims to answer are:
- Does the nanoencapsulation of tacrolimus in an aqueous solution, used as a spray, improve the effectiveness of treating oral lichen planus lesions compared to the commercially available tacrolimus ointment?
- Which tacrolimus formulation can keep participants free of lesions for longer periods?
Researchers will compare a spray of 0.08% tacrolimus nanoencapsulated aqueous solution against a 0.1% free tacrolimus commercial ointment to determine which formulation is more effective.
Participants will:
- Apply one of the proposed tacrolimus formulations twice a day for 1 month.
- Visit the clinic once every 2 weeks for checkups and tests, with follow-ups extending up to 3 months.
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)
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
- •individuals with a clinical and histopathological diagnosis of erosive/ulcerative/atrophic and symptomatic oral lichen planus, according to the criteria established by the American Academy of Oral and Maxillofacial Pathology
排除标准
- •History of oral cancer;
- •history of allergic reactions to tacrolimus or any other component of the formulas;
- •history of organ transplant or have a systemic condition that induces significant immunosuppression;
- •be pregnant or lactating.
研究组 & 干预措施
0.08% tacrolimus nanoencapsulated aqueous solution spray
tacrolimus modified-release
干预措施: Tacrolimus modified-release (Drug)
0.1% free tacrolimus commercial ointment
干预措施: tacrolimus ointment 0.1% (Drug)
结局指标
主要结局
Oral Disease Severity Score (ODSS) - 50%
时间窗: 30 days
Number of patients achieving a reduction of at least 50% in ODSS score compared to baseline and the percentage and absolute reduction in ODSS score in both groups at the end of treatment (30 days). ODSS score ranges from 0 to 106, lower score mean a better outcome.
VAS (visual analogical score) pain score - 50%
时间窗: 30 days
number of patients achieving a reduction of at least 50% in VAS score of reported pain compared to baseline and the percentage and absolute reduction in VAS score in both groups at the end of treatment (30 days). VAS score ranges from 0 to 10, lower score mean a better outcome.
次要结局
- OHIP-14 quality of life score(15-90 days)
- Beck scale scores (anxiety levels)(15-90 days)
- hedonic scale satisfaction scores(30-90 days)