Clinical Evaluation of a Hyaluronic Acid-based Medical Device in Counteracting Aphthous Stomatitis in Adults
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 49
- 试验地点
- 1
- 主要终点
- Change in number of oral lesions
研究概览
简要总结
Oral mucosal ulcers can determine a real worsening of the quality of life. Conventional therapy usually lasts not less than 2-3 weeks, and carries a high risk of serious side effects; furthermore, ulcers often recur. The use of hyaluronic acid applied as an adhesive gel over the lesions seems to have potential in terms of efficacy and the avoidance of side effects. Of course, hyaluronic acid-based formulations show different effects and tolerability. In this retrospective observational study, the results obtained using a hyaluronic-acid based medical device applied for 14 days to counteract ulcers in adults will be reported.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of aphthous stomatitis
- •Healthy for other conditions excluding aphthous stomatitis
排除标准
- •Taking one of the following in the 45 days prior to the beginning of the study: immunosuppressive, cytotoxic, cortisone, antibiotic, antifungal, hormone therapy (including birth control pills).
研究组 & 干预措施
Chlorhexidine gluconate
Chlorhexidine gluconate at a concentration of 0.2%.
干预措施: Chlorhexidine Gluconate (Drug)
Hyaluronic acid-based gel
The composition of the gel, ranked by weight is: xylitol, glycerin, Rosa damascena petal extract, xanthan gum, polycarbophil, hyaluronic acid sodium salt (0.24%), pectin, potassium sorbate, sodium benzoate, panthenol, Aloe barbadensis leaf extract, stevia.
干预措施: Hyaluronic acid-based gel (Device)
结局指标
主要结局
Change in number of oral lesions
时间窗: Day 1; Day 3; Day 6; Day 9; Day 12; Day 14
Change from baseline (Day 1) to Day 14 in the number of oral lesions observed in the two groups
Change in size of oral lesions
时间窗: Day 1; Day 3; Day 6; Day 9; Day 12; Day 14
Change from baseline (Day 1) to Day 14 in the size (mm) of oral lesions observed in the two groups
次要结局
- Side effects to treatment(From Day 1 to Day 14)
- Compliance to treatment(From Day 1 to Day 14)
研究者
Davide Sisti
PhD
University of Urbino "Carlo Bo"