Tolerance and Efficiency of an Intrabuccal Biological Film to Enhance Oral Dryness Sensation: The "PREDELFI" Clinical Pilot Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 10
- 试验地点
- 2
- 主要终点
- Tolerance evaluation
研究概览
简要总结
Xerostomia affects at least a quarter of the population. This prevalence is increased in postmenopausal women and people over 65 years of age. Associated with age are systemic diseases such as Sjögren's Syndrome, diabetes, Parkinson's disease or cancer. It handicaps the patient in his social life, but also in terms of his well-being by the consequences it generates in the oral cavity. This dryness may be the consequence of taking certain medications, head and neck radiotherapy, but also being a symptom of an underlying pathology whose screening will allow early treatment and avoid complications. Today, no single therapeutic solution is enough and patients are waiting for new therapeutic innovations in this area. This study proposes to evaluate the tolerance of an adhesive film containing prebiotics by comparing it to a placebo control film.
详细描述
The purpose of this study is to evaluate the tolerance of an adhesive film containing prebiotics on the improvement of signs and symptoms related to dry mouth by comparing it to a placebo film.
The primary endpoint is the assessment of tolerability assessed using a visual analogue scale (VAS) from 0 to 100 at the end of the 1-month period of both treatment periods (D30 and D90). In this study, the efficacy and tolerance of the adhesive film containing prebiotics will be analyzed.
Each participant in this study will receive two galenic forms of the medical device whose allocation order was previously defined by a randomization list.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Men or women aged 18 or over
- •Complaining of xerostomia and validated by a standardized question
- •With hyposialia diagnosed by the measurement of stimulated salivary flow (DSS) and unstimulated (DNS)
- •Patient having signed a consent
- •Registered with Social Security
排除标准
- •The patient having known sensitivity to any of the products or components of the biofilms (milk protein, soy derivatives, sodium alginate, vegetable glycerin, caramel and beta carotene)
- •Allergic to birch and / or peanut
- •Having an ethyl intoxication (> 2 glasses of wine / day), smoking (> 10 cigarettes / day)
- •Unable to complete self-assessment questionnaires or to follow study protocol procedures (unable to read and / or write).
- •Participant in another clinical study at the time of inclusion or having participated in the 30 days preceding recruitment in this study
- •Having a life-threatening condition for the duration of the study
- •Treated with sialogogues (pilocarpine hydrochloride) within 30 days prior to inclusion
- •Using salivary substitutes
- •Protected persons within the law (articles L1121-5 to L1121-8)
结局指标
主要结局
Tolerance evaluation
时间窗: day 90
The primary endpoint is a composite endpoint of tolerance evaluation defined by: * the patient (EVA from 0 to 100), * the investigator (degree of redness and inflammation of the mucous membranes opposite the site of the device, * reporting adverse events related to the device
次要结局
- Subjective evaluation of dry mouth(day 90)
- Evaluation of salivary flow(day 90)
- Oral comfort(day 90)
- Clinical assessment of the mucous(day 90)
- Evaluation of the salivary microbiota(day 90)