Phase II Dose-ranging Study of Dentoxol® Mouthrinse for Managing Oral Symptoms in Epidermolysis Bullosa.
试验速览
- 阶段
- 2 期
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Change in oral symptoms associated to oral bullae, erosions and ulcerations in adults and children over the age of 6 living with Epidermolysis Bullosa with two different dose regimes of Dentoxol® mouthrinse and compare both effects.
研究概览
简要总结
Inherited Epidermolysis Bullosa (EB) is a disorder that causes skin fragility and blistering in skin and mucous membranes, including the mouth. Recurrent oral blisters and ulcer result in oral pain and discomfort.
Dentoxol® is a mouthrinse that has anti-inflammatory, antimicrobial and analgesic effects. It has significant potential to reduce EB related oral symptoms.
This study includes people living with Inherited Epidermolysis Bullosa aged 6 and above; and is aimed at determining the efficacy of two different dose regimens of Dentoxol mouthrinse in reducing oral symptoms.
详细描述
Inherited Epidermolysis Bullosa (EB) is a group of genetic disorders with skin fragility and blistering. In addition to the skin, it can affect the mucous membranes, causing oral symptoms including oral pain and discomfort due to recurrent oral blisters, ulcers and erosions. Dentoxol® is a proprietary mouthrinse that has anti-inflammatory, antimicrobial and analgesic effects. This three-pronged strategy therefore has significant potential to reduce EB related oral symptoms.
Preliminary reports of Dentoxol® mouthrinse have suggested that it is safe and effective in reducing the EB related oral symptoms.Therefore, a well-controlled Phase II study is now warranted.
This study will include people living with Inherited Epidermolysis Bullosa aged 6 and over, and seeks to determinate the efficacy of two different dose regimens of Dentoxol mouthrinse in reducing the symptoms mentioned above.
Methods: 100 subjects with EB will be recruited and will be given Dentoxol® mouthrinse for two periods of 6 weeks using different dose regimes.
Subjects will have a dose regimen assigned randomly, group A: first 6 weeks will be asked to rinse 5 times a day, followed by a 4 weeks washout period and the second 6 weeks period: twice a day. Group B: first 6 weeks 2 times a day, second 6 weeks period: 5 times a day, both with a 4 week washout period in between.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Supportive Care
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •People living with Inherited Epidermolysis Bullosa, including all types and subtypes, registered at Debra Foundation at the country of the study.
排除标准
- •Unable to give written informed consent / assent.
- •Have used a mouth rinse aimed at managing oral ulcers in the last 4 weeks.
- •Known allergy/intolerance to any component of the study rinse.
- •Planning to use any of the following contraindicated medications during the study period (pain medications are allowed)
- •Any agent marketed for oral mucositis
- •Antibiotics (eg, tetracyclines) (Note: topical antifungals are allowed)
- •Povidone iodine
- •Sucralfate and other coating agents such as Gelclair, MuGard, etc.
- •Chlorhexidine Gluconate (Oralgene, Perioaid, Peridex, Periogard)
- •Diphenhydramine (Benadryl)
- •Laser therapy for oral mucositis
- •Any other anti-inflammatory agent
- •Any other investigative agent
- •*Note: "Miracle / Magic" rinse preparations containing viscous lidocaine are allowed, however, diphenhydramine and other excluded agents should not be added.
- •Age below 6 years
- •Pregnant or nursing
- •Unable to rinse the mouth due to limited oral functioning.
结局指标
主要结局
Change in oral symptoms associated to oral bullae, erosions and ulcerations in adults and children over the age of 6 living with Epidermolysis Bullosa with two different dose regimes of Dentoxol® mouthrinse and compare both effects.
时间窗: 16 weeks
Epidermolysis Bullosa Oral Health Questionnaire (EBOHQ)
次要结局
- Change in the number of the lesions with two different dose regimes of Dentoxol® mouthrinse and compare both effects.(16 weeks)
- Change in the distribution of the lesions with two different dose regimes of Dentoxol® mouthrinse and compare both effects.(16 weeks)
- Change in oral pain with two different dose regimes of Dentoxol® mouthrinse and compare both effects.(16 weeks)
- Improve the oral health related quality of life and oral functioning with two different dose regimes of Dentoxol® mouthrinse and compare both effects.(16 weeks)
- Change in the duration of the lesions with two different dose regimes of Dentoxol® mouthrinse and compare both effects.(16 weeks)
- Change in the recurrence of the lesions with two different dose regimes of Dentoxol® mouthrinse and compare both effects.(16 weeks)
- Change in the size of the lesions with two different dose regimes of Dentoxol® mouthrinse and compare both effects.(16 weeks)
- Patients acceptance of mouthrinse use(16 weeks)
- Change in the frequency of the lesions with two different dose regimes of Dentoxol® mouthrinse and compare both effects.(16 weeks)
- Patients compliance with treatment.(16 weeks)
研究者
Susanne Kramer
Associate Professor
University of Chile