Study of Topical Preparation of Capsaicin Nanoparticle in Patient With Painful Diabetic Neuropathy
试验速览
- 阶段
- 2 期
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Pain relief from pain score reduction, using visual analog scale (VAS)
研究概览
简要总结
The objectives of this study are to determine efficacy and safety of 0.75% topical capsaicin nanoparticle preparation versus placebo in patient with painful diabetic neuropathy.
详细描述
Painful diabetic neuropathy is the most common cause of neuropathic pain. 0.075% topical capsaicin has been used to treat the pain. Because of high concentration, conventional capsaicin topical preparation causing burning sensation and required several time of applications per day.
The nanoparticle of capsaicin topical preparation was developed with expectation of remaining efficacy, minimizing burning sensation and improving convenience of use.
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
- Quadruple (Participant, Care Provider, Investigator, 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
- •History of type 2 Diabetes mellitus
- •Peripheral neuropathy
- •Stabilized on pain medication for at least one month
- •No previous invasive intervention for pain relief
排除标准
- •Local wound or any skin abnormality in the applicable area
- •Allergic to capsaicin
- •Refuse to participate or give consent
- •Has other significant disease or receive medication that may worsen neuropathy
研究组 & 干预措施
Placebo
Matched gel base of capsaicin nanoparticle
干预措施: Placebo (Drug)
Capsaicin
0.075% capsaicin nanoparticle gel
干预措施: 0.75% capsaicin nanoparticle cream (Drug)
结局指标
主要结局
Pain relief from pain score reduction, using visual analog scale (VAS)
时间窗: 12 weeks
次要结局
未报告次要终点
研究者
Pongsatorn Meesawatsom
Mr.
Mahidol University