Randomized Controlled Trial of Niacinamide Cosmetic Product Efficacy in Model of Irritant Contact Dermatitis
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- tewameter
研究概览
简要总结
Testing the effectiveness and safety of cosmetics with niacinamide in irritant contact dermatitis: A Randomised, Controlled Trial will be conducted at USSM. Healthy volunteers will be included (at least 25) and test sites are forearms. Sodium lauryl sulphate will be used to induce contact dermatitis and participants will be measured for 7 days
详细描述
The efficacy of niacinamide cosmetic product on contact dermatitis will be evaluated using Courage Khazaka device and probes for hydration, redness and transepidermal water loss
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 50 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •young, healthy volunteers who gave written informed consent
排除标准
- •skin disease, skin damage on measurement sites, use of corticosteroids and immunomodulators a month prior to the inclusion and during the trial, non-adherence to the trial protocol, exposure to artificial UV radiation, pregnancy and lactation
研究组 & 干预措施
placebo
nothing
干预措施: placebo (Other)
intervenition
immortela cosmetic product
干预措施: niacinamide cosmetic product (Other)
结局指标
主要结局
tewameter
时间窗: day 1- day 7
measurement of transepidermal water loss on skin, objective and non invasive
次要结局
未报告次要终点
研究者
Dario Leskur
assistant professor
University of Split, School of Medicine