Double Blinded Randomized Clinical Study of Carbamide as Moisturizer in Ichthyosis Vulgaris
试验速览
- 阶段
- 不适用
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Skin dryness
研究概览
简要总结
A randomized double blinded clinical trial will be conducted comparing the effect of two simple basic moisturizers only different in the concentration of carbamide (urea). The concentrations of carbamide will be tested are 0 and 7.5, respectively. The study will be conducted as a split-body-study and will contain two arms randomized to comparing 0 and 7.5 % carbamide, respectively. Approximately 20 patients with at least clinically verified Ichthyosis Vulgaris will be enrolled to each study arm. The effect of the moisturizers will be assessed by clinical examination (score), patients assesment of effect and measurement of transepidermal water loss (TEWL) and other skin parameters.
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
- Double (Participant, Investigator)
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinically diagnosed with Ichthyosis Vulgaris
排除标准
- •All other forms of Ichthyosis
研究组 & 干预措施
Only moisturizer, no carbamide
20 patients with Ichthyosis Vulgaris at age 0-80 years old. One body half
Moisturizer + 7,5 % carbamide
20 patients with Ichthyosis Vulgaris at age 0-80 years old. Other body half
干预措施: 7.5 % (Device)
结局指标
主要结局
Skin dryness
时间窗: 2-8 weeks
Transepidermal water loss ('TEWL) (g/m2/h)
次要结局
未报告次要终点