A Randomized, Controlled Clinical Trial of M89PF in Rosacea Associated With Erythema and Sensitive Skin
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- transepidermal water loss
研究概览
简要总结
Rosacea is a common facial dermatosis, with flares induced by exposome factors. M89PF containing Vichy mineralizing water, probiotic fractions, hyaluronic acid, niacinamide and tocopherol repairs the skin barrier and reinforces skin defences against exposome factors.
This study assessed the benefit of M89PF in patients with rosacea associated with erythema and sensitive skin during the Covid-19 pandemic with use of protective face masks.
详细描述
M89PF was compared to usual skin care in a randomized, split-face study, for 30 days in subjects with rosacea associated with erythema and sensitive skin. Clinical evaluations included erythema, desquamation, skin tightness, dryness, burning sensation, itching, stinging, stinging test, and local tolerability. Instrument evaluations included erythema, skin hydration and TEWL. Subject satisfaction was also assessed.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adult subjects with rosacea associated with erythema and less than 3 papules or pustules and having sensitive skin (positive 15% lactic acid sting test)
排除标准
- 未提供
结局指标
主要结局
transepidermal water loss
时间窗: Day 30
tewameter
erythema
时间窗: Day 30
assessment using a chromameter
skin hydration
时间窗: Day 30
using a corneometer
次要结局
- Demodex density(Day 30)
- clinical symptoms (skin tightness, dryness, burning sensation, itching and stinging)(Day 30)
- skin sensitivity(Day 30)
- local tolerability(Day 30)
- subject satisfaction(Day 30)