Open Label Split Face Pilot Study to Assess the Safety and Efficacy of Cold Atmospheric Plasma (Non-thermal Plasma) for the Treatment of Rosacea
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 试验地点
- 2
- 主要终点
- Efficacy - Investigator global assessment
研究概览
简要总结
10-13 patients will be enrolled to receive split face treatment: the control side will be treated with metronidazole cream, the intervention side will be treated with a cold atmospheric plasma device
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
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
- •Papulopustular rosacea of the cheeks
- •Ability to complete six weeks of twice-weekly treatments
排除标准
- •substantial asymmetry of disease distribution
- •previous failure of topical ivermectin treatment
- •presence of any other facial dermatoses
- •presence of any photosensitizing disorders
- •systemic tetracycline, systemic or topical ivermectin treatment within 6 weeks of start date
- •current or within prior 3 months treatment with systemic immune-suppressive medication
结局指标
主要结局
Efficacy - Investigator global assessment
时间窗: 6 weeks
Rosacea improvement will be evaluated based on clinical photos (worsened, unchanged, mild improvement, substantial improvement, cleared)
RosaQoL change
时间窗: 6 weeks
Rosacea Quality of Life tool: 5-point scale Ranging from 1 (no impact) to 5 (worst impact)
Demodex count change
时间窗: 6 weeks
Change in demodex folliculorum mite density, measured by Reflectance Confocal Microscopy )number of follicles with mite, total number of mites in measured area, number of mites per follicle)
Efficacy - National Rosace Society Expert Committee grading system
时间窗: 6 weeks
Complex scoring system as described by Wilkin et al, J Am Acad Dermatol 2004;50:907-12
次要结局
- Tolerability - Incidence of Treatment-Emergent Adverse Events as assessed by patient review(6 weeks)
- Tolerability - pain as assessed by NRS scale(6 weeks)