Intense Pulsed Light as an Adjunctive to Bromonidine for the Treatment of Rosacea- a Prospective Study
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 试验地点
- 1
- 主要终点
- patient self-assessment questionaires score change
研究概览
简要总结
This is an interventional and prospective study. The study is designed to evaluate the additional benefits of a combination of IPL treatment and local application of Bromonide 0.33% gel in the treatment of erythematotelangiectatic (ETR) and papulopustular (PPR).
详细描述
Patients would be treated with full face application of bromonide 0.33% gel once daily for three months. In addition half of the patients' face would be subjected to three IPL treatment sessions three weeks apart from each other.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
盲法说明
Physicians will perform assessment of clinical outcome, using clinical photographs .These physicians will be blinded to which half of the face was treated with intense pulsed light.
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
- •patient (male or female) must be over 18 yaers old of age and fulfil one of the following:
- •Suffer from ETR
- •Suffer from PPR
- •Suffer from a combination of ETR and PPR.
排除标准
- •1.Under 18 years old of age. 2.Pregnant women. 3.Systemic treatment of rosacea at the previous six months before enrollment. 4.Topical treatment of rosacea at the previous one month before enrollment. 5.Phymatous or occular rosacae.
研究组 & 干预措施
Treatment with bromonide 0.33% gel
Patients would be treated with full face application of bromonide 0.33% gel once daily for three months. Half of the patients' face would recieve this treatment alone.
干预措施: Bromonide 0.33% gel (Drug)
Treatment with bromonide 0.33% gel & IPL
Patients would be treated with full face application of bromonide 0.33% gel once daily for three months. Half of the patients' face would be subjected to three IPL treatment sessions three weeks apart from each other.
干预措施: Bromonide 0.33% gel (Drug)
Treatment with bromonide 0.33% gel & IPL
Patients would be treated with full face application of bromonide 0.33% gel once daily for three months. Half of the patients' face would be subjected to three IPL treatment sessions three weeks apart from each other.
干预措施: Intense Pulsed Light (M22) (Device)
结局指标
主要结局
patient self-assessment questionaires score change
时间窗: six months after initiation of treatment compared to Baseline
Patient will assess disease change on 5 points scale (0=no improvement, 1=0-25% improvement, 2=26-49% improvement, 3=50-74% improvement, 4= 75-100% improvement.
Physicians' unblinded score assessment
时间窗: six months after initiation of treatment compared to Baseline
Physician will assess disease change on 5 points scale (0=no improvement, 1=0-25% improvement, 2=26-49% improvement, 3=50-74% improvement, 4= 75-100% improvement.
次要结局
未报告次要终点