Azelaic Acid Iontophoresis Versus Topical Azelaic Acid Cream in the Treatment of Melasma - An Open Randomized, Controlled, Prospective, Single Blinded Clinical Trial
试验速览
- 阶段
- 2 期
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Change in colorimetric measurement of skin colour and MASI-Score after 12 weeks of treatment
研究概览
简要总结
The purpose of this prospective, randomized, controlled, single-blinded investigation is to study the efficacy, tolerability and safety of azelaic acid iontophoresis (AAI) versus topical treatment with azelaic acid cream in female patients with melasma.
详细描述
Patients will be randomized and allocated in concealed manner to one of the two treatment arms: AAI or topical azelaic acid cream.
Azelaic acid iontophoresis treatment schedule:
Patients randomized to the AAI group will receive iontophoresis with 15% azelaic acid twice weekly over a period of 12 weeks.
Azelaic acid topical treatment schedule:
Patients randomized to the topical treatment group will receive topical treatment with 20% azelaic acid cream twice daily over a period of 12 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •MASI - Score over 6
- •Age: over 18 years
- •Skin Type: III, IV, V
排除标准
- •Skin Type: I, II, VI
- •Pregnant or lactating women
- •Local therapy of intent-to-treat area within the last 6 month
- •Patient with a pacemaker or metal implant
- •Epileptic
- •Mental incompetence to understand the protocol
- •Known allergic reactions to one of used substances
- •Serious encroachment on physical condition
结局指标
主要结局
Change in colorimetric measurement of skin colour and MASI-Score after 12 weeks of treatment
时间窗: 3 month
次要结局
- Physician Global Assessment, Patient Global Assessment, Overall Response Assessment(3 month)