NCT00408330已完成2 期
A Double-Blind, Randomized, Vehicle-Controlled, Six-Week Exploratory Multicenter Pilot Study of the Efficacy and Safety of Azelaic Acid (AzA) 15% Gel in the Topical Treatment of Mild to Moderate Seborrheic Dermatitis of the Face
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 48
- 主要终点
- Sum Score of the symptoms of seborrheic dermatitis and the investigator's global assessment.
研究概览
简要总结
This study is to determine whether a medication on the market for other indications is effective and safe in treating seborrheic dermatitis of the face.
详细描述
To test the efficacy and safety of azelaic acid 15% gel in the treatment of seborrheic dermatitis of the face
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
- Double (Participant, Investigator)
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
- •Stable or exacerbating seborrheic dermatitis in the facial area
排除标准
- •Psoriasis
- •Atopic dermatitis
- •Facial acne and rosacea
- •Dermatophytic skin infections
- •Parkinson's disease
- •Known immunosuppression; HIV infection
- •Any condition requiring continuous systemic or topical corticosteroid or antimycotic therapy
- •Continuous asthma inhalation treatment requiring > 800 mg corticosteroids
- •Any severe disease likely to interfere with the conduct or the planned termination of the study
研究组 & 干预措施
1
Active Comparator
azelaic acid 15%
干预措施: Azelaic Acid 15% Gel (Drug)
2
Placebo Comparator
Inactive 15% gel base
干预措施: Inactive 15% gel base (Drug)
结局指标
主要结局
Sum Score of the symptoms of seborrheic dermatitis and the investigator's global assessment.
时间窗: Measurement of parameters during the course of treatment (six weeks)
次要结局
- Investigators' and patients' subjective assessment of improvement; frequency and intensity of single symptoms(Measurement of parameters during the course of treatment (six weeks))
研究者
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