A 4 Week Randomized Double-blind Parallel Group Active Comparator Controlled Study of Elidel (Pimecrolimus) for the Treatment of Seborrheic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 113
- 试验地点
- 1
- 主要终点
- The Change of F-IGA From Baseline (BL) to wk 1 Will be the Primary Efficacy Variable.
研究概览
简要总结
This is an exploratory study to determine effectiveness of Elidel for the treatment of seborrheic dermatitis
详细描述
This is a 4 week study for patients 18 and older to compare the efficacy and safety of pimecrolimus cream 1% twice daily and ketaconazole cream 2 % twice daily for the treatment of seborrheic dermatitis.
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 (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Must be 18 or older and sign written informed consent.
- •Must be wiling and able to comply with protocol.
- •Must have active seborrheic dermatitis of the face.
排除标准
- •No history of overt bacterial, viral or fungal infection of the head/neck.
- •No history or presence of compromising dermatosis elsewhere on the skin
- •No Parkinson's disease, HIV, infections or disorders of the central nervous system
- •No actinically damaged skin
研究组 & 干预措施
Elidel Cream (pimecrolimus)
Elidel Cream to be applied twice daily for 4 weeks
干预措施: Elidel (Drug)
Ketoconazole Cream (Nizoral)
Ketoconazole Cream to be applied twice daily for 4 weeks
干预措施: Ketoconazole Cream (Drug)
结局指标
主要结局
The Change of F-IGA From Baseline (BL) to wk 1 Will be the Primary Efficacy Variable.
时间窗: One week from Baseline
F-IGA is defined as Facial Investigator's Global Assessment, which incorporates assessments of the severity of facial seborrheic dermatitis. Scoring is 0 to 3, 0 describing a better outcome with progressively worsening up to 3 representing a worse outcome (whole number only). 0 = Clear; 1 = Mild; 2 = Moderate and 3 = Severe. Scoring is based upon morphologic description of signs of erythema (0 =none, 1= faint, 2 =dull, 3 =deep/dark red) and scaling (0 = none, 1 = minute, powdery scale, 2 = thin flakes of scale, 3 = scales covering most of the involved areas).
次要结局
- Key Secondary Efficacy Will be the % of Patients With Facial Clearance(4 weeks)