NCT01792713已完成2 期
Randomisierte, Doppelblinde, Plazebo-kontrollierte Prüfung Zum Nachweis Der Wirksamkeit Und Der Lokalen Verträglichkeit Einer 2%Igen Sertaconazol-Crème Bei Patienten Mit Atopischer Dermatitis (Abridged)
Spirig Pharma Ltd.2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2013年2月最近更新:
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
- 入组人数
- 70
- 试验地点
- 2
- 主要终点
- Change in Patient Global Assessment (PGA)
研究概览
简要总结
Investigation aimed to explore the efficacy of a topical Sertaconazole cream 2% in patients with skin alterations associated with atopic 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent
- •Atopic Dermatitis Patients with SCORing Atopic Dermatitis (SCORAD) ≤ 40
- •Atopic lesion localisation: arms; additional legs, neck
排除标准
- •SCORAD > 40
- •Unstable, uncontrolled medical status (e.g. active systemic or topical infection)
- •Active immunosuppression or cancer
- •Narcotics- or Alcohol abuse
- •Participation in another clinical trial until one month prior inclusion
- •Known allergies against an ingredient of the investigational medicinal product
- •Different periods of grace for certain pre-treatments, e.g. topical corticosteroids, immune modulating drugs
- •Pregnancy or lactation
研究组 & 干预措施
Sertaconazole 2% cream
Active Comparator
2x daily treatment with Sertaconazole 2% cream for 4 weeks, 2 weeks follow-up
干预措施: Sertaconazole 2% cream (Drug)
Placebo Arm
Placebo Comparator
2x daily treatment with Placebo cream for 4 weeks, 2 weeks follow-up
干预措施: Placebo (Drug)
结局指标
主要结局
Change in Patient Global Assessment (PGA)
时间窗: day 1, day 28
次要结局
- Change in Eczema Area and Severity Index (EASI)(day 1, day 28)
- Change in Dermatology Life Quality Index (DLQI)(d1, d28)
- Change in Patient Benefit Index (PBI)(day 1, day 28)
研究者
研究点 (2)
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