NCT01429701已完成3 期
Unicentric Comparing Effectiveness of Polymyxin B Sulphate + Prednisolone + Benzocaine + Clioquinol to Betamethasone + Gentamicin + Tolnaftate + Clioquinol in Acute and Sub-acute Dermatitis Eczematous
EMS0 个研究点目标入组 76 人开始时间: 2012年5月最近更新:
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 76
- 主要终点
- Reduction / improvement of signs and symptoms
研究概览
简要总结
Dermatitis eczematous is a recurrent pruritic skin disorder which has a significant morbidity and impaired quality of life due specially pruritus and physical visible skin lesions. The purpose of this trial is evaluate the effectiveness of two different topic associations of drugs.
详细描述
Study design:
- Experiment duration: 22 days
- 2 visits (days 0,7,15 and 22)
- Reducing eczema area and severity index evaluation
- Adverse events evaluation
- Double blinded, non-inferiority, prospective parallel-group, intend to treat trial.
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 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients must be able to understand the study procedures agree to participate and give written consent.
- •Patients with acute or subacute dermatitis with a minimum of 3 symptoms.
排除标准
- •Pregnancy or risk of pregnancy.
- •Use of anti-inflammatory or immunosuppressive drugs (last 30 days prior to the study).
- •Sunlight over exposure in the last 15 days.
- •Any pathology or past medical condition that can interfere with this protocol.
研究组 & 干预措施
Test association cream
Experimental
polymyxin B sulphate + prednisolone + benzocaine + clioquinol
干预措施: polymyxin B sulphate + prednisolone + benzocaine + clioquinol (Drug)
Comparative association cream
Active Comparator
betamethasone + gentamicin + tolnaftato + clioquinol
干预措施: betamethasone + gentamicin + tolnaftato + cleoquinol (Drug)
结局指标
主要结局
Reduction / improvement of signs and symptoms
时间窗: DAY 22
The reduction of signs and symptoms will be evaluated by OSAAD index.
次要结局
- Adverse Events Evaluation(DAY 22)
研究者
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