NCT01257061已完成3 期
Unicentric Comparing Effectiveness Superiority of to Clemastine Fumarate 1, 0 mg/g + Dexamethasone 0, 5 mg/g to Dexchlorpheniramine Maleate 10 mg/g in Eczema Treatment.
EMS1 个研究点 分布在 1 个国家目标入组 310 人开始时间: 2012年9月6日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 310
- 试验地点
- 1
- 主要终点
- Reduction / improvement of signs and symptoms
研究概览
简要总结
Atopic dermatitis 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 propose of this trial is evaluate the effectiveness of clemastine fumarate 1, 0 mg/g + dexamethasone 0, 5 mg/g compared to dexchlorpheniramine maleate 10 mg/g in eczema treatment.
详细描述
Study design:
• Double blinded, superiority, prospective parallel-group, intend to treat trial.
Study design:
- Experiment duration: 22 days
- 2 visits (days 1,7,15 and 22)
- Reducing Eczema Area and severity index evaluation
- Adverse events evaluation
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 5 Years 至 50 Years（Child, 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 sub-acute eczema.
- •Presence of symmetric lesions to compare on side to the other.
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
Group 1
Experimental
Clemastine fumarate 1,0 mg/g + dexamethasone 0,5/g
干预措施: Group 1 (Drug)
Group 2
Active Comparator
Dexchlorpheniramine maleate 10 mg/g
干预措施: Group 2 (Drug)
结局指标
主要结局
Reduction / improvement of signs and symptoms
时间窗: DAY 22
The reduction of signs an symptoms will be evaluated by OSAAD index.
次要结局
- Adverse Events Evaluation(DAY 22)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
2 期
A Comparative Clinical Trial Evaluating the Effect and Safety of Tacrolimus Versus HydrocortisoneDermatologic DiseaseNCT05607901Tanta University100
已完成
4 期
Tacrolimus Versus Hydrocortisone in Atopic DermatitisAtopicDermatitisNCT05324618Ain Shams University200
Unknown
不适用
Efficacy of Combining Topical Antibiotic/Steroid/Moisturizer Therapy Compared to Active Comparator in Atopic Dermatitis.Severe Atopic DermatitisNCT03052348Red Cross War Memorial Childrens Hospital78
已完成
不适用
Prospective, Randomized, Double Blind Comparative Study on the Use of Two Creams in Xerosis Atopic ProbandsAtopic DermatitisNCT00509535L'Oreal75
已完成
2 期
Efficacy and Safety of a a Biofunctional Textile in the Management of Atopic DermatitisAtopic DermatitisNCT01597817Universidade do Porto78