Beneficial Effects of Paraffin Bath Therapy as Additional Treatment of Chronic Hand Eczema: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- SCORAD ("SCORing Atopic Dermatitis
研究概览
简要总结
Objective: Chronic Hand eczema (CHE) is a common inflammatory skin disease has a major medical psychological and socio-economic implications that affect quality of life (QoL)and work ability. This study, the first randomized controlled trial that will be conducted to evaluate the effect of paraffin bath therapy (PBT) in the treatment of CHE.
详细描述
Design: The study design is a randomized controlled trial with measures at pre-and post-intervention.
Subjects: Sixty patients with moderate to severe Chronic Hand eczema (CHE) will participate in the study. They will be classified randomly into two groups of equal number; paraffin group and the control group.
Interventions: Paraffin group will receive Paraffin bath therapy for 5 days per week for 12 weeks in addition to routine skin care program while the control group will receive routine skin care program.
Outcome Measures:
Objective SCORing Atopic Dermatitis, subjective item score and dermatology life quality index (DLQI) will be assessed before, at 6th week and at 12th week of treatment.
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
- Single (Outcomes Assessor)
盲法说明
Measurements will be at three occasions: at randomization (T1), at 6th week (T2) and at 12th week (T3) of treatment. Evaluative procedures will be by a blind assessor
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age from 20-40 years
- •Time elapsed from the beginning of the disease ; more than three months according to the Guideline of the German Dermatological Society
排除标准
- •active eczematous lesions on other parts of the body;
- •malignant or premalignant skin tumors
结局指标
主要结局
SCORAD ("SCORing Atopic Dermatitis
时间窗: Change from Baseline at SCORAD score at 6th week and at 12th weeks of treatment
is the most widely clinical tool for assessing the severity (i.e. extent, intensity) of atopic dermatitis as objectively as possible.20 It consists of six objective items (erythema, oedema/papules, effect of scratching, oozing/crust formation, lichenification, and dryness), and two subjective symptoms (itch and sleeplessness), the maximum score is 103 points
次要结局
- Dermatology life quality index (DLQI)(Change from Baseline at 6th week and at 12th weeks of treatment)
研究者
ZIZI MOHAMMED IBRAHIM ALI
ASSOCIATE PROF
Cairo University