Phototherpy Versus Tap Water Iontophoresis for Management of Atopic Dermatitis in Children, Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Patient Oriented Eczema Measure" POEM"
研究概览
简要总结
this study is conducted to compare the effect of phototherapy" psoralen plus UVA " bath puva to tap water iontophoresis in the treatment of atopic dermatitis in children.
详细描述
Sixty children were selected from the department of dermatology, Banha University Hospital. Patients were randomly assigned to (Group- A):- 20 children Patients, aged between 6-16 years old. be treated with Phototherapy, for 3 sessions per week for 8 weeks Plus the traditional medical treatment. which is the betamethasone dipropionate 0.05% " diprolene for 2 times a day for 8 weeks. (Group B): 20 children Patients, in Group-B are treated with tap water iontophoresis, for 8 weeks, 3 sessions /week: the intensity were increased according to the patient's tolerance, for 20 minutes. Plus the traditional medical treatment. (Group -C) the control group will treated by only the traditional medical treatment which is the betamethasone dipropionate 0.05% " diprolene" cream, two times a day for 8 weeks Skin thickness by ultrasonography and Patient Oriented Eczema Measure(POEM) are measured before and after 8 weeks 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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 9 Years 至 16 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age between 9 to 16 years.
- •Suffering from AD of dyshidrotic as well as dry types of more than 6-months duration
- •Traditional types of treatment options, including oral or topical corticosteroids, proved ineffective.
排除标准
- •Intolerance history to UV radiation.
- •Skin malignancy at the area to be treated.
- •Acute infection at the treated area.
- •Children received radiotherapy in the area to be treated during the last 6 months.
- •Children received corticosteroid therapy topically within 14 days before treatment, or systemic corticosteroids or any immunosuppressive drugs within the last 4 weeks.
- •Circulatory and sensory disorders and children with diabetes mellitus.
研究组 & 干预措施
Phototherapy "PUVA" +traditional medical treatmentn
patient sock his hands in a bath containing water with the constitution of psoralen "meladinine " capsule for 20 minutes then irradiated at the UVA device for 3 sessions per week for 8 weeks Plus the traditional medical treatment. which is the betamethasone dipropionate 0.05% " diprolene for 2 times a day for 8 weeks.
干预措施: Ultra Violet A Device.+ Topical medical treatment (Device)
Phototherapy "PUVA" +traditional medical treatmentn
patient sock his hands in a bath containing water with the constitution of psoralen "meladinine " capsule for 20 minutes then irradiated at the UVA device for 3 sessions per week for 8 weeks Plus the traditional medical treatment. which is the betamethasone dipropionate 0.05% " diprolene for 2 times a day for 8 weeks.
干预措施: Topical medical treatment (Betamethasone dipropionate 0.05% " diprolene " ) (Drug)
Tap Water Iontophoresis + Traditional medical treatment
Tap-water iontophoresis was given 3 times weekly for 10 min The direct current level was slowly increased, guided by the occurrence of tingling sensations. The maximum level was 30mA. Plus the traditional medical treatment. which is the betamethasone dipropionate 0.05% " diprolene for 2 times a day for 8 weeks.
干预措施: Iontophoresis device + Topical medical treatment (Device)
Tap Water Iontophoresis + Traditional medical treatment
Tap-water iontophoresis was given 3 times weekly for 10 min The direct current level was slowly increased, guided by the occurrence of tingling sensations. The maximum level was 30mA. Plus the traditional medical treatment. which is the betamethasone dipropionate 0.05% " diprolene for 2 times a day for 8 weeks.
干预措施: Topical medical treatment (Betamethasone dipropionate 0.05% " diprolene " ) (Drug)
traditional medical treatment
Traditional medical treatment. which is the betamethasone dipropionate 0.05% " diprolene for 2 times a day for 8 weeks.
干预措施: Topical medical treatment (Betamethasone dipropionate 0.05% " diprolene " ) (Drug)
结局指标
主要结局
Patient Oriented Eczema Measure" POEM"
时间窗: 8 weeks of treatment
The severity of eczema was estimated by asking young children to complete the questionnaire with the help of their parents. They were asked to leave blank any questions you feel unable to answer.
次要结局
- Thickness of the skin " Ultrasonography"(8 weeks of treatment)
研究者
Olfat Ibrahim Ali
Assistant Professor , department of physical therapy for basic science, Faculty of Physical Therapy , Cairo university.
Cairo University