Phototherpy Versus Tapwater Iontophoresis for Management of Atopic Dermatitis in Children.

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Phototherpy Versus Tap Water Iontophoresis for Management of Atopic Dermatitis in Children, Randomized Clinical Trial.

Conditions
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Atopic Dermatitis

Intervention / Treatment
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* Device: Ultra Violet A Device.+ Topical medical treatment
* Device: Iontophoresis device + Topical medical treatment
* Drug: Topical medical treatment (Betamethasone dipropionate 0.05%  diprolene  )


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 9 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Phototherapy PUVA +traditional medical treatmentn<br>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. | Device: Ultra Violet A Device.+ Topical medical treatment<br>* Hands of the patient are irradiated in the UVA device after soaking for 20 minutes into 10 litres of water containing psoralen meladenine capsule.<br>Drug: Topical medical treatment (Betamethasone dipropionate 0.05%  diprolene  )<br>* thin film of the cream is being applied to the affected areas for 2 times per day.<br>|
| Experimental: Tap Water Iontophoresis + Traditional medical treatment<br>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. | Device: Iontophoresis device + Topical medical treatment<br>* 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 30 mA.<br>Drug: Topical medical treatment (Betamethasone dipropionate 0.05%  diprolene  )<br>* thin film of the cream is being applied to the affected areas for 2 times per day.<br>|
| Active Comparator: traditional medical treatment<br>Traditional medical treatment. which is the betamethasone dipropionate 0.05%  diprolene for 2 times a day for 8 weeks. | Drug: Topical medical treatment (Betamethasone dipropionate 0.05%  diprolene  )<br>* thin film of the cream is being applied to the affected areas for 2 times per day.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient Oriented Eczema Measure POEM | 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. | 8 weeks of treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Thickness of the skin  Ultrasonography | Assessment of the skin thickness was done using the ultrasonography 7.5 MHz. The ultrasound imaging system was used to measure the thickness of the skin at the affected site | 8 weeks of treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Atopic dermatitis, Phototherapy, iontophoresis