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

Cairo University60 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Atopic Dermatitis

Interventions

Ultra Violet A Device.+ Topical medical treatmentDEVICE

Hands of the patient are irradiated in the UVA device after soaking for 20 minutes into 10 litres of water containing psoralen "meladenine capsule".

Iontophoresis device + Topical medical treatmentDEVICE

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.

Topical medical treatment (Betamethasone dipropionate 0.05% " diprolene " )DRUG

thin film of the cream is being applied to the affected areas for 2 times per day.

Eligibility

Sex: ALLMin age: 9 YearsMax age: 16 Years

Medical Language ↔ Plain English

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.

Locations (1)

Banha University

Banhā, Egypt

Outcomes

Primary Outcomes

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.

Time frame: 8 weeks of treatment

Secondary Outcomes

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

Time frame: 8 weeks of treatment

Data from ClinicalTrials.gov

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