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

NCT ID: NCT04444726

Last Updated: 2021-06-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-01-20

Study Completion Date

2020-11-21

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.

Conditions

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Atopic Dermatitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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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.

Group Type EXPERIMENTAL

Ultra Violet A Device.+ Topical medical treatment

Intervention Type DEVICE

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

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

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Iontophoresis device + Topical medical treatment

Intervention Type DEVICE

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 " )

Intervention Type DRUG

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

traditional medical treatment

Traditional medical treatment. which is the betamethasone dipropionate 0.05% " diprolene for 2 times a day for 8 weeks.

Group Type ACTIVE_COMPARATOR

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

Intervention Type DRUG

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

Interventions

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Ultra Violet A Device.+ Topical medical treatment

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

Intervention Type DEVICE

Iontophoresis device + Topical 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 30 mA.

Intervention Type DEVICE

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

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

Intervention Type DRUG

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.
Minimum Eligible Age

9 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Cairo University

OTHER

Sponsor Role lead

Responsible Party

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Olfat Ibrahim Ali

Assistant Professor , department of physical therapy for basic science, Faculty of Physical Therapy , Cairo university.

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Banha University

Banhā, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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2776

Identifier Type: -

Identifier Source: org_study_id

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