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

June 8, 2021 updated by: Olfat Ibrahim Ali, Cairo University

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Enrollment (Actual)

60

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Banhā, Egypt
        • Banha University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

9 years to 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Device: 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".
Drug: 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.
Experimental: 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.
Drug: 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.
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.
Active Comparator: traditional medical treatment
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 " )
thin film of the cream is being applied to the affected areas for 2 times per day.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Patient Oriented Eczema Measure" POEM"
Time Frame: 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.
8 weeks of treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Thickness of the skin " Ultrasonography"
Time Frame: 8 weeks of treatment
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 20, 2019

Primary Completion (Actual)

November 20, 2020

Study Completion (Actual)

November 21, 2020

Study Registration Dates

First Submitted

June 20, 2020

First Submitted That Met QC Criteria

June 20, 2020

First Posted (Actual)

June 23, 2020

Study Record Updates

Last Update Posted (Actual)

June 10, 2021

Last Update Submitted That Met QC Criteria

June 8, 2021

Last Verified

June 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2776

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Data will be shared after 6 month of publication .

IPD Sharing Supporting Information Type

  • Informed Consent Form (ICF)
  • Clinical Study Report (CSR)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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