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

Primary Purpose

Atopic Dermatitis

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Ultra Violet A Device.+ Topical medical treatment
Iontophoresis device + Topical medical treatment
Topical medical treatment (Betamethasone dipropionate 0.05% " diprolene " )
Sponsored by
Cairo University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Atopic Dermatitis focused on measuring Atopic dermatitis, Phototherapy, iontophoresis

Eligibility Criteria

9 Years - 16 Years (Child)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Banha University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

Phototherapy "PUVA" +traditional medical treatmentn

Tap Water Iontophoresis + Traditional medical treatment

traditional medical treatment

Arm Description

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.

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.

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
June 20, 2020
Last Updated
June 8, 2021
Sponsor
Cairo University
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1. Study Identification

Unique Protocol Identification Number
NCT04444726
Brief Title
Phototherpy Versus Tapwater Iontophoresis for Management of Atopic Dermatitis in Children.
Official Title
Phototherpy Versus Tap Water Iontophoresis for Management of Atopic Dermatitis in Children, Randomized Clinical Trial.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2021
Overall Recruitment Status
Completed
Study Start Date
January 20, 2019 (Actual)
Primary Completion Date
November 20, 2020 (Actual)
Study Completion Date
November 21, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atopic Dermatitis
Keywords
Atopic dermatitis, Phototherapy, iontophoresis

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
60 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Phototherapy "PUVA" +traditional medical treatmentn
Arm Type
Experimental
Arm Description
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.
Arm Title
Tap Water Iontophoresis + Traditional medical treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
traditional medical treatment
Arm Type
Active Comparator
Arm Description
Traditional medical treatment. which is the betamethasone dipropionate 0.05% " diprolene for 2 times a day for 8 weeks.
Intervention Type
Device
Intervention Name(s)
Ultra Violet A Device.+ Topical medical treatment
Intervention Description
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
Intervention Name(s)
Iontophoresis device + Topical medical treatment
Intervention Description
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
Drug
Intervention Name(s)
Topical medical treatment (Betamethasone dipropionate 0.05% " diprolene " )
Intervention Description
thin film of the cream is being applied to the affected areas for 2 times per day.
Primary Outcome Measure Information:
Title
Patient Oriented Eczema Measure" POEM"
Description
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 Outcome Measure Information:
Title
Thickness of the skin " Ultrasonography"
Description
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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
9 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Banha University
City
Banhā
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be shared after 6 month of publication .

Learn more about this trial

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

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