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Completed

NCT Number: NCT04444726

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

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.

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Key information

Conditions

Atopic Dermatitis Congenital, Hereditary, and Neonatal Diseases and Abnormalities Dermatitis Dermatitis, Atopic Genetic Diseases, Inborn Hypersensitivity Hypersensitivity, Immediate Immune System Diseases Skin Diseases Skin Diseases, Eczematous Skin Diseases, Genetic Skin and Connective Tissue Diseases

Age range

9 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Banha University

Banhā, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Ultra Violet A Device.+ Topical medical treatment

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".

Iontophoresis device + Topical medical treatment

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 " )

Drug

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study title

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

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Jun 23, 2020
Registry last updated
Jun 10, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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