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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04444726
Enrollment
60
Registered
2020-06-23
Start date
2019-01-20
Completion date
2020-11-21
Last updated
2021-06-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic Dermatitis

Keywords

Atopic dermatitis, Phototherapy, iontophoresis

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.

Interventions

DEVICEUltra 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.

DEVICEIontophoresis 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.

DRUGTopical medical treatment (Betamethasone dipropionate 0.05% diprolene )

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
9 Years to 16 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Patient Oriented Eczema Measure POEM8 weeks of treatmentThe 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

MeasureTime frameDescription
Thickness of the skin Ultrasonography8 weeks of treatmentAssessment 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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026