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

Atopic Dermatitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04444726
• Other study ID #: 2776
• Status: Completed
• Phase: N/A
• Start date: January 20, 2019
• Est. completion date: November 21, 2020

Study information

• Verified date: June 2021
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: November 21, 2020
• Est. primary completion date: November 20, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years to 16 Years

Eligibility

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.

Related Conditions & MeSH terms

• Atopic Dermatitis
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

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".
• 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.

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.

Locations

Country	Name	City	State
Egypt	Banha University	Banha

Sponsors (1)

Lead Sponsor	Collaborator
Cairo University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	8 weeks of treatment
Secondary	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	8 weeks of treatment