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

Cairo University (CU)

Status: Completed

Conditions: Atopic Dermatitis

Treatments: Drug: Topical medical treatment (Betamethasone dipropionate 0.05% " diprolene " ); Device: Ultra Violet A Device.+ Topical medical treatment; Device: Iontophoresis device + Topical medical treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04444726

2776

Details and patient eligibility

About

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.

Full 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.

Enrollment: 60 patients

Sex: All

Ages: 9 to 16 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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60 participants in 3 patient groups

Phototherapy "PUVA" +traditional medical treatmentn

Experimental group

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.

Treatment:

Drug: Topical medical treatment (Betamethasone dipropionate 0.05% " diprolene " )

Device: Ultra Violet A Device.+ Topical medical treatment

Tap Water Iontophoresis + Traditional medical treatment

Experimental group

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.

Treatment:

Drug: Topical medical treatment (Betamethasone dipropionate 0.05% " diprolene " )

Device: Iontophoresis device + Topical medical treatment

traditional medical treatment

Active Comparator group

Description:

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

Treatment:

Drug: Topical medical treatment (Betamethasone dipropionate 0.05% " diprolene " )