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 Title of Study: “Phototherpy Versus Tap Water Iontophoresis for Management of Atopic Dermatitis in Children, Randomized Clinical Trial.”
- Study Type: Interventional
- Study Design
- Allocation: Randomized
- Intervention Model: Parallel Assignment
- Primary Purpose: Treatment
- Masking: Double (Participant, Outcomes Assessor)
- Study Primary Completion Date: November 20, 2020
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.
- 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”.
- Device: 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.
Arms, Groups and Cohorts
- Experimental: Phototherapy “PUVA” +traditional medical treatmentn
- 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.
- Experimental: Tap Water Iontophoresis + Traditional 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 30mA. Plus the traditional medical treatment. which is the betamethasone dipropionate 0.05% ” diprolene for 2 times a day for 8 weeks.
- Active Comparator: traditional medical treatment
- Traditional medical treatment. which is the betamethasone dipropionate 0.05% ” diprolene for 2 times a day for 8 weeks.
Clinical Trial Outcome Measures
- 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.
- 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
Participating in This Clinical Trial
- 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.
Gender Eligibility: All
Minimum Age: 9 Years
Maximum Age: 16 Years
Are Healthy Volunteers Accepted: No
- Lead Sponsor
- Cairo University
- Provider of Information About this Clinical Study
- Principal Investigator: Olfat Ibrahim Ali, Assistant Professor , department of physical therapy for basic science, Faculty of Physical Therapy , Cairo university. – Cairo University
- Overall Contact(s)
- Ali O Selim, PhD, 00201221954363, firstname.lastname@example.org
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