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.
1 other identifier
interventional
60
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Jan 2019
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 20, 2019
CompletedFirst Submitted
Initial submission to the registry
June 20, 2020
CompletedFirst Posted
Study publicly available on registry
June 23, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 20, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
November 21, 2020
CompletedJune 10, 2021
June 1, 2021
1.8 years
June 20, 2020
June 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (1)
Thickness of the skin " Ultrasonography"
8 weeks of treatment
Study Arms (3)
Phototherapy "PUVA" +traditional medical treatmentn
EXPERIMENTALpatient 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.
Tap Water Iontophoresis + Traditional medical treatment
EXPERIMENTALTap-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.
traditional medical treatment
ACTIVE COMPARATORTraditional medical treatment. which is the betamethasone dipropionate 0.05% " diprolene for 2 times a day for 8 weeks.
Interventions
Hands of the patient are irradiated in the UVA device after soaking for 20 minutes into 10 litres of water containing psoralen "meladenine capsule".
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.
thin film of the cream is being applied to the affected areas for 2 times per day.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Banha University
Banhā, Egypt
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor , department of physical therapy for basic science, Faculty of Physical Therapy , Cairo university.
Study Record Dates
First Submitted
June 20, 2020
First Posted
June 23, 2020
Study Start
January 20, 2019
Primary Completion
November 20, 2020
Study Completion
November 21, 2020
Last Updated
June 10, 2021
Record last verified: 2021-06
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- ICF, CSR
Data will be shared after 6 month of publication .