<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04444726</url>
  </required_header>
  <id_info>
    <org_study_id>2776</org_study_id>
    <nct_id>NCT04444726</nct_id>
  </id_info>
  <brief_title>Phototherpy Versus Tapwater Iontophoresis for Management of Atopic Dermatitis in Children.</brief_title>
  <official_title>Phototherpy Versus Tap Water Iontophoresis for Management of Atopic Dermatitis in Children, Randomized Clinical Trial.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      this study is conducted to compare the effect of phototherapy&quot; psoralen plus UVA &quot; bath puva&#xD;
      to tap water iontophoresis in the treatment of atopic dermatitis in children.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Sixty children were selected from the department of dermatology, Banha University Hospital.&#xD;
      Patients were randomly assigned to (Group- A):- 20 children Patients, aged between 6-16 years&#xD;
      old. be treated with Phototherapy, for 3 sessions per week for 8 weeks Plus the traditional&#xD;
      medical treatment. which is the betamethasone dipropionate 0.05% &quot; diprolene for 2 times a&#xD;
      day for 8 weeks. (Group B): 20 children Patients, in Group-B are treated with tap water&#xD;
      iontophoresis, for 8 weeks, 3 sessions /week: the intensity were increased according to the&#xD;
      patient's tolerance, for 20 minutes. Plus the traditional medical treatment. (Group -C) the&#xD;
      control group will treated by only the traditional medical treatment which is the&#xD;
      betamethasone dipropionate 0.05% &quot; diprolene&quot; cream, two times a day for 8 weeks Skin&#xD;
      thickness by ultrasonography and Patient Oriented Eczema Measure(POEM) are measured before&#xD;
      and after 8 weeks of treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 20, 2019</start_date>
  <completion_date type="Actual">November 21, 2020</completion_date>
  <primary_completion_date type="Actual">November 20, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Patient Oriented Eczema Measure&quot; POEM&quot;</measure>
    <time_frame>8 weeks of treatment</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Thickness of the skin &quot; Ultrasonography&quot;</measure>
    <time_frame>8 weeks of treatment</time_frame>
    <description>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</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Atopic Dermatitis</condition>
  <arm_group>
    <arm_group_label>Phototherapy &quot;PUVA&quot; +traditional medical treatmentn</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>patient sock his hands in a bath containing water with the constitution of psoralen &quot;meladinine &quot; 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% &quot; diprolene for 2 times a day for 8 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Tap Water Iontophoresis + Traditional medical treatment</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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% &quot; diprolene for 2 times a day for 8 weeks.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>traditional medical treatment</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Traditional medical treatment. which is the betamethasone dipropionate 0.05% &quot; diprolene for 2 times a day for 8 weeks.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ultra Violet A Device.+ Topical medical treatment</intervention_name>
    <description>Hands of the patient are irradiated in the UVA device after soaking for 20 minutes into 10 litres of water containing psoralen &quot;meladenine capsule&quot;.</description>
    <arm_group_label>Phototherapy &quot;PUVA&quot; +traditional medical treatmentn</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Iontophoresis device + Topical medical treatment</intervention_name>
    <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 30 mA.</description>
    <arm_group_label>Tap Water Iontophoresis + Traditional medical treatment</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Topical medical treatment (Betamethasone dipropionate 0.05% &quot; diprolene &quot; )</intervention_name>
    <description>thin film of the cream is being applied to the affected areas for 2 times per day.</description>
    <arm_group_label>Phototherapy &quot;PUVA&quot; +traditional medical treatmentn</arm_group_label>
    <arm_group_label>Tap Water Iontophoresis + Traditional medical treatment</arm_group_label>
    <arm_group_label>traditional medical treatment</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age between 9 to 16 years.&#xD;
&#xD;
          -  Suffering from AD of dyshidrotic as well as dry types of more than 6-months duration&#xD;
&#xD;
          -  Traditional types of treatment options, including oral or topical corticosteroids,&#xD;
             proved ineffective.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Intolerance history to UV radiation.&#xD;
&#xD;
          -  Skin malignancy at the area to be treated.&#xD;
&#xD;
          -  Acute infection at the treated area.&#xD;
&#xD;
          -  Children received radiotherapy in the area to be treated during the last 6 months.&#xD;
&#xD;
          -  Children received corticosteroid therapy topically within 14 days before treatment, or&#xD;
             systemic corticosteroids or any immunosuppressive drugs within the last 4 weeks.&#xD;
&#xD;
          -  Circulatory and sensory disorders and children with diabetes mellitus.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>9 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Banha University</name>
      <address>
        <city>Banhā</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>June 2021</verification_date>
  <study_first_submitted>June 20, 2020</study_first_submitted>
  <study_first_submitted_qc>June 20, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 23, 2020</study_first_posted>
  <last_update_submitted>June 8, 2021</last_update_submitted>
  <last_update_submitted_qc>June 8, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">June 10, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Olfat Ibrahim Ali</investigator_full_name>
    <investigator_title>Assistant Professor , department of physical therapy for basic science, Faculty of Physical Therapy , Cairo university.</investigator_title>
  </responsible_party>
  <keyword>Atopic dermatitis, Phototherapy, iontophoresis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dermatitis, Atopic</mesh_term>
    <mesh_term>Dermatitis</mesh_term>
    <mesh_term>Eczema</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Betamethasone</mesh_term>
    <mesh_term>Betamethasone Valerate</mesh_term>
    <mesh_term>Betamethasone-17,21-dipropionate</mesh_term>
    <mesh_term>Betamethasone benzoate</mesh_term>
    <mesh_term>Betamethasone sodium phosphate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Data will be shared after 6 month of publication .</ipd_description>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
    <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04444726
org study id: 2776
nct id: NCT04444726
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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.
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Patient Oriented Eczema Measure" POEM"
time frame: 8 weeks of treatment
description: 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.
measure: Thickness of the skin " Ultrasonography"
time frame: 8 weeks of treatment
description: 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
arm group label: Phototherapy "PUVA" +traditional medical treatmentn
arm group type: Experimental
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.
arm group label: Tap Water Iontophoresis + Traditional medical treatment
arm group type: Experimental
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.
arm group label: traditional medical treatment
arm group type: Active Comparator
description: Traditional medical treatment. which is the betamethasone dipropionate 0.05% " diprolene for 2 times a day for 8 weeks.
intervention type: Device
intervention name: Ultra Violet A Device.+ Topical medical treatment
description: Hands of the patient are irradiated in the UVA device after soaking for 20 minutes into 10 litres of water containing psoralen "meladenine capsule".
arm group label: Phototherapy "PUVA" +traditional medical treatmentn
intervention type: Device
intervention name: Iontophoresis device + Topical medical treatment
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 30 mA.
arm group label: Tap Water Iontophoresis + Traditional medical treatment
intervention type: Drug
intervention name: Topical medical treatment (Betamethasone dipropionate 0.05% " diprolene " )
description: thin film of the cream is being applied to the affected areas for 2 times per day.
arm group label: Phototherapy "PUVA" +traditional medical treatmentn
arm group label: Tap Water Iontophoresis + Traditional medical treatment
arm group label: traditional medical treatment
criteria: 
gender: All
minimum age: 9 Years
maximum age: 16 Years
healthy volunteers: No
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Olfat Ibrahim Ali
investigator title: Assistant Professor , department of physical therapy for basic science, Faculty of Physical Therapy , Cairo university.
mesh term: Dermatitis, Atopic
mesh term: Dermatitis
mesh term: Eczema
mesh term: Betamethasone
mesh term: Betamethasone Valerate
mesh term: Betamethasone-17,21-dipropionate
mesh term: Betamethasone benzoate
mesh term: Betamethasone sodium phosphate
sharing ipd: Yes
ipd description: Data will be shared after 6 month of publication .
ipd info type: Informed Consent Form (ICF)
ipd info type: Clinical Study Report (CSR)