<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/NCT04476186</url>
  </required_header>
  <id_info>
    <org_study_id>site of study assiut U H</org_study_id>
    <nct_id>NCT04476186</nct_id>
  </id_info>
  <brief_title>The Effectiveness of Oral Acyclovir in the Treatment of Molluscum Contagiosum in Children</brief_title>
  <official_title>The Effectiveness of Oral Acyclovir in the Treatment of Molluscum Contagiosum in Children</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Dalia Mahran</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>assistant professor Ghada M. Khafagy</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Dr. Marwa Diaaeldeen Abbass Hasan</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Prof. Dr. Emad Taha Abd-Elahim Ebiad</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Assiut University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The investigators will study the effectiveness of acyclovir in the treatment of molluscum&#xD;
      contagiosum in assiut university hospital - dermatological out patient clinic the treatment&#xD;
      group will receive acyclovir 200 mg 5 times per day the controlled group will receive local&#xD;
      KOH solution&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study population:&#xD;
&#xD;
      Site of the study: The outpatient dermatological clinic in Assiut university hospital.&#xD;
&#xD;
      Participants: children (2 -16) years' old attending dermatological clinic in Assiut&#xD;
      university hospital and their parents.&#xD;
&#xD;
      Methodology in details:&#xD;
&#xD;
        1. We will use the social media as &quot; Facebook&quot; to invite patient to visit the clinic and&#xD;
           follow up them due to the protective measures of covid 19.&#xD;
&#xD;
        2. Diagnosis of the patient with molluscum contagiosum according to the clinical picture&#xD;
&#xD;
        3. Collecting data including personal and clinical data through interviewing the patient&#xD;
           and his or her parents&#xD;
&#xD;
        4. Pictures of the lesions will be taken before and after treatment after patient consent.&#xD;
&#xD;
        5. We will Randomly assigning the patient to either treatment group or controlled group&#xD;
           according to simple random table&#xD;
&#xD;
        6. Prescribing the treatment according to the patient group&#xD;
&#xD;
        7. Follow up of the patient after 1 weak and each week according to the response to&#xD;
           treatment or presence of complication&#xD;
&#xD;
      Inclusion criteria:&#xD;
&#xD;
      Children (5 -15) years old with Molluscum contagiosum.&#xD;
&#xD;
      Exclusion criteria:&#xD;
&#xD;
        1. Molluscum contagiosum with Inflamed spot&#xD;
&#xD;
        2. Known immune compromised children&#xD;
&#xD;
        3. Molluscum lesion in the eye lid.&#xD;
&#xD;
        4. Children with renal impairment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">June 15, 2020</start_date>
  <completion_date type="Anticipated">December 30, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 29, 2021</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>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>The percentage of patient with complete clearance of all molluscum lesions.</measure>
    <time_frame>3 month for each participant</time_frame>
    <description>we will measure the percentage of patient recovered from all lesion</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">35</enrollment>
  <condition>Molluscum Contagiosum</condition>
  <arm_group>
    <arm_group_label>treatment group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>200 mg of oral acyclovir 5 timed per day for 5 days per week for maximum 1 month</description>
  </arm_group>
  <arm_group>
    <arm_group_label>controlled group</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>KOH 10 % solution local application with apiece of cotton 2 time per day maximum for 1 month</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Acyclovir</intervention_name>
    <description>oral syrp</description>
    <arm_group_label>treatment group</arm_group_label>
    <other_name>Zovirax - Acyclovir</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>KOH 10 %</intervention_name>
    <description>solution for local application</description>
    <arm_group_label>controlled group</arm_group_label>
    <other_name>KOH</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children (2 -16) years old with Molluscum contagiosum.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Molluscum contagiosum with Inflamed spot Known immune compromised children Molluscum&#xD;
             lesion in the eye lid. Children with renal impairment.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>2 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ghada Mahmoud, Assist Prof</last_name>
    <role>Principal Investigator</role>
    <affiliation>Cairo University</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Hamdy Gomaa</last_name>
    <phone>00201000882184</phone>
    <email>dhamdy2003@yahoo.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Hamdy Gomaa</name>
      <address>
        <city>Assiut</city>
        <state>New Assiut City</state>
        <zip>71684</zip>
        <country>Egypt</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Hamdy Gomaa</last_name>
      <phone>00201000882184</phone>
      <email>dhamdy2003@yahoo.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 6, 2020</study_first_submitted>
  <study_first_submitted_qc>July 14, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 20, 2020</study_first_posted>
  <last_update_submitted>July 14, 2020</last_update_submitted>
  <last_update_submitted_qc>July 14, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 20, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Assiut University</investigator_affiliation>
    <investigator_full_name>Dalia Mahran</investigator_full_name>
    <investigator_title>professor of public health and community medicine</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Molluscum Contagiosum</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Acyclovir</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT04476186
org study id: site of study assiut U H
nct id: NCT04476186
lead sponsor: 
collaborator: 
collaborator: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
The investigators will study the effectiveness of acyclovir in the treatment of molluscum
      contagiosum in assiut university hospital - dermatological out patient clinic the treatment
      group will receive acyclovir 200 mg 5 times per day the controlled group will receive local
      KOH solution
Study population:

      Site of the study: The outpatient dermatological clinic in Assiut university hospital.

      Participants: children (2 -16) years' old attending dermatological clinic in Assiut
      university hospital and their parents.

      Methodology in details:

        1. We will use the social media as " Facebook" to invite patient to visit the clinic and
           follow up them due to the protective measures of covid 19.

        2. Diagnosis of the patient with molluscum contagiosum according to the clinical picture

        3. Collecting data including personal and clinical data through interviewing the patient
           and his or her parents

        4. Pictures of the lesions will be taken before and after treatment after patient consent.

        5. We will Randomly assigning the patient to either treatment group or controlled group
           according to simple random table

        6. Prescribing the treatment according to the patient group

        7. Follow up of the patient after 1 weak and each week according to the response to
           treatment or presence of complication

      Inclusion criteria:

      Children (5 -15) years old with Molluscum contagiosum.

      Exclusion criteria:

        1. Molluscum contagiosum with Inflamed spot

        2. Known immune compromised children

        3. Molluscum lesion in the eye lid.

        4. Children with renal impairment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: The percentage of patient with complete clearance of all molluscum lesions.
time frame: 3 month for each participant
description: we will measure the percentage of patient recovered from all lesion
arm group label: treatment group
arm group type: Active Comparator
description: 200 mg of oral acyclovir 5 timed per day for 5 days per week for maximum 1 month
arm group label: controlled group
arm group type: Placebo Comparator
description: KOH 10 % solution local application with apiece of cotton 2 time per day maximum for 1 month
intervention type: Drug
intervention name: Acyclovir
description: oral syrp
arm group label: treatment group
other name: Zovirax - Acyclovir
intervention type: Drug
intervention name: KOH 10 %
description: solution for local application
arm group label: controlled group
other name: KOH
criteria: 
gender: All
minimum age: 2 Years
maximum age: 16 Years
healthy volunteers: No
last name: Ghada Mahmoud, Assist Prof
role: Principal Investigator
affiliation: Cairo University
last name: Hamdy Gomaa
phone: 00201000882184
email: dhamdy2003@yahoo.com
facility: 
status: Recruiting
contact: 
country: Egypt
responsible party type: Sponsor-Investigator
investigator affiliation: Assiut University
investigator full name: Dalia Mahran
investigator title: professor of public health and community medicine
mesh term: Molluscum Contagiosum
mesh term: Acyclovir
sharing ipd: No