<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/NCT03831269</url>
  </required_header>
  <id_info>
    <org_study_id>Kasr Alainy Cairo U</org_study_id>
    <nct_id>NCT03831269</nct_id>
  </id_info>
  <brief_title>Pityriasis Lichenoides Chronica, Role of Streptococcal Infection and Azithromycin</brief_title>
  <official_title>Role of Streptococcal Infection in the Etiopathogenesis of Pityriasis Lichenoides Chronica and the Therapeutic Efficacy of Azithromycin; a Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo 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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Primary outcome:&#xD;
&#xD;
      The primary outcome at end of study (EOS) is to compare the therapeutic efficacy of&#xD;
      Azithromycin in the treatment of pityriasis lichenoides chronica (PLC) with that of a&#xD;
      well-documented line of therapy namely narrow band ultra violet B (nbUVB).&#xD;
&#xD;
      Secondary outcomes:&#xD;
&#xD;
      1. To identify the possibility of streptococcal throat infection as a possible underlying&#xD;
      etiology in PLC.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 2019</start_date>
  <completion_date type="Anticipated">August 2020</completion_date>
  <primary_completion_date type="Anticipated">June 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>Single (Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Efficacy of Azithromycin in treating pityriasis lichenoides chronica</measure>
    <time_frame>12 months</time_frame>
    <description>The clinical improvement of patients with PLC will be evaluated after taking 3 to 6 cycles of azithromycin and will be compared to the clinical outcome of patients that had three sessions of nbUVB for six to eight weeks. Side effects will be documented in each group</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Pityriasis Lichenoides</condition>
  <arm_group>
    <arm_group_label>Azithromycin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The dose of azithromycin will be 10mg/kg/day oral suspension for 3 consecutive days for pediatric patients (&lt;12 years old) and 500mg/day in three consecutive days for adults. The cycle will be repeated every seven days (3 cycles/month) and will be repeated if required according to patient's response up to 6 cycles. Side effects of therapy will be recorded. This protocol is based on previous case reports.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Nb UVB</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Patients recruited for nbUVB phototherapy will have an initial dose of 0.3J-0.5J according to Fitzpatrick's skin type. The dosage will be increased by 0.3J in every other treatment session. The sessions will be given 3 times weekly until improvement is noted or reaching 8 weeks at the EOS. We arrived at this initial dose based on our previous experience with Egyptian patients in Kasr Alainy phototherapy unit in Dermatology Department, Cairo University.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Azithromycin</intervention_name>
    <description>Patients will be randomly distributed and start taking azithromycin according to the known dose /kg/day for repeated cycles till improvement or reaching the end of study</description>
    <arm_group_label>Azithromycin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>nbUVB</intervention_name>
    <description>The patients will be randomly distributed to start nbUVB sessions and clinical improvement will be compared to that of Azithromycin</description>
    <arm_group_label>Nb UVB</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with classic papular eruption of PLC (scaly erythematous papules with&#xD;
             mica-like scales) with diagnosis documented histopathologically with or without&#xD;
             associated hypopigmented lesions&#xD;
&#xD;
          2. Age: &gt; 6 years&#xD;
&#xD;
          3. Both sexes.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients presenting with only hypopigmented macules whom their skin biopsy revealed&#xD;
             PLC.&#xD;
&#xD;
          2. Patients with hypopigmented lesions that reveal mycosis fungoides pathologically.&#xD;
&#xD;
          3. Patients with PLC associated with classic MF.&#xD;
&#xD;
          4. Patients with known absolute contraindications to NB-UVB.&#xD;
&#xD;
          5. Patients with impaired liver and/or kidney functions.&#xD;
&#xD;
          6. Patients with history of any heart disease.&#xD;
&#xD;
          7. Patients with known hypersensitivity to Azithromycin&#xD;
&#xD;
             -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>6 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Amira Elbendary, MBBCh, MSc</last_name>
    <phone>+201555668584</phone>
    <email>aelbendary@kasralainy.edu.eg</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Elbendary, MBBCh, MSc</last_name>
    <email>amira.elbendary@yahoo.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Kasr Alainy Faculty of Medicine Cairo University</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
    <contact>
      <last_name>Mona Abdel Haleim, MD</last_name>
      <email>abdelhalimmona@gmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>February 3, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 5, 2019</study_first_posted>
  <last_update_submitted>February 3, 2019</last_update_submitted>
  <last_update_submitted_qc>February 3, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 5, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Amira Elbendary</investigator_full_name>
    <investigator_title>Teaching assistant</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Streptococcal Infections</mesh_term>
    <mesh_term>Pityriasis</mesh_term>
    <mesh_term>Pityriasis Lichenoides</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Azithromycin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Email contact</ipd_description>
  </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/NCT03831269
org study id: Kasr Alainy Cairo U
nct id: NCT03831269
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Primary outcome:

      The primary outcome at end of study (EOS) is to compare the therapeutic efficacy of
      Azithromycin in the treatment of pityriasis lichenoides chronica (PLC) with that of a
      well-documented line of therapy namely narrow band ultra violet B (nbUVB).

      Secondary outcomes:

      1. To identify the possibility of streptococcal throat infection as a possible underlying
      etiology in PLC.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Investigator)
measure: Efficacy of Azithromycin in treating pityriasis lichenoides chronica
time frame: 12 months
description: The clinical improvement of patients with PLC will be evaluated after taking 3 to 6 cycles of azithromycin and will be compared to the clinical outcome of patients that had three sessions of nbUVB for six to eight weeks. Side effects will be documented in each group
arm group label: Azithromycin
arm group type: Active Comparator
description: The dose of azithromycin will be 10mg/kg/day oral suspension for 3 consecutive days for pediatric patients (<12 years old) and 500mg/day in three consecutive days for adults. The cycle will be repeated every seven days (3 cycles/month) and will be repeated if required according to patient's response up to 6 cycles. Side effects of therapy will be recorded. This protocol is based on previous case reports.
arm group label: Nb UVB
arm group type: Active Comparator
description: Patients recruited for nbUVB phototherapy will have an initial dose of 0.3J-0.5J according to Fitzpatrick's skin type. The dosage will be increased by 0.3J in every other treatment session. The sessions will be given 3 times weekly until improvement is noted or reaching 8 weeks at the EOS. We arrived at this initial dose based on our previous experience with Egyptian patients in Kasr Alainy phototherapy unit in Dermatology Department, Cairo University.
intervention type: Drug
intervention name: Azithromycin
description: Patients will be randomly distributed and start taking azithromycin according to the known dose /kg/day for repeated cycles till improvement or reaching the end of study
arm group label: Azithromycin
intervention type: Other
intervention name: nbUVB
description: The patients will be randomly distributed to start nbUVB sessions and clinical improvement will be compared to that of Azithromycin
arm group label: Nb UVB
criteria: 
gender: All
minimum age: 6 Years
maximum age: N/A
healthy volunteers: No
last name: Amira Elbendary, MBBCh, MSc
phone: +201555668584
email: aelbendary@kasralainy.edu.eg
last name: Elbendary, MBBCh, MSc
email: amira.elbendary@yahoo.com
facility: 
contact: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Amira Elbendary
investigator title: Teaching assistant
mesh term: Streptococcal Infections
mesh term: Pityriasis
mesh term: Pityriasis Lichenoides
mesh term: Azithromycin
sharing ipd: No
ipd description: Email contact