xml: <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/NCT06004583</url>
    </required_header>
    <id_info>
      <org_study_id>30.12.2021/567</org_study_id>
      <nct_id>NCT06004583</nct_id>
    </id_info>
    <brief_title>C-Reactive Protein/Albumin Ratio and Acne Vulgaris</brief_title>
    <official_title>Relationships Between Disease Severity and The C-Reactive Protein/Albumin Ratio and Various Hematological Parameters in Patients With Acne Vulgaris</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ataturk University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ataturk 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>
        Objective: Acne vulgaris, an inflammatory disease, was investigated in this study with the&#xD;
        claim that C-reactive protein (CRP) / albumin ratio and some hematological parameter ratios&#xD;
        have the potential to be used as inflammatory markers to monitor disease severity and&#xD;
        prognosis.&#xD;
  &#xD;
        Methods: A descriptive cross-sectional study was conducted with two groups of patients aged&#xD;
        18-65 years, 61 patients diagnosed with acne vulgaris and 35 healthy control patients, and&#xD;
        routine hemogram and biochemical parameters were compared. The Global Acne Severity Index was&#xD;
        used to determine the severity of acne vulgaris.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 5, 2022</start_date>
    <completion_date type="Actual">May 1, 2023</completion_date>
    <primary_completion_date type="Actual">February 2, 2023</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Control</observational_model>
      <time_perspective>Retrospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>CRP/albumin ratio</measure>
      <time_frame>3 months</time_frame>
      <description>Statistical difference between groups</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Usage of CRP/albumin ratio as a Biomarker</measure>
      <time_frame>3 months</time_frame>
      <description>New detection of CRP/albumin ratio as a new biomarker in the Acne patients</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">96</enrollment>
    <condition>Acne Vulgaris</condition>
    <arm_group>
      <arm_group_label>Acne group</arm_group_label>
      <description>Acne Vulgaris Diagnosed Patients</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control group</arm_group_label>
      <description>Healthy participants</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Biochemical blood analysis</intervention_name>
      <description>Serum CRP and albumin levels</description>
      <arm_group_label>Acne group</arm_group_label>
      <arm_group_label>Control group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Acne vulgaris patients and control healthy individuals&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Acne vulgaris patients diagnosed by a dermatologist&#xD;
  &#xD;
            -  Healthy participants without acne&#xD;
  &#xD;
            -  18-40 years of age&#xD;
  &#xD;
            -  Voluntary participation&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Aged below18 or above 40 years&#xD;
  &#xD;
            -  Not voluntarily participated patents&#xD;
  &#xD;
            -  Pregnants, breast milked mothers, emergency situations&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>40 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>AtaturkU</name>
        <address>
          <city>Erzurum</city>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 16, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ataturk University</investigator_affiliation>
      <investigator_full_name>Erdal Pala</investigator_full_name>
      <investigator_title>Ass.Prof</investigator_title>
    </responsible_party>
    <keyword>acne vulgaris</keyword>
    <keyword>CRP albumin ratio</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Acne Vulgaris</mesh_term>
    </condition_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06004583
  org study id: 30.12.2021/567
  nct id: NCT06004583
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Objective: Acne vulgaris, an inflammatory disease, was investigated in this study with the
        claim that C-reactive protein (CRP) / albumin ratio and some hematological parameter ratios
        have the potential to be used as inflammatory markers to monitor disease severity and
        prognosis.
  
        Methods: A descriptive cross-sectional study was conducted with two groups of patients aged
        18-65 years, 61 patients diagnosed with acne vulgaris and 35 healthy control patients, and
        routine hemogram and biochemical parameters were compared. The Global Acne Severity Index was
        used to determine the severity of acne vulgaris.
  observational model: Case-Control
  time perspective: Retrospective
  measure: CRP/albumin ratio
  time frame: 3 months
  description: Statistical difference between groups
  measure: Usage of CRP/albumin ratio as a Biomarker
  time frame: 3 months
  description: New detection of CRP/albumin ratio as a new biomarker in the Acne patients
  arm group label: Acne group
  description: Acne Vulgaris Diagnosed Patients
  arm group label: Control group
  description: Healthy participants
  intervention type: Diagnostic Test
  intervention name: Biochemical blood analysis
  description: Serum CRP and albumin levels
  arm group label: Acne group
  arm group label: Control group
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 40 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Turkey
  responsible party type: Principal Investigator
  investigator affiliation: Ataturk University
  investigator full name: Erdal Pala
  investigator title: Ass.Prof
  mesh term: Acne Vulgaris