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/NCT05997173</url>
    </required_header>
    <id_info>
      <org_study_id>BMU81800920402</org_study_id>
      <nct_id>NCT05997173</nct_id>
    </id_info>
    <brief_title>The Regulatory Role of Immune Response in Oral Lichen Planus</brief_title>
    <official_title>The Regulatory Role of Immune Response in Oral Lichen Planus With Mental Disorders</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Peking University Third Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Peking University Third Hospital</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>
        Oral lichen planus (OLP) is a common chronic inflammatory disease of Oral mucosa. The&#xD;
        pathogenesis of OLP is not clear, and there is no effective method to cure it. In vitro,&#xD;
        previous studies have shown that oral mucosal mesenchymal stem cell cells (MSCs) can secrete&#xD;
        Ido, which is involved in the pathogenesis of OLP. It has been proved that mental disorders&#xD;
        such as depression and anxiety play an important role in the pathogenesis and treatment of&#xD;
        OLP. Mental stress factors can cause abnormal changes of inflammatory factors, leading to&#xD;
        immune dysfunction, which is also one of the main causes of OLP. In this study, we integrated&#xD;
        the advantages of stomatology, psychiatry, neurobiology and traditional Chinese medicine,&#xD;
        focused on the clinical problems of mental disorders with oral mucosal comorbidity, and&#xD;
        assessed the depressive and anxiety status of OLP patients, so as to improve the therapeutic&#xD;
        effect of OLP.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">September 7, 2020</start_date>
    <completion_date type="Anticipated">February 2025</completion_date>
    <primary_completion_date type="Anticipated">February 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Case-Crossover</observational_model>
      <time_perspective>Cross-Sectional</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>The scores of the scale with the symptoms and signs of the disease</measure>
      <time_frame>During the initial diagnosis，through study completion, an average of 1 year</time_frame>
      <description>Psychological factors in OLP patients and normal controls were assessed using psychological scales such as the Hamilton Anxiety Scale (HAMA) and Hamilton Depression Scale (HAMD). Tissue and blood samples were collected during visits, and the concentrations of inflammatory factors in normal and lesion tissues were detected using immunofluorescence, flow cytometry, and enzyme-linked immunosorbent assay (ELISA). Statistical analysis was performed to determine the correlation between emotional disorders and inflammation in OLP patients, aiming to elucidate the underlying pathogenic mechanisms.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Immune inflammatory response</measure>
      <time_frame>During the initial diagnosis，through study completion, an average of 1 year</time_frame>
      <description>Psychological factors in OLP patients and normal controls were assessed using psychological scales such as the Hamilton Anxiety Scale (HAMA) and Hamilton Depression Scale (HAMD). Tissue and blood samples were collected during visits, and the concentrations of inflammatory factors in normal and lesion tissues were detected using immunofluorescence, flow cytometry, and enzyme-linked immunosorbent assay (ELISA). Statistical analysis was performed to determine the correlation between emotional disorders and inflammation in OLP patients, aiming to elucidate the underlying pathogenic mechanisms.</description>
    </secondary_outcome>
    <number_of_groups>3</number_of_groups>
    <enrollment type="Anticipated">90</enrollment>
    <condition>Oral Lichen Planus</condition>
    <arm_group>
      <arm_group_label>Control</arm_group_label>
      <description>Normal control group</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Non erosive OLP</arm_group_label>
      <description>Non erosive oral lichen planus</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Erosive OLP</arm_group_label>
      <description>Erosive oral lichen planus</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Control</intervention_name>
      <description>Investigation of scale of control</description>
      <arm_group_label>Control</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Non erosive OLP</intervention_name>
      <description>Investigation of cale of non erosive OLP patients</description>
      <arm_group_label>Non erosive OLP</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Erosive OLP</intervention_name>
      <description>Investigation of cale of erosive OLP patients</description>
      <arm_group_label>Erosive OLP</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Participants with oral lichen planus or control Male or female patients older than 18 years&#xD;
          of age Participants willing to participate with signed informed consent.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  patients with oral lichen planus&#xD;
  &#xD;
            -  male or female patients older than 18 years of age&#xD;
  &#xD;
            -  patients willing to participate with signed informed consent.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  pregnant or lactating&#xD;
  &#xD;
            -  had serious systemic diseases of the heart, lung, liver, and kidney, or had tumors&#xD;
  &#xD;
            -  were unwilling to participate in the experiment.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Zhihui Zhang</last_name>
      <role>Principal Investigator</role>
      <affiliation>Peking University Third Hospital</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Zhihui Zhang</last_name>
      <phone>010-82266125</phone>
      <email>wisdomzhangzhihui@163.com</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Lin Zeng</last_name>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Peking University Third Hospital</name>
        <address>
          <city>Beijing</city>
          <country>China</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Lin Zeng</last_name>
      </contact>
      <contact_backup>
        <phone>01082266872</phone>
      </contact_backup>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <reference>
      <citation>Hashmi AM, Butt Z, Umair M. Is depression an inflammatory condition? A review of available evidence. J Pak Med Assoc. 2013 Jul;63(7):899-906.</citation>
      <PMID>23901717</PMID>
    </reference>
    <reference>
      <citation>Alrashdan MS, Cirillo N, McCullough M. Oral lichen planus: a literature review and update. Arch Dermatol Res. 2016 Oct;308(8):539-51. doi: 10.1007/s00403-016-1667-2. Epub 2016 Jun 27.</citation>
      <PMID>27349424</PMID>
    </reference>
    <reference>
      <citation>Thapar A, Collishaw S, Pine DS, Thapar AK. Depression in adolescence. Lancet. 2012 Mar 17;379(9820):1056-67. doi: 10.1016/S0140-6736(11)60871-4. Epub 2012 Feb 2.</citation>
      <PMID>22305766</PMID>
    </reference>
    <reference>
      <citation>Nitzan U, Carmeli G, Chalamish Y, Braw Y, Kirsch I, Shefet D, Krieger I, Mendlovic S, Bloch Y, Lichtenberg P. Open-Label placebo for the treatment of unipolar depression: Results from a randomized controlled trial. J Affect Disord. 2020 Nov 1;276:707-710. doi: 10.1016/j.jad.2020.07.077. Epub 2020 Jul 21.</citation>
      <PMID>32871704</PMID>
    </reference>
    <reference>
      <citation>Vilar-Villanueva M, Gandara-Vila P, Blanco-Aguilera E, Otero-Rey EM, Rodriguez-Lado L, Garcia-Garcia A, Blanco-Carrion A. Psychological disorders and quality of life in oral lichen planus patients and a control group. Oral Dis. 2019 Sep;25(6):1645-1651. doi: 10.1111/odi.13106. Epub 2019 May 29.</citation>
      <PMID>30993798</PMID>
    </reference>
    <verification_date>September 2022</verification_date>
    <study_first_submitted>July 15, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 18, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>oral lichen planus</keyword>
    <keyword>depression</keyword>
    <keyword>anxiety</keyword>
    <keyword>mesenchymal stem cells</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Lichen Planus, Oral</mesh_term>
      <mesh_term>Lichen Planus</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT05997173
  org study id: BMU81800920402
  nct id: NCT05997173
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Oral lichen planus (OLP) is a common chronic inflammatory disease of Oral mucosa. The
        pathogenesis of OLP is not clear, and there is no effective method to cure it. In vitro,
        previous studies have shown that oral mucosal mesenchymal stem cell cells (MSCs) can secrete
        Ido, which is involved in the pathogenesis of OLP. It has been proved that mental disorders
        such as depression and anxiety play an important role in the pathogenesis and treatment of
        OLP. Mental stress factors can cause abnormal changes of inflammatory factors, leading to
        immune dysfunction, which is also one of the main causes of OLP. In this study, we integrated
        the advantages of stomatology, psychiatry, neurobiology and traditional Chinese medicine,
        focused on the clinical problems of mental disorders with oral mucosal comorbidity, and
        assessed the depressive and anxiety status of OLP patients, so as to improve the therapeutic
        effect of OLP.
  observational model: Case-Crossover
  time perspective: Cross-Sectional
  measure: The scores of the scale with the symptoms and signs of the disease
  time frame: During the initial diagnosis，through study completion, an average of 1 year
  description: Psychological factors in OLP patients and normal controls were assessed using psychological scales such as the Hamilton Anxiety Scale (HAMA) and Hamilton Depression Scale (HAMD). Tissue and blood samples were collected during visits, and the concentrations of inflammatory factors in normal and lesion tissues were detected using immunofluorescence, flow cytometry, and enzyme-linked immunosorbent assay (ELISA). Statistical analysis was performed to determine the correlation between emotional disorders and inflammation in OLP patients, aiming to elucidate the underlying pathogenic mechanisms.
  measure: Immune inflammatory response
  time frame: During the initial diagnosis，through study completion, an average of 1 year
  description: Psychological factors in OLP patients and normal controls were assessed using psychological scales such as the Hamilton Anxiety Scale (HAMA) and Hamilton Depression Scale (HAMD). Tissue and blood samples were collected during visits, and the concentrations of inflammatory factors in normal and lesion tissues were detected using immunofluorescence, flow cytometry, and enzyme-linked immunosorbent assay (ELISA). Statistical analysis was performed to determine the correlation between emotional disorders and inflammation in OLP patients, aiming to elucidate the underlying pathogenic mechanisms.
  arm group label: Control
  description: Normal control group
  arm group label: Non erosive OLP
  description: Non erosive oral lichen planus
  arm group label: Erosive OLP
  description: Erosive oral lichen planus
  intervention type: Other
  intervention name: Control
  description: Investigation of scale of control
  arm group label: Control
  intervention type: Other
  intervention name: Non erosive OLP
  description: Investigation of cale of non erosive OLP patients
  arm group label: Non erosive OLP
  intervention type: Other
  intervention name: Erosive OLP
  description: Investigation of cale of erosive OLP patients
  arm group label: Erosive OLP
  study pop: 
  sampling method: Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Zhihui Zhang
  role: Principal Investigator
  affiliation: Peking University Third Hospital
  last name: Zhihui Zhang
  phone: 010-82266125
  email: wisdomzhangzhihui@163.com
  last name: Lin Zeng
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: China
  citation: Hashmi AM, Butt Z, Umair M. Is depression an inflammatory condition? A review of available evidence. J Pak Med Assoc. 2013 Jul;63(7):899-906.
  PMID: 23901717
  citation: Alrashdan MS, Cirillo N, McCullough M. Oral lichen planus: a literature review and update. Arch Dermatol Res. 2016 Oct;308(8):539-51. doi: 10.1007/s00403-016-1667-2. Epub 2016 Jun 27.
  PMID: 27349424
  citation: Thapar A, Collishaw S, Pine DS, Thapar AK. Depression in adolescence. Lancet. 2012 Mar 17;379(9820):1056-67. doi: 10.1016/S0140-6736(11)60871-4. Epub 2012 Feb 2.
  PMID: 22305766
  citation: Nitzan U, Carmeli G, Chalamish Y, Braw Y, Kirsch I, Shefet D, Krieger I, Mendlovic S, Bloch Y, Lichtenberg P. Open-Label placebo for the treatment of unipolar depression: Results from a randomized controlled trial. J Affect Disord. 2020 Nov 1;276:707-710. doi: 10.1016/j.jad.2020.07.077. Epub 2020 Jul 21.
  PMID: 32871704
  citation: Vilar-Villanueva M, Gandara-Vila P, Blanco-Aguilera E, Otero-Rey EM, Rodriguez-Lado L, Garcia-Garcia A, Blanco-Carrion A. Psychological disorders and quality of life in oral lichen planus patients and a control group. Oral Dis. 2019 Sep;25(6):1645-1651. doi: 10.1111/odi.13106. Epub 2019 May 29.
  PMID: 30993798
  responsible party type: Sponsor
  mesh term: Lichen Planus, Oral
  mesh term: Lichen Planus
  sharing ipd: No