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/NCT05973097</url>
    </required_header>
    <id_info>
      <org_study_id>PUTHM912068</org_study_id>
      <nct_id>NCT05973097</nct_id>
    </id_info>
    <brief_title>Treatment of Oral Lichen Planus With Paeoniflorin and Photodynamic Therapy</brief_title>
    <official_title>Clinical Study of Combined Treatment of Oral Lichen Planus With Paeoniflorin and Photodynamic Therapy</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 the oral mucosa and is&#xD;
        considered a precancerous condition. It is characterized by white reticular changes in the&#xD;
        oral mucosa, which can progress to erosions and cause pain in severe cases. The pathogenesis&#xD;
        of OLP is still unclear, but it is believed to be a T-lymphocyte-mediated autoimmune disease.&#xD;
        Currently, only symptomatic treatments are available, and there is no definitive cure.&#xD;
  &#xD;
        In this project, we plan to use TCM differentiation to categorize OLP patients and conduct a&#xD;
        randomized controlled clinical trial to demonstrate the enhanced therapeutic effect of&#xD;
        paeoniflorin combined with photodynamic therapy for OLP. The implementation of this project&#xD;
        will provide new insights into the clinical management of OLP, improve our understanding of&#xD;
        the treatment mechanisms, and have important theoretical and clinical implications.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Paeoniflorin, a compound extracted from the traditional Chinese medicine, has&#xD;
        anti-inflammatory and immunomodulatory effects. Photodynamic therapy is a novel local&#xD;
        treatment approach, where photosensitizers selectively target and destroy diseased cells.&#xD;
        Both treatments have shown efficacy in treating OLP when used individually.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">July 30, 2023</start_date>
    <completion_date type="Anticipated">December 30, 2028</completion_date>
    <primary_completion_date type="Anticipated">December 30, 2028</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 (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Efficacy at 1 month of treatment</measure>
      <time_frame>1 month</time_frame>
      <description>According to the trial standard for evaluating the efficacy of atrophic and erosive oral lichen planus (OLP), the evaluation includes both objective and subjective measures.&#xD;
  Objective measure: The size of the lesion is measured by an observer. The physician records and takes photographs of the lesion, noting the location, color, and changes in the area. The color and area changes of the lesion are compared and determined based on the photographic records.&#xD;
  Subjective measure: Visual analogue scales (VAS) are used, which consist of 10 levels. The pain level is recorded, and the assessment is done by the patient.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The curative effect at the later follow-up visit</measure>
      <time_frame>through study completion, an average of 1 year</time_frame>
      <description>According to the trial standard for evaluating the efficacy of atrophic and erosive oral lichen planus (OLP), the evaluation includes both objective and subjective measures.&#xD;
  Objective measure: The size of the lesion is measured by an observer. The physician records and takes photographs of the lesion, noting the location, color, and changes in the area. The color and area changes of the lesion are compared and determined based on the photographic records.&#xD;
  Subjective measure: Visual analogue scales (VAS) are used, which consist of 10 levels. The pain level is recorded, and the assessment is done by the patient.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">156</enrollment>
    <condition>Oral Lichen Planus</condition>
    <arm_group>
      <arm_group_label>total glucosides of paeony treatment</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Total glucosides of paeony capsules were given 0.6 g once, 3 times a day.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>photodynamic therapy treatment</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Cover the lesion with photosensitizer and fix it. Remove the photosensitizer and treat with laser diode.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>glucosides of paeony and photodynamic therapy combined treatment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Glucosides of paeony and photodynamic therapy are combined for the treatment</description>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>total glucosides of paeony treatment</intervention_name>
      <description>Total glucosides of paeony capsules were given 0.6 g once, 3 times a day.</description>
      <arm_group_label>total glucosides of paeony treatment</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>photodynamic therapy treatment</intervention_name>
      <description>Cover the lesion with photosensitizer and fix it. Remove the photosensitizer and treat with laser diode.</description>
      <arm_group_label>photodynamic therapy treatment</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>glucosides of paeony and photodynamic therapy combined treatment</intervention_name>
      <description>Glucosides of paeony and photodynamic therapy are combined for the treatment</description>
      <arm_group_label>glucosides of paeony and photodynamic therapy combined treatment</arm_group_label>
    </intervention>
    <eligibility>
      <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, Dr.</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>
    </location>
    <location_countries>
      <country>China</country>
    </location_countries>
    <reference>
      <citation>van der Meij EH, van der Waal I. Lack of clinicopathologic correlation in the diagnosis of oral lichen planus based on the presently available diagnostic criteria and suggestions for modifications. J Oral Pathol Med. 2003 Oct;32(9):507-12. doi: 10.1034/j.1600-0714.2003.00125.x.</citation>
      <PMID>12969224</PMID>
    </reference>
    <reference>
      <citation>Li J, Chen CX, Shen YH. Effects of total glucosides from paeony (Paeonia lactiflora Pall) roots on experimental atherosclerosis in rats. J Ethnopharmacol. 2011 May 17;135(2):469-75. doi: 10.1016/j.jep.2011.03.045. Epub 2011 Mar 29.</citation>
      <PMID>21453765</PMID>
    </reference>
    <reference>
      <citation>Villa A, Sankar V, Bassani G, Johnson LB, Sroussi H. Dexamethasone solution and dexamethasone in Mucolox for the treatment of oral lichen planus: a preliminary study. Oral Surg Oral Med Oral Pathol Oral Radiol. 2020 Jun;129(6):585-590. doi: 10.1016/j.oooo.2020.02.014. Epub 2020 Mar 25.</citation>
      <PMID>32220595</PMID>
    </reference>
    <reference>
      <citation>Lavaee F, Shadmanpour M. Comparison of the effect of photodynamic therapy and topical corticosteroid on oral lichen planus lesions. Oral Dis. 2019 Nov;25(8):1954-1963. doi: 10.1111/odi.13188. Epub 2019 Oct 2.</citation>
      <PMID>31478283</PMID>
    </reference>
    <reference>
      <citation>Zhou L, Cao T, Wang Y, Yao H, Du G, Tian Z, Tang G. Clinical observation on the treatment of oral lichen planus with total glucosides of paeony capsule combined with corticosteroids. Int Immunopharmacol. 2016 Jul;36:106-110. doi: 10.1016/j.intimp.2016.03.035. Epub 2016 Apr 26.</citation>
      <PMID>27129091</PMID>
    </reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 15, 2023</study_first_submitted>
    <study_first_submitted_qc>July 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 25, 2023</last_update_submitted>
    <last_update_submitted_qc>July 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>oral lichen planus</keyword>
    <keyword>integrated Chinese and Western medicine</keyword>
    <keyword>total glucosides of paeony</keyword>
    <keyword>photodynamic therapy</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/NCT05973097
  org study id: PUTHM912068
  nct id: NCT05973097
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Oral lichen planus (OLP) is a common chronic inflammatory disease of the oral mucosa and is
        considered a precancerous condition. It is characterized by white reticular changes in the
        oral mucosa, which can progress to erosions and cause pain in severe cases. The pathogenesis
        of OLP is still unclear, but it is believed to be a T-lymphocyte-mediated autoimmune disease.
        Currently, only symptomatic treatments are available, and there is no definitive cure.
  
        In this project, we plan to use TCM differentiation to categorize OLP patients and conduct a
        randomized controlled clinical trial to demonstrate the enhanced therapeutic effect of
        paeoniflorin combined with photodynamic therapy for OLP. The implementation of this project
        will provide new insights into the clinical management of OLP, improve our understanding of
        the treatment mechanisms, and have important theoretical and clinical implications.
  Paeoniflorin, a compound extracted from the traditional Chinese medicine, has
        anti-inflammatory and immunomodulatory effects. Photodynamic therapy is a novel local
        treatment approach, where photosensitizers selectively target and destroy diseased cells.
        Both treatments have shown efficacy in treating OLP when used individually.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Efficacy at 1 month of treatment
  time frame: 1 month
  description: According to the trial standard for evaluating the efficacy of atrophic and erosive oral lichen planus (OLP), the evaluation includes both objective and subjective measures.
  Objective measure: The size of the lesion is measured by an observer. The physician records and takes photographs of the lesion, noting the location, color, and changes in the area. The color and area changes of the lesion are compared and determined based on the photographic records.
  Subjective measure: Visual analogue scales (VAS) are used, which consist of 10 levels. The pain level is recorded, and the assessment is done by the patient.
  measure: The curative effect at the later follow-up visit
  time frame: through study completion, an average of 1 year
  description: According to the trial standard for evaluating the efficacy of atrophic and erosive oral lichen planus (OLP), the evaluation includes both objective and subjective measures.
  Objective measure: The size of the lesion is measured by an observer. The physician records and takes photographs of the lesion, noting the location, color, and changes in the area. The color and area changes of the lesion are compared and determined based on the photographic records.
  Subjective measure: Visual analogue scales (VAS) are used, which consist of 10 levels. The pain level is recorded, and the assessment is done by the patient.
  arm group label: total glucosides of paeony treatment
  arm group type: Active Comparator
  description: Total glucosides of paeony capsules were given 0.6 g once, 3 times a day.
  arm group label: photodynamic therapy treatment
  arm group type: Active Comparator
  description: Cover the lesion with photosensitizer and fix it. Remove the photosensitizer and treat with laser diode.
  arm group label: glucosides of paeony and photodynamic therapy combined treatment
  arm group type: Experimental
  description: Glucosides of paeony and photodynamic therapy are combined for the treatment
  intervention type: Drug
  intervention name: total glucosides of paeony treatment
  description: Total glucosides of paeony capsules were given 0.6 g once, 3 times a day.
  arm group label: total glucosides of paeony treatment
  intervention type: Other
  intervention name: photodynamic therapy treatment
  description: Cover the lesion with photosensitizer and fix it. Remove the photosensitizer and treat with laser diode.
  arm group label: photodynamic therapy treatment
  intervention type: Other
  intervention name: glucosides of paeony and photodynamic therapy combined treatment
  description: Glucosides of paeony and photodynamic therapy are combined for the treatment
  arm group label: glucosides of paeony and photodynamic therapy combined treatment
  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, Dr.
  phone: 010-82266125
  email: wisdomzhangzhihui@163.com
  last name: Lin Zeng
  facility: 
  status: Recruiting
  contact: 
  country: China
  citation: van der Meij EH, van der Waal I. Lack of clinicopathologic correlation in the diagnosis of oral lichen planus based on the presently available diagnostic criteria and suggestions for modifications. J Oral Pathol Med. 2003 Oct;32(9):507-12. doi: 10.1034/j.1600-0714.2003.00125.x.
  PMID: 12969224
  citation: Li J, Chen CX, Shen YH. Effects of total glucosides from paeony (Paeonia lactiflora Pall) roots on experimental atherosclerosis in rats. J Ethnopharmacol. 2011 May 17;135(2):469-75. doi: 10.1016/j.jep.2011.03.045. Epub 2011 Mar 29.
  PMID: 21453765
  citation: Villa A, Sankar V, Bassani G, Johnson LB, Sroussi H. Dexamethasone solution and dexamethasone in Mucolox for the treatment of oral lichen planus: a preliminary study. Oral Surg Oral Med Oral Pathol Oral Radiol. 2020 Jun;129(6):585-590. doi: 10.1016/j.oooo.2020.02.014. Epub 2020 Mar 25.
  PMID: 32220595
  citation: Lavaee F, Shadmanpour M. Comparison of the effect of photodynamic therapy and topical corticosteroid on oral lichen planus lesions. Oral Dis. 2019 Nov;25(8):1954-1963. doi: 10.1111/odi.13188. Epub 2019 Oct 2.
  PMID: 31478283
  citation: Zhou L, Cao T, Wang Y, Yao H, Du G, Tian Z, Tang G. Clinical observation on the treatment of oral lichen planus with total glucosides of paeony capsule combined with corticosteroids. Int Immunopharmacol. 2016 Jul;36:106-110. doi: 10.1016/j.intimp.2016.03.035. Epub 2016 Apr 26.
  PMID: 27129091
  responsible party type: Sponsor
  mesh term: Lichen Planus, Oral
  mesh term: Lichen Planus
  sharing ipd: No