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/NCT06042010</url>
    </required_header>
    <id_info>
      <org_study_id>Oral medicine_0424-04\2022</org_study_id>
      <nct_id>NCT06042010</nct_id>
    </id_info>
    <brief_title>Oral Zinc Supplement as Adjunctive Therapy for Erosive Oral Lichen Planus</brief_title>
    <official_title>Efficacy of Oral Zinc Supplement as an Adjunctive Therapy for Erosive Oral Lichen Planus (a Randomized, Controlled Clinical Trial)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hams Hamed Abdelrahman</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Alexandria 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>
        Lichen Planus (LP) is a chronic mucocutaneous inflammatory disease and considered as T-cell&#xD;
        mediated autoimmune disorder.&#xD;
  &#xD;
        Zinc is a potent antioxidant micronutrient that contributes to the proper functioning of the&#xD;
        antioxidant defense system. In addition, this mineral protects cells against inflammation by&#xD;
        oxidative stress, because it acts in the stabilization of cell membrane. It also maintains&#xD;
        macrophage and neutrophil functions, natural killer cell activity, and complement activity.&#xD;
  &#xD;
        Matrix metalloproteinases (MMPs) are a family of zinc-containing endopeptidases and have the&#xD;
        main function of proteolytic degradation of connective tissue matrix proteins. Zinc prevents&#xD;
        (MMP-1) activation and inhibition of the T-cell accumulation in (OLP) through inhibiting of&#xD;
        (MMP-9).&#xD;
  &#xD;
        Aim of the study: To evaluate and compare the efficacy of adding oral zinc supplementation 50&#xD;
        mg to 0.1%Triamcinolone orabase (TA)versus 0.1%Triamcinolone orabase alone on the healing of&#xD;
        erosive OLP.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">January 5, 2023</start_date>
    <completion_date type="Actual">February 14, 2023</completion_date>
    <primary_completion_date type="Actual">February 14, 2023</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>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Change in oral lesions</measure>
      <time_frame>Baseline, 6 weeks, 12 weeks</time_frame>
      <description>Thongprasom scoring system will be used for the measurement of objective outcomes; score 5 was assigned to patients having white striae with erosive areas &gt;1 cm2, score 4 assigned to patients with white striae and erosive areas &lt;1 cm2, score 3 assigned to those having white striae and atrophic areas &gt;1 cm2, score 2 assigned to those having white striae and atrophic areas &lt;1 cm2, score 1 assigned to those having only white striae, and score 0 assigned to normal mucosa.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Change in MMP-9 level</measure>
      <time_frame>Baseline, 6 weeks, 12 weeks</time_frame>
      <description>Whole unstimulated saliva will be collected from all participants</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in pain</measure>
      <time_frame>Baseline, 6 weeks, 12 weeks</time_frame>
      <description>Patients will be asked to assign a numerical score representing the intensity of their symptoms on a scale from 0 to 10, with 0 being no symptoms and 10 being worst imaginable symptoms</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">22</enrollment>
    <condition>Oral Lichen Planus</condition>
    <arm_group>
      <arm_group_label>Test group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>control group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Oral zinc supplement</intervention_name>
      <description>patients received oral Zinc picolinate 50mg for 6 weeks as single morning dose along with 0.1%</description>
      <arm_group_label>Test group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>triamcinolone acetonide Oral paste</intervention_name>
      <description>patients will received 0.1%triamcinolone acetonide Oral paste twice daily alone for 6weeks.</description>
      <arm_group_label>control group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  All patients involved in this clinical trial will have symptomatic OLP&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Smokers or tobacco users will be excluded from this clinical trial.&#xD;
  &#xD;
            -  Pregnant and lactating females.&#xD;
  &#xD;
            -  Any patient that has history of cancer, kidney, liver or other autoimmune disease will&#xD;
               be excluded from this study.&#xD;
  &#xD;
            -  Patients showing dysplastic changes in their confirmatory biopsy specimen will be also&#xD;
               excluded.&#xD;
  &#xD;
            -  Any patients presenting with extra oral lichen planus lesions will be excluded.&#xD;
  &#xD;
            -  Suspicious lesions of both lichenoid contact reaction and lichenoid drug reaction&#xD;
               lesions will be excluded.&#xD;
  &#xD;
            -  Vitamin administration intake within the last 3 months&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>25 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>Alexandria Faculty of Dentistry</name>
        <address>
          <city>Alexandria</city>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 12, 2023</study_first_submitted>
    <study_first_submitted_qc>September 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 18, 2023</study_first_posted>
    <last_update_submitted>September 12, 2023</last_update_submitted>
    <last_update_submitted_qc>September 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 18, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Alexandria University</investigator_affiliation>
      <investigator_full_name>Hams Hamed Abdelrahman</investigator_full_name>
      <investigator_title>Assistant lecturer of DPH and Clinical statistician</investigator_title>
    </responsible_party>
    <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>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Triamcinolone</mesh_term>
      <mesh_term>Triamcinolone Acetonide</mesh_term>
      <mesh_term>Triamcinolone hexacetonide</mesh_term>
      <mesh_term>Triamcinolone diacetate</mesh_term>
    </intervention_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/NCT06042010
  org study id: Oral medicine_0424-04\2022
  nct id: NCT06042010
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  Lichen Planus (LP) is a chronic mucocutaneous inflammatory disease and considered as T-cell
        mediated autoimmune disorder.
  
        Zinc is a potent antioxidant micronutrient that contributes to the proper functioning of the
        antioxidant defense system. In addition, this mineral protects cells against inflammation by
        oxidative stress, because it acts in the stabilization of cell membrane. It also maintains
        macrophage and neutrophil functions, natural killer cell activity, and complement activity.
  
        Matrix metalloproteinases (MMPs) are a family of zinc-containing endopeptidases and have the
        main function of proteolytic degradation of connective tissue matrix proteins. Zinc prevents
        (MMP-1) activation and inhibition of the T-cell accumulation in (OLP) through inhibiting of
        (MMP-9).
  
        Aim of the study: To evaluate and compare the efficacy of adding oral zinc supplementation 50
        mg to 0.1%Triamcinolone orabase (TA)versus 0.1%Triamcinolone orabase alone on the healing of
        erosive OLP.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: None (Open Label)
  measure: Change in oral lesions
  time frame: Baseline, 6 weeks, 12 weeks
  description: Thongprasom scoring system will be used for the measurement of objective outcomes; score 5 was assigned to patients having white striae with erosive areas >1 cm2, score 4 assigned to patients with white striae and erosive areas <1 cm2, score 3 assigned to those having white striae and atrophic areas >1 cm2, score 2 assigned to those having white striae and atrophic areas <1 cm2, score 1 assigned to those having only white striae, and score 0 assigned to normal mucosa.
  measure: Change in MMP-9 level
  time frame: Baseline, 6 weeks, 12 weeks
  description: Whole unstimulated saliva will be collected from all participants
  measure: Change in pain
  time frame: Baseline, 6 weeks, 12 weeks
  description: Patients will be asked to assign a numerical score representing the intensity of their symptoms on a scale from 0 to 10, with 0 being no symptoms and 10 being worst imaginable symptoms
  arm group label: Test group
  arm group type: Experimental
  arm group label: control group
  arm group type: Active Comparator
  intervention type: Drug
  intervention name: Oral zinc supplement
  description: patients received oral Zinc picolinate 50mg for 6 weeks as single morning dose along with 0.1%
  arm group label: Test group
  intervention type: Drug
  intervention name: triamcinolone acetonide Oral paste
  description: patients will received 0.1%triamcinolone acetonide Oral paste twice daily alone for 6weeks.
  arm group label: control group
  criteria: 
  gender: All
  minimum age: 25 Years
  maximum age: N/A
  healthy volunteers: No
  facility: 
  country: Egypt
  responsible party type: Sponsor-Investigator
  investigator affiliation: Alexandria University
  investigator full name: Hams Hamed Abdelrahman
  investigator title: Assistant lecturer of DPH and Clinical statistician
  mesh term: Lichen Planus, Oral
  mesh term: Lichen Planus
  mesh term: Triamcinolone
  mesh term: Triamcinolone Acetonide
  mesh term: Triamcinolone hexacetonide
  mesh term: Triamcinolone diacetate