<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/NCT04442633</url>
  </required_header>
  <id_info>
    <org_study_id>Glutamine and lichen planus</org_study_id>
    <nct_id>NCT04442633</nct_id>
  </id_info>
  <brief_title>Glutamine With Topical Corticosteroids for Lichen Planus Treatment</brief_title>
  <official_title>Clinical Evaluation of Glutamine Combined With Topical Corticosteroids in the Treatment of Erosive Oral Lichen Planus</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 an inflammatory skin disease of unknown etiology. Glutamine promotes&#xD;
      protein and collagen synthesis, imparts immunity, and maintains the alimentary canal mucosa&#xD;
      structure.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Lichen planus (LP) is an inflammatory skin disease of unknown etiology. Recently, increased&#xD;
      oxidative stress has been implicated in the pathogenesis of erosive oral lichen planus&#xD;
      (EOLP). Glutamine is a source of energy for fibroblasts, immunocompetent cells, and&#xD;
      intestinal epithelial cells involved in collagen production. It promotes protein and collagen&#xD;
      synthesis, imparts immunity, and maintains the alimentary canal mucosa structure.&#xD;
&#xD;
      The aim of this study is to evaluate the effect of Glutamine combined with topical&#xD;
      corticosteroid in the treatment of oral erosive LP.&#xD;
&#xD;
      Thirty patients with a confirmed clinical and histopathologic diagnosis of OLP recruited in&#xD;
      this study and divided into 2 equal groups, each consisting of 15 subjects. Group 1 consists&#xD;
      of patients treated with topical steroids plus antifungal (conventional therapy); Group 2&#xD;
      consists of patients treated with Glutamine combined with topical steroids plus antifungal.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 1, 2019</start_date>
  <completion_date type="Actual">January 1, 2020</completion_date>
  <primary_completion_date type="Actual">August 1, 2019</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>Change in oral lichen planus lesions severity</measure>
    <time_frame>at baseline, 1 months and 3 months</time_frame>
    <description>Mucosal lesion severity score 0: no lesion score 1: white lesion score 2:atrophy/erosion intermixed or not with white lesion score 3: ulceration intermixed or not with white lesion</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in pain level</measure>
    <time_frame>at baseline, 1 months and 3 months</time_frame>
    <description>Pain score score 0= no pain score 1= mild score 2= moderate score 3= severe</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Lichen Penis Planus</condition>
  <arm_group>
    <arm_group_label>conventional therapy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>topical corticosteroid plus antifungal</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Glutamine with a topical corticosteroid plus antifungal</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Glutamine therapy in combination with a topical corticosteroid plus antifungal</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Glutamine Cap/Tab</intervention_name>
    <description>Glutamine Capsules: One capsule three times daily on an empty stomach for one month</description>
    <arm_group_label>Glutamine with a topical corticosteroid plus antifungal</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Miconazole Oral gel</intervention_name>
    <description>Miconazole oral gel: applied three to four times daily for three weeks</description>
    <arm_group_label>Glutamine with a topical corticosteroid plus antifungal</arm_group_label>
    <arm_group_label>conventional therapy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Kenacort in orabase</intervention_name>
    <description>Kenacort in orabase: applied two to three times a day for 3 weeks followed by tapering the following 9 weeks until a maintenance dose of two to three times a week is reached</description>
    <arm_group_label>Glutamine with a topical corticosteroid plus antifungal</arm_group_label>
    <arm_group_label>conventional therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients clinically and histopathologically diagnosed to be suffering from EOLP.&#xD;
&#xD;
          2. Patients who had symptoms i.e. pain and/or burning sensation secondary to EOLP.&#xD;
&#xD;
          3. Patients under stressful life conditions as evidenced by ISMA-UK Stress Questionnaire&#xD;
&#xD;
          4. Males and Females with an age ranging from 30-60years&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients suspected to have a lichenoid drug reaction or lichenoid contact allergy.&#xD;
&#xD;
          2. Patients suffering from any systemic diseases (such as diabetes, cardiovascular, liver&#xD;
             disorder, renal dysfunction)&#xD;
&#xD;
          3. Patients with findings of any physical or mental abnormality which would interfere&#xD;
             with or be affected by the study procedure.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>30 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Outpatient Clinic of Oral medicine Department, Faculty of Dentistry, Alexandria University, Egypt</name>
      <address>
        <city>Alexandria</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 18, 2020</study_first_submitted>
  <study_first_submitted_qc>June 19, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 22, 2020</study_first_posted>
  <last_update_submitted>June 19, 2020</last_update_submitted>
  <last_update_submitted_qc>June 19, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 22, 2020</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</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lichen Planus</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Miconazole</mesh_term>
  </intervention_browse>
  <!-- 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/NCT04442633
org study id: Glutamine and lichen planus
nct id: NCT04442633
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Lichen planus (LP) is an inflammatory skin disease of unknown etiology. Glutamine promotes
      protein and collagen synthesis, imparts immunity, and maintains the alimentary canal mucosa
      structure.
Lichen planus (LP) is an inflammatory skin disease of unknown etiology. Recently, increased
      oxidative stress has been implicated in the pathogenesis of erosive oral lichen planus
      (EOLP). Glutamine is a source of energy for fibroblasts, immunocompetent cells, and
      intestinal epithelial cells involved in collagen production. It promotes protein and collagen
      synthesis, imparts immunity, and maintains the alimentary canal mucosa structure.

      The aim of this study is to evaluate the effect of Glutamine combined with topical
      corticosteroid in the treatment of oral erosive LP.

      Thirty patients with a confirmed clinical and histopathologic diagnosis of OLP recruited in
      this study and divided into 2 equal groups, each consisting of 15 subjects. Group 1 consists
      of patients treated with topical steroids plus antifungal (conventional therapy); Group 2
      consists of patients treated with Glutamine combined with topical steroids plus antifungal.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Change in oral lichen planus lesions severity
time frame: at baseline, 1 months and 3 months
description: Mucosal lesion severity score 0: no lesion score 1: white lesion score 2:atrophy/erosion intermixed or not with white lesion score 3: ulceration intermixed or not with white lesion
measure: Change in pain level
time frame: at baseline, 1 months and 3 months
description: Pain score score 0= no pain score 1= mild score 2= moderate score 3= severe
arm group label: conventional therapy
arm group type: Active Comparator
description: topical corticosteroid plus antifungal
arm group label: Glutamine with a topical corticosteroid plus antifungal
arm group type: Experimental
description: Glutamine therapy in combination with a topical corticosteroid plus antifungal
intervention type: Drug
intervention name: Glutamine Cap/Tab
description: Glutamine Capsules: One capsule three times daily on an empty stomach for one month
arm group label: Glutamine with a topical corticosteroid plus antifungal
intervention type: Drug
intervention name: Miconazole Oral gel
description: Miconazole oral gel: applied three to four times daily for three weeks
arm group label: Glutamine with a topical corticosteroid plus antifungal
arm group label: conventional therapy
intervention type: Drug
intervention name: Kenacort in orabase
description: Kenacort in orabase: applied two to three times a day for 3 weeks followed by tapering the following 9 weeks until a maintenance dose of two to three times a week is reached
arm group label: Glutamine with a topical corticosteroid plus antifungal
arm group label: conventional therapy
criteria: 
gender: All
minimum age: 30 Years
maximum age: 60 Years
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
mesh term: Lichen Planus
mesh term: Miconazole