<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/NCT03026478</url>
  </required_header>
  <id_info>
    <org_study_id>PMVIDS&amp;RC/IEC/OMR/DN/0003-15</org_study_id>
    <nct_id>NCT03026478</nct_id>
  </id_info>
  <brief_title>Topical Betamethasone and Clobetasol in Orabase in Oral Lichen Planus</brief_title>
  <official_title>A Comparative Study on Clinical Efficacy of Clobetasol and Betamethasone in Orabase in Combination With Clotrimazole, in Oral Lichen Planus</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Garlapati Komali</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Panineeya Mahavidyalaya Institute of Dental Sciences &amp; Research Centre</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Oral Lichen Planus (OLP) is an autoimmune, chronic inflammatory mucocutaneous disease&#xD;
      characterized by pain and burning sensation. The major types of OLP are the following:&#xD;
      reticular, atrophic, erosive-ulcerative, bullous and pigmentous form.Its etiology remains&#xD;
      unclear. The presence of auto-cytotoxic T cell clones in the lesions suggests the role of&#xD;
      autoimmunity. Numerous treatment options of OLP include topical and systemic agents depending&#xD;
      on severity of lesions . Topical corticosteroids abide the mainstay of therapy,and are widely&#xD;
      accepted as the primary treatment of choice.Hence this study is designed to evaluate and&#xD;
      compare the clinical efficacy of topical Clobetasol 0.05% in orabase and Betamethasone 0.05%&#xD;
      in orabase in combination with Clotrimazole 1% in the management of symptomatic Oral Lichen&#xD;
      Planus.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patients of either sex, irrespective of age attending the Department of Oral Medicine &amp;&#xD;
      Radiology, Panineeya Mahavidhyalaya Institute of Dental Sciences and Research Centre,&#xD;
      Hyderabad who are clinically and histopathologically diagnosed with Oral Lichen Planus shall&#xD;
      be included in the study group after obtaining an informed consent from the patients.&#xD;
&#xD;
      Study design: Prospective study.&#xD;
&#xD;
      Sample size:&#xD;
&#xD;
      A total of 30 patients will be randomly divided into 2 groups with 15 patients in each group.&#xD;
&#xD;
      Methodology:&#xD;
&#xD;
      30 patients who are diagnosed with Oral Lichen Planus by clinical and histopathological&#xD;
      examination will be randomly assigned into 2 drug groups and burning sensation will be&#xD;
      assessed by VAS Scale and also clinical improvement will be assessed at interval of 1 week&#xD;
      till 4 weeks.&#xD;
&#xD;
      GROUP A: This group of patients will receive topical Clobetasol 0.05% in orabase and&#xD;
      Clotrimazole 1%.&#xD;
&#xD;
      GROUP B: This group of patients will receive topical Betamethasone 0.05% in orabase and&#xD;
      Clotrimazole 1%.&#xD;
&#xD;
      Inclusion criteria:&#xD;
&#xD;
        1. Patients with Oral Lichen Planus, who are willing to participate in the study.&#xD;
&#xD;
        2. Patients who are physically healthy and well oriented in time, space and as a person.&#xD;
&#xD;
        3. Patients clinically and histopathologically diagnosed with Oral Lichen Planus.&#xD;
&#xD;
        4. Patients with symptoms i.e. pain and burning sensation due to oral lichen planus.&#xD;
&#xD;
      Exclusion Criteria :&#xD;
&#xD;
        1. Patients with Oral Lichen Planus, who are not willing to participate in the study.&#xD;
&#xD;
        2. Patients with any other mucosal disease or any other skin disease which may be&#xD;
           associated with oral lesions.&#xD;
&#xD;
        3. Patients with a known allergy or contraindication to study medications.&#xD;
&#xD;
        4. Patients with systemic diseases, where steroids are contraindicated.&#xD;
&#xD;
        5. Pregnant women.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 6, 2016</start_date>
  <completion_date type="Anticipated">June 2018</completion_date>
  <primary_completion_date type="Anticipated">March 2018</primary_completion_date>
  <phase>Phase 2</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 (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Based on Visual analog scale and size of the lesion</measure>
    <time_frame>Each patient will be assessed for a total time frame of 1 month at a regular interval of 1 week.</time_frame>
    <description>study is in progress</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Oral Lichen Planus</condition>
  <arm_group>
    <arm_group_label>Betamethasone dipropionate 0.05%</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>topical Betamethasone dipropionate 0.05% in orabase with clotrimazole 1% in oral lichen planus two times a day for one month</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Clobetasol propionate 0.05%</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Topical Clobetasol propionate 0.05% in orabase with clotrimazole 1% in oral lichen planus patients two times a day for a month</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Betamethasone Dipropionate</intervention_name>
    <arm_group_label>Betamethasone dipropionate 0.05%</arm_group_label>
    <other_name>Betamethasone Dipropionate 0.05% gel</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Clobetasol Propionate</intervention_name>
    <arm_group_label>Clobetasol propionate 0.05%</arm_group_label>
    <other_name>Clobetasole Propionate 0.05% gel</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with Oral Lichen Planus, who are willing to participate in the study.&#xD;
&#xD;
          2. Patients who are physically healthy and well oriented in time, space and as a person.&#xD;
&#xD;
          3. Patients clinically and histopathologically diagnosed with Oral Lichen Planus.&#xD;
&#xD;
          4. Patients with symptoms i.e. pain and burning sensation due to oral lichen planus.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients with Oral Lichen Planus, who are not willing to participate in the study.&#xD;
&#xD;
          2. Patients with any other mucosal disease or any other skin disease which may be&#xD;
             associated with oral lesions.&#xD;
&#xD;
          3. Patients with a known allergy or contraindication to study medications.&#xD;
&#xD;
          4. Patients with known history of systemic diseases, where steroids are contraindicated.&#xD;
&#xD;
          5. Pregnant women.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>KOMALI GARLAPATI</last_name>
    <role>Principal Investigator</role>
    <affiliation>PMVIDS &amp; RC</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>KOMALI GARLAPATI, Professor</last_name>
    <phone>+918008884945</phone>
    <email>komali_garlapati@yahoo.co.in</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>PRATIMA SONI</last_name>
    <phone>+919030295070</phone>
    <email>sonipratima4@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Komali Garlapati</name>
      <address>
        <city>Hyderabad</city>
        <state>Telangana</state>
        <zip>500060</zip>
        <country>India</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>KOMALI GARLAPATI, M.D.S.</last_name>
      <phone>+918008884945</phone>
      <email>komali_garlapati@yahoo.co.in</email>
    </contact>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>January 17, 2017</study_first_submitted>
  <study_first_submitted_qc>January 19, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 20, 2017</study_first_posted>
  <last_update_submitted>March 13, 2018</last_update_submitted>
  <last_update_submitted_qc>March 13, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 14, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Panineeya Mahavidyalaya Institute of Dental Sciences &amp; Research Centre</investigator_affiliation>
    <investigator_full_name>Garlapati Komali</investigator_full_name>
    <investigator_title>PROFESSOR</investigator_title>
  </responsible_party>
  <keyword>oral lichen planus</keyword>
  <keyword>betamethasone</keyword>
  <keyword>clobetasol</keyword>
  <keyword>orabase</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>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Betamethasone</mesh_term>
    <mesh_term>Betamethasone Valerate</mesh_term>
    <mesh_term>Betamethasone-17,21-dipropionate</mesh_term>
    <mesh_term>Betamethasone benzoate</mesh_term>
    <mesh_term>Clobetasol</mesh_term>
    <mesh_term>Betamethasone sodium phosphate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03026478
org study id: PMVIDS&RC/IEC/OMR/DN/0003-15
nct id: NCT03026478
lead sponsor: 
has dmc: Yes
Oral Lichen Planus (OLP) is an autoimmune, chronic inflammatory mucocutaneous disease
      characterized by pain and burning sensation. The major types of OLP are the following:
      reticular, atrophic, erosive-ulcerative, bullous and pigmentous form.Its etiology remains
      unclear. The presence of auto-cytotoxic T cell clones in the lesions suggests the role of
      autoimmunity. Numerous treatment options of OLP include topical and systemic agents depending
      on severity of lesions . Topical corticosteroids abide the mainstay of therapy,and are widely
      accepted as the primary treatment of choice.Hence this study is designed to evaluate and
      compare the clinical efficacy of topical Clobetasol 0.05% in orabase and Betamethasone 0.05%
      in orabase in combination with Clotrimazole 1% in the management of symptomatic Oral Lichen
      Planus.
Patients of either sex, irrespective of age attending the Department of Oral Medicine &
      Radiology, Panineeya Mahavidhyalaya Institute of Dental Sciences and Research Centre,
      Hyderabad who are clinically and histopathologically diagnosed with Oral Lichen Planus shall
      be included in the study group after obtaining an informed consent from the patients.

      Study design: Prospective study.

      Sample size:

      A total of 30 patients will be randomly divided into 2 groups with 15 patients in each group.

      Methodology:

      30 patients who are diagnosed with Oral Lichen Planus by clinical and histopathological
      examination will be randomly assigned into 2 drug groups and burning sensation will be
      assessed by VAS Scale and also clinical improvement will be assessed at interval of 1 week
      till 4 weeks.

      GROUP A: This group of patients will receive topical Clobetasol 0.05% in orabase and
      Clotrimazole 1%.

      GROUP B: This group of patients will receive topical Betamethasone 0.05% in orabase and
      Clotrimazole 1%.

      Inclusion criteria:

        1. Patients with Oral Lichen Planus, who are willing to participate in the study.

        2. Patients who are physically healthy and well oriented in time, space and as a person.

        3. Patients clinically and histopathologically diagnosed with Oral Lichen Planus.

        4. Patients with symptoms i.e. pain and burning sensation due to oral lichen planus.

      Exclusion Criteria :

        1. Patients with Oral Lichen Planus, who are not willing to participate in the study.

        2. Patients with any other mucosal disease or any other skin disease which may be
           associated with oral lesions.

        3. Patients with a known allergy or contraindication to study medications.

        4. Patients with systemic diseases, where steroids are contraindicated.

        5. Pregnant women.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Based on Visual analog scale and size of the lesion
time frame: Each patient will be assessed for a total time frame of 1 month at a regular interval of 1 week.
description: study is in progress
arm group label: Betamethasone dipropionate 0.05%
arm group type: Experimental
description: topical Betamethasone dipropionate 0.05% in orabase with clotrimazole 1% in oral lichen planus two times a day for one month
arm group label: Clobetasol propionate 0.05%
arm group type: Active Comparator
description: Topical Clobetasol propionate 0.05% in orabase with clotrimazole 1% in oral lichen planus patients two times a day for a month
intervention type: Drug
intervention name: Betamethasone Dipropionate
arm group label: Betamethasone dipropionate 0.05%
other name: Betamethasone Dipropionate 0.05% gel
intervention type: Drug
intervention name: Clobetasol Propionate
arm group label: Clobetasol propionate 0.05%
other name: Clobetasole Propionate 0.05% gel
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: KOMALI GARLAPATI
role: Principal Investigator
affiliation: PMVIDS & RC
last name: KOMALI GARLAPATI, Professor
phone: +918008884945
email: komali_garlapati@yahoo.co.in
last name: PRATIMA SONI
phone: +919030295070
email: sonipratima4@gmail.com
facility: 
status: Recruiting
contact: 
country: India
responsible party type: Sponsor-Investigator
investigator affiliation: Panineeya Mahavidyalaya Institute of Dental Sciences & Research Centre
investigator full name: Garlapati Komali
investigator title: PROFESSOR
mesh term: Lichen Planus, Oral
mesh term: Lichen Planus
mesh term: Betamethasone
mesh term: Betamethasone Valerate
mesh term: Betamethasone-17,21-dipropionate
mesh term: Betamethasone benzoate
mesh term: Clobetasol
mesh term: Betamethasone sodium phosphate
sharing ipd: No