<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/NCT03265093</url>
  </required_header>
  <id_info>
    <org_study_id>EbSAGLAM2</org_study_id>
    <nct_id>NCT03265093</nct_id>
  </id_info>
  <brief_title>Use of Injectable Platelet Rich Fibrin in Lichen Planus</brief_title>
  <official_title>Current Approach in the Treatment of Lichen Planus: Injectable Platelet Rich Fibrin ((İ-PRF)</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Bezmialem Vakif University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Bezmialem Vakif University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Platelet Rich Fibrine (PRF), which promotes wound healing by supporting angiogenesis,&#xD;
      immunity and epithelial proliferation phases. over a decade has since past since PRF was&#xD;
      developed and many clinicians now point to the potential use of a liquid version of PRF. a&#xD;
      liquid injectable-platelet-rich fibrin (i-PRF) was developed by modifying spin centrifugation&#xD;
      forces. At lower centrifugation speeds and by utilizing non-glass centrifugation tubes, the&#xD;
      fibrin coagulation could be slowed down at early time points thus generating an injectable&#xD;
      PRF. Much like traditional PRF, i-PRF contains an increase in leukocyte number and is further&#xD;
      able to stimulate growth factor release.&#xD;
&#xD;
      Lichen planus is a common chronic mucocutaneous inflammatory disorder which generally affect&#xD;
      s middle aged adults. Therapeutic methods including topical and systemic corticosteroids for&#xD;
      the treatment of oral lichen planus (OLP) are suggested. However, long&#xD;
&#xD;
      -term use of corticosteroids may be associated with local and systemic complications, and&#xD;
      moreover, some patients may not be responsive.&#xD;
&#xD;
      The investigators aimed to apply a treatment of autogenous origin (including no foreign&#xD;
      products), considering the side effects of our corticosteroids. The study was designed as a&#xD;
      split mouth.&#xD;
&#xD;
      The investigators planned to administer I-PRF to one side and intralesional corticosteroid&#xD;
      therapy to the other side at patients with bilateral atrophic / erosive oral lichen planus&#xD;
      lesions&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Lichen planus diagnosis will be made histopathologically. Intraoral photographs and&#xD;
      measurements will be taken at the beginning of the treatment and 2 months after the treatment&#xD;
      is finished.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 3, 2017</start_date>
  <completion_date type="Actual">September 2, 2019</completion_date>
  <primary_completion_date type="Actual">September 2, 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>
    <intervention_model_description>Blinded, Parallel group, randomized controlled trial</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Investigator)</masking>
    <masking_description>Investigator, Outcomes Assessor</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Visual Analog Scale</measure>
    <time_frame>6 months</time_frame>
    <description>Patients were asked to grade the severity of their symptoms in numbers from 1(very mild pain) to 100 (very sever pain) on the visual analog scale in each visit.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Thongprasom sign scoring system</measure>
    <time_frame>6 months</time_frame>
    <description>The lesions were evaluated according to Thongprasom sign scoring system</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Oral Health- Related Quality of Life index (OHIP-14)</measure>
    <time_frame>6 months</time_frame>
    <description>Patients were asked to grade the Oral Health- Related Quality of Life index</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Oral Hygiene Index</measure>
    <time_frame>6 months</time_frame>
    <description>Oral Hygiene Index were evaluated.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Lichen Planus</condition>
  <arm_group>
    <arm_group_label>experimental; Corticosteroid</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Intralesional corticosteroid administration</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Experimental; Injectable Platelet rich fibrin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Injectable Platelet rich fibrin</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Platelet Rich Fibrin Injection</intervention_name>
    <description>Venous blood will be taken from the patient every session and I-PRF will be created in the centrifuge. I- prf will be injected on one side and corticosteroid will be injected on the other side in patients with bilateral oral lichen planus. Once a week in the first month after treatment and one time at the end of the second month, the patient will be called to the control.</description>
    <arm_group_label>Experimental; Injectable Platelet rich fibrin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Corticosteroid</intervention_name>
    <description>Corticosteroid injection</description>
    <arm_group_label>experimental; Corticosteroid</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Oral erosive lesions were diagnosed according to Andreasen classification.&#xD;
&#xD;
          2. Histological confirmation of erosive OLP according to the World Health Organization's&#xD;
             clinicopathological diagnostic criteria for OLP.&#xD;
&#xD;
          3. No previous treatment of oral lichen planus at least 3 months.&#xD;
&#xD;
          4. Willingness and ability to complete the present clinical trial.&#xD;
&#xD;
          5. Patients of ages above 18 years old without skin involvement.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Histological signs of dysplasia.&#xD;
&#xD;
          2. Using drugs associated with lichenoid reaction.&#xD;
&#xD;
          3. Pregnant, lactating and smoker patients.&#xD;
&#xD;
          4. Patient with systemic diseases such as diabetes mellitus, immunodysfunction,&#xD;
             hematological and hepatological patients or had photosensitivity history.&#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>Ebru Sağlam, PhD</last_name>
    <role>Study Chair</role>
    <affiliation>Bezmialem Vakif University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Mustafa Tunalı, Assoc. prof.</last_name>
    <role>Study Director</role>
    <affiliation>Bezmialem VakifUniversity</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Tuğba Ünver, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bezmialem Vakif University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Zeliha Betül Özsağır</last_name>
    <role>Principal Investigator</role>
    <affiliation>Bezmialem Vakif University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ebru SAĞLAM</name>
      <address>
        <city>İstanbul</city>
        <state>Fatih</state>
        <zip>34093</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>August 25, 2017</study_first_submitted>
  <study_first_submitted_qc>August 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 29, 2017</study_first_posted>
  <last_update_submitted>May 27, 2020</last_update_submitted>
  <last_update_submitted_qc>May 27, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 28, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Pain Measurement</keyword>
  <keyword>Platelet Activation</keyword>
  <keyword>Quality of Life</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Lichen Planus</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03265093
org study id: EbSAGLAM2
nct id: NCT03265093
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Platelet Rich Fibrine (PRF), which promotes wound healing by supporting angiogenesis,
      immunity and epithelial proliferation phases. over a decade has since past since PRF was
      developed and many clinicians now point to the potential use of a liquid version of PRF. a
      liquid injectable-platelet-rich fibrin (i-PRF) was developed by modifying spin centrifugation
      forces. At lower centrifugation speeds and by utilizing non-glass centrifugation tubes, the
      fibrin coagulation could be slowed down at early time points thus generating an injectable
      PRF. Much like traditional PRF, i-PRF contains an increase in leukocyte number and is further
      able to stimulate growth factor release.

      Lichen planus is a common chronic mucocutaneous inflammatory disorder which generally affect
      s middle aged adults. Therapeutic methods including topical and systemic corticosteroids for
      the treatment of oral lichen planus (OLP) are suggested. However, long

      -term use of corticosteroids may be associated with local and systemic complications, and
      moreover, some patients may not be responsive.

      The investigators aimed to apply a treatment of autogenous origin (including no foreign
      products), considering the side effects of our corticosteroids. The study was designed as a
      split mouth.

      The investigators planned to administer I-PRF to one side and intralesional corticosteroid
      therapy to the other side at patients with bilateral atrophic / erosive oral lichen planus
      lesions
Lichen planus diagnosis will be made histopathologically. Intraoral photographs and
      measurements will be taken at the beginning of the treatment and 2 months after the treatment
      is finished.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Blinded, Parallel group, randomized controlled trial
primary purpose: Treatment
masking: Single (Investigator)
masking description: Investigator, Outcomes Assessor
measure: Visual Analog Scale
time frame: 6 months
description: Patients were asked to grade the severity of their symptoms in numbers from 1(very mild pain) to 100 (very sever pain) on the visual analog scale in each visit.
measure: Thongprasom sign scoring system
time frame: 6 months
description: The lesions were evaluated according to Thongprasom sign scoring system
measure: Oral Health- Related Quality of Life index (OHIP-14)
time frame: 6 months
description: Patients were asked to grade the Oral Health- Related Quality of Life index
measure: Oral Hygiene Index
time frame: 6 months
description: Oral Hygiene Index were evaluated.
arm group label: experimental; Corticosteroid
arm group type: Active Comparator
description: Intralesional corticosteroid administration
arm group label: Experimental; Injectable Platelet rich fibrin
arm group type: Experimental
description: Injectable Platelet rich fibrin
intervention type: Other
intervention name: Platelet Rich Fibrin Injection
description: Venous blood will be taken from the patient every session and I-PRF will be created in the centrifuge. I- prf will be injected on one side and corticosteroid will be injected on the other side in patients with bilateral oral lichen planus. Once a week in the first month after treatment and one time at the end of the second month, the patient will be called to the control.
arm group label: Experimental; Injectable Platelet rich fibrin
intervention type: Drug
intervention name: Corticosteroid
description: Corticosteroid injection
arm group label: experimental; Corticosteroid
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Ebru Sağlam, PhD
role: Study Chair
affiliation: Bezmialem Vakif University
last name: Mustafa Tunalı, Assoc. prof.
role: Study Director
affiliation: Bezmialem VakifUniversity
last name: Tuğba Ünver, PhD
role: Principal Investigator
affiliation: Bezmialem Vakif University
last name: Zeliha Betül Özsağır
role: Principal Investigator
affiliation: Bezmialem Vakif University
facility: 
country: Turkey
responsible party type: Sponsor
mesh term: Lichen Planus
sharing ipd: Undecided