<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/NCT03293368</url>
  </required_header>
  <id_info>
    <org_study_id>PRP-olp</org_study_id>
    <nct_id>NCT03293368</nct_id>
  </id_info>
  <brief_title>Efficacy of Intralesional Injection of Platelet Rich Plasma in the Treatment of Patients With Erosive Oral Lichen Planus</brief_title>
  <official_title>Efficacy of Intralesional Injection of Autologous Platelet Rich Plasma Versus Intralesional Injection of Corticosteroids on Pain Relief and Ulcers Healing in Patients With Erosive Oral Lichen Planus; Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>No</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>
      After signing the informed consent, the participant will be allocated to either intervention&#xD;
      or control group, then each participant in the intervention group will receive intralesional&#xD;
      injections of platelet rich plasma extracted from their own blood in each visit as following:&#xD;
&#xD;
        1. 12 ml of blood will be assembled from the veins of antecubital fossa&#xD;
&#xD;
        2. PRP preparation will be done according to Mostafa et al., 2013&#xD;
&#xD;
        3. 0.5 ml of PRP will be injected per 1 cm2 of ulcerated mucosa&#xD;
&#xD;
      The second group will receive triamcinolone acetonide 40 mg injected 1 ml per 1 cm2 of&#xD;
      ulcerated mucosa&#xD;
&#xD;
      Both groups will receive a total of 4 injection, the injections will be carried out once a&#xD;
      week.&#xD;
&#xD;
      Pain, lesions size and remission time are the outcomes will be assessed using a numerical&#xD;
      rating scale (Seymour, 1982), clinical score according to Thongprasom et al., 1992 and binary&#xD;
      scale for remission time according to Conrotto et al., 2006, respectively.&#xD;
&#xD;
      Assessment of the outcomes will be carried before the trial (baseline records) and before&#xD;
      receiving the treatment in each visit by the primary investigator (H.A.) and the blinded&#xD;
      assessor (Dr. A.W.) separately.&#xD;
&#xD;
      Each participant will have a total of 11 visits during the trial, 5 visits will be once every&#xD;
      week during the trial and every 2 weeks for 3 months treatment free.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 1, 2018</start_date>
  <completion_date type="Actual">January 1, 2021</completion_date>
  <primary_completion_date type="Actual">January 1, 2021</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 (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Reported Pain</measure>
    <time_frame>3 months</time_frame>
    <description>Pain and burning sensation assessed using Numerical rating scale</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Clinical score</measure>
    <time_frame>3 months</time_frame>
    <description>Clinical score using a 5 grades scoring system described by Thongprasom et al.,1992</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Remission time</measure>
    <time_frame>3 months</time_frame>
    <description>Time until flare up of the disease occur using a binary scale (Stable/Not stable) described by Conrotto et al., 2006</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">20</enrollment>
  <condition>Erosive Oral Lichen Planus</condition>
  <arm_group>
    <arm_group_label>Platelet rich plasma</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>0.5 ml of autologous platelet rich plasma prepared using a double spin technique described by Mostafa et al., 2013 will be injected in the center of eroded oral mucosa in patients suffering from oral lichen planus.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Croticosteroids</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>0.5 ml of triamcinolone acetonide 40 mg will be injected in the center of eroded oral mucosa in patients suffering from oral lichen planus.</description>
  </arm_group>
  <intervention>
    <intervention_type>Biological</intervention_type>
    <intervention_name>Platelet rich plasma</intervention_name>
    <description>Platelet rich plasma will be prepared from the patients own blood in the same visit using a double spin technique, then 0.5 ml of PRP will be injected per 1 cm2 of eroded oral mucosa.</description>
    <arm_group_label>Platelet rich plasma</arm_group_label>
    <other_name>Platelet rich in growth factors</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Triamcinolone Acetonide</intervention_name>
    <description>0.5 ml of triamcinolone acetonide 40mg will be injected per 1 cm2 of eroded oral mucosa</description>
    <arm_group_label>Croticosteroids</arm_group_label>
    <other_name>Corticosteroids, Steroids</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients presenting with a clinical picture that assumes the diagnosis of erosive oral&#xD;
             lichen planus (bilateral, more or less symmetrical erosive lesions with lacelike&#xD;
             network of slightly raised gray white lesions (reticular pattern), and a histological&#xD;
             findings that confirms the diagnosis (liquefaction degeneration of the basal cell&#xD;
             layer with irregular-saw teeth like rete pegs.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Systemic disorders such as hematological diseases, severe cardiovascular diseases,&#xD;
             treatment with any drugs that could cause Lichenoid reaction.&#xD;
&#xD;
          -  Pregnancy or active breastfeeding&#xD;
&#xD;
          -  Patients who had lesion/lesions with dysplasia&#xD;
&#xD;
          -  Patients who received topical treatment for Oral Lichen planus in the last 2 weeks&#xD;
             (Lee et al., 2013) or systemic treatment for OLP in the past 3 months.&#xD;
&#xD;
          -  Platelet count &lt; 150,000/mm3; Hgb &lt; 11 g/dl.&#xD;
&#xD;
          -  Immunosuppressed patients&#xD;
&#xD;
          -  Patients receiving therapy with anticoagulants and use of non-steroidal&#xD;
             anti-inflammatory drugs in the 5 days before taking the blood sample.&#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>Soheir Gaafar, Professor</last_name>
    <role>Study Chair</role>
    <affiliation>Professor of oral medicine, diagnosis and periodontology. Faculty of Dentistry. Cairo University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of Dentistry</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>February 2023</verification_date>
  <study_first_submitted>September 19, 2017</study_first_submitted>
  <study_first_submitted_qc>September 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 26, 2017</study_first_posted>
  <last_update_submitted>February 7, 2023</last_update_submitted>
  <last_update_submitted_qc>February 7, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">February 9, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Abdelhameed Hamid Mohammad Hijazi</investigator_full_name>
    <investigator_title>PhD Student</investigator_title>
  </responsible_party>
  <keyword>Oral</keyword>
  <keyword>Lichen planus</keyword>
  <keyword>PRP</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>Triamcinolone</mesh_term>
    <mesh_term>Triamcinolone Acetonide</mesh_term>
    <mesh_term>Triamcinolone hexacetonide</mesh_term>
    <mesh_term>Triamcinolone diacetate</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>September 20, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/68/NCT03293368/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03293368
org study id: PRP-olp
nct id: NCT03293368
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
After signing the informed consent, the participant will be allocated to either intervention
      or control group, then each participant in the intervention group will receive intralesional
      injections of platelet rich plasma extracted from their own blood in each visit as following:

        1. 12 ml of blood will be assembled from the veins of antecubital fossa

        2. PRP preparation will be done according to Mostafa et al., 2013

        3. 0.5 ml of PRP will be injected per 1 cm2 of ulcerated mucosa

      The second group will receive triamcinolone acetonide 40 mg injected 1 ml per 1 cm2 of
      ulcerated mucosa

      Both groups will receive a total of 4 injection, the injections will be carried out once a
      week.

      Pain, lesions size and remission time are the outcomes will be assessed using a numerical
      rating scale (Seymour, 1982), clinical score according to Thongprasom et al., 1992 and binary
      scale for remission time according to Conrotto et al., 2006, respectively.

      Assessment of the outcomes will be carried before the trial (baseline records) and before
      receiving the treatment in each visit by the primary investigator (H.A.) and the blinded
      assessor (Dr. A.W.) separately.

      Each participant will have a total of 11 visits during the trial, 5 visits will be once every
      week during the trial and every 2 weeks for 3 months treatment free.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Reported Pain
time frame: 3 months
description: Pain and burning sensation assessed using Numerical rating scale
measure: Clinical score
time frame: 3 months
description: Clinical score using a 5 grades scoring system described by Thongprasom et al.,1992
measure: Remission time
time frame: 3 months
description: Time until flare up of the disease occur using a binary scale (Stable/Not stable) described by Conrotto et al., 2006
arm group label: Platelet rich plasma
arm group type: Experimental
description: 0.5 ml of autologous platelet rich plasma prepared using a double spin technique described by Mostafa et al., 2013 will be injected in the center of eroded oral mucosa in patients suffering from oral lichen planus.
arm group label: Croticosteroids
arm group type: Active Comparator
description: 0.5 ml of triamcinolone acetonide 40 mg will be injected in the center of eroded oral mucosa in patients suffering from oral lichen planus.
intervention type: Biological
intervention name: Platelet rich plasma
description: Platelet rich plasma will be prepared from the patients own blood in the same visit using a double spin technique, then 0.5 ml of PRP will be injected per 1 cm2 of eroded oral mucosa.
arm group label: Platelet rich plasma
other name: Platelet rich in growth factors
intervention type: Drug
intervention name: Triamcinolone Acetonide
description: 0.5 ml of triamcinolone acetonide 40mg will be injected per 1 cm2 of eroded oral mucosa
arm group label: Croticosteroids
other name: Corticosteroids, Steroids
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: No
last name: Soheir Gaafar, Professor
role: Study Chair
affiliation: Professor of oral medicine, diagnosis and periodontology. Faculty of Dentistry. Cairo University
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Abdelhameed Hamid Mohammad Hijazi
investigator title: PhD Student
mesh term: Lichen Planus, Oral
mesh term: Lichen Planus
mesh term: Triamcinolone
mesh term: Triamcinolone Acetonide
mesh term: Triamcinolone hexacetonide
mesh term: Triamcinolone diacetate
sharing ipd: Undecided
provided document: 