<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/NCT04503746</url>
  </required_header>
  <id_info>
    <org_study_id>AL102-PDT</org_study_id>
    <nct_id>NCT04503746</nct_id>
  </id_info>
  <brief_title>A Study to Evaluate the Efficacy and Safety of ALH-L1005 in Patients With Chronic Periodontitis</brief_title>
  <official_title>A Multi-center, Randomized, Double-Blind, Phase II Clinical Trial to Evaluate the Efficacy and Safety of 12-week Treatment of ALH-L1005 600 mg or 1200 mg in Patients With Chronic Periodontitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>AngioLab, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>AngioLab, Inc.</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>
      The main objective of this study is to evaluate efficacy and safety of ALH-L1005 in patients&#xD;
      with chronic periodontitis&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">July 16, 2020</start_date>
  <completion_date type="Actual">December 13, 2021</completion_date>
  <primary_completion_date type="Actual">December 13, 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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in Pocket Depth(PD)</measure>
    <time_frame>baseline, 12 weeks</time_frame>
    <description>Change in Pocket Depth in Subjects</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Change in Pocket Depth(PD)</measure>
    <time_frame>baseline, 4 weeks, 8 weeks</time_frame>
    <description>Change in Pocket Depth in Subjects</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Clinical Attachment Level(CAL)</measure>
    <time_frame>baseline, 4 weeks, 8 weeks, 12 weeks</time_frame>
    <description>Change in Clinical Attachment Level in Subjects</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Gingival recession(GR)</measure>
    <time_frame>baseline, 12 weeks</time_frame>
    <description>Change in Gingival recession in Subjects</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in Bleeding on probing(BOP) score</measure>
    <time_frame>baseline, 12 weeks</time_frame>
    <description>Change in Bleeding on probing score in Subjects</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">117</enrollment>
  <condition>Chronic Periodontitis</condition>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Placebo twice a day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ALH-L1005 600 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ALH-L1005 300 mg twice a day</description>
  </arm_group>
  <arm_group>
    <arm_group_label>ALH-L1005 1,200 mg</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>ALH-L1005 600 mg twice a day</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ALH-L1005 600mg/day</intervention_name>
    <description>ALH-L1005 300mg 2 tablet and placebo 2 tablet</description>
    <arm_group_label>ALH-L1005 600 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ALH-L1005 1,200mg/day</intervention_name>
    <description>ALH-L1005 300mg 4 tablet</description>
    <arm_group_label>ALH-L1005 1,200 mg</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Placebo</intervention_name>
    <description>Placebo 4 tablet</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Men or women ages 18 and over, under 79 years of age&#xD;
&#xD;
          -  Patients diagnosed with chronic periodontitis&#xD;
&#xD;
          -  Patients with 4 teeth and over whose pocket depth is ≥ 4 mm and clinical attachment&#xD;
             level is ≥ 3 mm&#xD;
&#xD;
          -  Patients who are voluntarily participated in clinical trial&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  History of antibiotic therapy within the 1 month prior to study&#xD;
&#xD;
          -  Those who had undergone any dental surgical or non-surgical therapy within 3 months&#xD;
             prior to the start of the study&#xD;
&#xD;
          -  Subjects who are pregnant/ lactating&#xD;
&#xD;
          -  Smokers&#xD;
&#xD;
          -  Patients who take Anticoagulants or Antiplatelet Agents&#xD;
&#xD;
          -  With Systemic diseases that affect periodontal conditions such as: diabetes,&#xD;
             hypertension and diseases of immune system&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>78 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>AngioLab, Inc.</name>
      <address>
        <city>Daejeon</city>
        <state>Daejeon Gwangyeogsi</state>
        <zip>34015</zip>
        <country>Korea, Republic of</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Korea, Republic of</country>
  </location_countries>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>August 5, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 7, 2020</study_first_posted>
  <last_update_submitted>August 9, 2022</last_update_submitted>
  <last_update_submitted_qc>August 9, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>periodontitis</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontitis</mesh_term>
    <mesh_term>Chronic Periodontitis</mesh_term>
  </condition_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/NCT04503746
org study id: AL102-PDT
nct id: NCT04503746
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
The main objective of this study is to evaluate efficacy and safety of ALH-L1005 in patients
      with chronic periodontitis
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Change in Pocket Depth(PD)
time frame: baseline, 12 weeks
description: Change in Pocket Depth in Subjects
measure: Change in Pocket Depth(PD)
time frame: baseline, 4 weeks, 8 weeks
description: Change in Pocket Depth in Subjects
measure: Change in Clinical Attachment Level(CAL)
time frame: baseline, 4 weeks, 8 weeks, 12 weeks
description: Change in Clinical Attachment Level in Subjects
measure: Change in Gingival recession(GR)
time frame: baseline, 12 weeks
description: Change in Gingival recession in Subjects
measure: Change in Bleeding on probing(BOP) score
time frame: baseline, 12 weeks
description: Change in Bleeding on probing score in Subjects
arm group label: Placebo
arm group type: Placebo Comparator
description: Placebo twice a day
arm group label: ALH-L1005 600 mg
arm group type: Experimental
description: ALH-L1005 300 mg twice a day
arm group label: ALH-L1005 1,200 mg
arm group type: Experimental
description: ALH-L1005 600 mg twice a day
intervention type: Drug
intervention name: ALH-L1005 600mg/day
description: ALH-L1005 300mg 2 tablet and placebo 2 tablet
arm group label: ALH-L1005 600 mg
intervention type: Drug
intervention name: ALH-L1005 1,200mg/day
description: ALH-L1005 300mg 4 tablet
arm group label: ALH-L1005 1,200 mg
intervention type: Drug
intervention name: Placebo
description: Placebo 4 tablet
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 78 Years
healthy volunteers: No
facility: 
country: Korea, Republic of
responsible party type: Sponsor
mesh term: Periodontitis
mesh term: Chronic Periodontitis
sharing ipd: No