A Study to Evaluate the Efficacy and Safety of ALH-L1005 in Patients With Chronic Periodontitis

August 9, 2022 updated by: AngioLab, Inc.

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

The main objective of this study is to evaluate efficacy and safety of ALH-L1005 in patients with chronic periodontitis

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

117

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
    • Daejeon Gwangyeogsi
      • Daejeon, Daejeon Gwangyeogsi, Korea, Republic of, 34015
        • AngioLab, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 78 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Men or women ages 18 and over, under 79 years of age
  • Patients diagnosed with chronic periodontitis
  • Patients with 4 teeth and over whose pocket depth is ≥ 4 mm and clinical attachment level is ≥ 3 mm
  • Patients who are voluntarily participated in clinical trial

Exclusion Criteria:

  • History of antibiotic therapy within the 1 month prior to study
  • Those who had undergone any dental surgical or non-surgical therapy within 3 months prior to the start of the study
  • Subjects who are pregnant/ lactating
  • Smokers
  • Patients who take Anticoagulants or Antiplatelet Agents
  • With Systemic diseases that affect periodontal conditions such as: diabetes, hypertension and diseases of immune system

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
Placebo twice a day
Drug: Placebo
Placebo 4 tablet
EXPERIMENTAL: ALH-L1005 600 mg
ALH-L1005 300 mg twice a day
Drug: ALH-L1005 600mg/day
ALH-L1005 300mg 2 tablet and placebo 2 tablet
EXPERIMENTAL: ALH-L1005 1,200 mg
ALH-L1005 600 mg twice a day
Drug: ALH-L1005 1,200mg/day
ALH-L1005 300mg 4 tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pocket Depth(PD)
Time Frame: baseline, 12 weeks
Change in Pocket Depth in Subjects
baseline, 12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Pocket Depth(PD)
Time Frame: baseline, 4 weeks, 8 weeks
Change in Pocket Depth in Subjects
baseline, 4 weeks, 8 weeks
Change in Clinical Attachment Level(CAL)
Time Frame: baseline, 4 weeks, 8 weeks, 12 weeks
Change in Clinical Attachment Level in Subjects
baseline, 4 weeks, 8 weeks, 12 weeks
Change in Gingival recession(GR)
Time Frame: baseline, 12 weeks
Change in Gingival recession in Subjects
baseline, 12 weeks
Change in Bleeding on probing(BOP) score
Time Frame: baseline, 12 weeks
Change in Bleeding on probing score in Subjects
baseline, 12 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AngioLab, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

July 16, 2020

Primary Completion (ACTUAL)

December 13, 2021

Study Completion (ACTUAL)

December 13, 2021

Study Registration Dates

First Submitted

August 5, 2020

First Submitted That Met QC Criteria

August 5, 2020

First Posted (ACTUAL)

August 7, 2020

Study Record Updates

Last Update Posted (ACTUAL)

August 11, 2022

Last Update Submitted That Met QC Criteria

August 9, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • AL102-PDT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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