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

Primary Purpose

Chronic Periodontitis

Status

Completed

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

ALH-L1005 600mg/day

ALH-L1005 1,200mg/day

Placebo

About this trial

This is an interventional treatment trial for Chronic Periodontitis focused on measuring periodontitis

Eligibility Criteria

18 Years - 78 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

AngioLab, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

ALH-L1005 600 mg

ALH-L1005 1,200 mg

Arm Description

Placebo twice a day

ALH-L1005 300 mg twice a day

ALH-L1005 600 mg twice a day

Outcomes

Primary Outcome Measures

Change in Pocket Depth(PD)

Change in Pocket Depth in Subjects

Secondary Outcome Measures

Change in Pocket Depth(PD)

Change in Pocket Depth in Subjects

Change in Clinical Attachment Level(CAL)

Change in Clinical Attachment Level in Subjects

Change in Gingival recession(GR)

Change in Gingival recession in Subjects

Change in Bleeding on probing(BOP) score

Change in Bleeding on probing score in Subjects

Full Information

NCT ID

NCT04503746

First Posted

August 5, 2020

Last Updated

August 9, 2022

Sponsor

AngioLab, Inc.

1. Study Identification

Unique Protocol Identification Number

NCT04503746

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Completed

Study Start Date

July 16, 2020 (Actual)

Primary Completion Date

December 13, 2021 (Actual)

Study Completion Date

December 13, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

AngioLab, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Chronic Periodontitis

Keywords

periodontitis

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

117 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo twice a day

Arm Title

ALH-L1005 600 mg

Arm Type

Experimental

Arm Description

ALH-L1005 300 mg twice a day

Arm Title

ALH-L1005 1,200 mg

Arm Type

Experimental

Arm Description

ALH-L1005 600 mg twice a day

Intervention Type

Drug

Intervention Name(s)

ALH-L1005 600mg/day

Intervention Description

ALH-L1005 300mg 2 tablet and placebo 2 tablet

Intervention Type

Drug

Intervention Name(s)

ALH-L1005 1,200mg/day

Intervention Description

ALH-L1005 300mg 4 tablet

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo 4 tablet

Primary Outcome Measure Information:

Title

Change in Pocket Depth(PD)

Description

Change in Pocket Depth in Subjects

Time Frame

baseline, 12 weeks

Secondary Outcome Measure Information:

Title

Change in Pocket Depth(PD)

Description

Change in Pocket Depth in Subjects

Time Frame

baseline, 4 weeks, 8 weeks

Title

Change in Clinical Attachment Level(CAL)

Description

Change in Clinical Attachment Level in Subjects

Time Frame

baseline, 4 weeks, 8 weeks, 12 weeks

Title

Change in Gingival recession(GR)

Description

Change in Gingival recession in Subjects

Time Frame

baseline, 12 weeks

Title

Change in Bleeding on probing(BOP) score

Description

Change in Bleeding on probing score in Subjects

Time Frame

baseline, 12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

78 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

AngioLab, Inc.

City

Daejeon

State/Province

Daejeon Gwangyeogsi

ZIP/Postal Code

34015

Country

Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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