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

• Sponsor: AngioLab, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04503746
• Collaborator: (none)
• Enrollment: 117
• Location: 1
• Arms: 3
• Actual Duration (Months): 16.9
• Patients Per Site Per Month: 6.9

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Chronic Periodontitis	Drug: ALH-L1005 600mg/day; Drug: ALH-L1005 1,200mg/day; Drug: Placebo	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 117 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Jul 16, 2020
• Actual Primary Completion Date: Dec 13, 2021
• Actual Study Completion Date: Dec 13, 2021

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Change in Pocket Depth(PD) [baseline, 12 weeks]

   Change in Pocket Depth in Subjects

Secondary Outcome Measures

1. Change in Pocket Depth(PD) [baseline, 4 weeks, 8 weeks]

   Change in Pocket Depth in Subjects

2. Change in Clinical Attachment Level(CAL) [baseline, 4 weeks, 8 weeks, 12 weeks]

   Change in Clinical Attachment Level in Subjects

3. Change in Gingival recession(GR) [baseline, 12 weeks]

   Change in Gingival recession in Subjects

4. Change in Bleeding on probing(BOP) score [baseline, 12 weeks]

   Change in Bleeding on probing score in Subjects

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 78 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AngioLab, Inc.	Daejeon	Daejeon Gwangyeogsi	Korea, Republic of	34015

Sponsors and Collaborators

• AngioLab, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: AngioLab, Inc.
• ClinicalTrials.gov Identifier: NCT04503746
• Other Study ID Numbers: AL102-PDT
• First Posted: Aug 7, 2020
• Last Update Posted: Aug 11, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by AngioLab, Inc.: periodontitis
• Additional relevant MeSH terms: Periodontitis; Chronic Periodontitis

Study Results

No Results Posted as of Aug 11, 2022