Chronic PeriodontitisPhase 2NCT04503746
A Study to Evaluate the Efficacy and Safety of ALH-L1005 in Patients With Chronic Periodontitis
A Phase 2 study testing ALH-L1005 600mg/day and ALH-L1005 1,200mg/day in people with Chronic Periodontitis, run by AngioLab, Inc. at 1 site in South Korea.
Trial summary
The main objective of this study is to evaluate efficacy and safety of ALH-L1005 in patients with chronic periodontitis Read more about this study
- Who is it for?
- Ages 18 to 78 years
- Conditions the study is for
- Chronic Periodontitis
- What is being tested?
- ALH-L1005 600mg/day and ALH-L1005 1,200mg/day
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 117 participants
- Where
- 1 siteSouth Korea
- Study dates
- 16 Jul 2020to 13 Dec 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 78 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
The main objective of this study is to evaluate efficacy and safety of ALH-L1005 in patients with chronic periodontitis
- Conditions
- Chronic Periodontitis
- Being tested
- ALH-L1005 600mg/day, ALH-L1005 1,200mg/day, Placebo
- Keywords
- periodontitis
- Medical subject headings
- Chronic Periodontitis, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ALH-L1005 600mg/dayDrug
ALH-L1005 300mg 2 tablet and placebo 2 tablet
ALH-L1005 1,200mg/dayDrug
ALH-L1005 300mg 4 tablet
PlaceboDrug
Placebo 4 tablet
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo twice a day Receives: Drug: Placebo |
| ALH-L1005 600 mg | Experimental | ALH-L1005 300 mg twice a day Receives: Drug: ALH-L1005 600mg/day |
| ALH-L1005 1,200 mg | Experimental | ALH-L1005 600 mg twice a day Receives: Drug: ALH-L1005 1,200mg/day |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Pocket Depth(PD)
Change in Pocket Depth in Subjects
Measured: baseline, 12 weeks
Secondary outcomes (4)
Change in Pocket Depth(PD)
Change in Pocket Depth in Subjects
Measured: baseline, 4 weeks, 8 weeks
Change in Clinical Attachment Level(CAL)
Change in Clinical Attachment Level in Subjects
Measured: baseline, 4 weeks, 8 weeks, 12 weeks
Change in Gingival recession(GR)
Change in Gingival recession in Subjects
Measured: baseline, 12 weeks
Change in Bleeding on probing(BOP) score
Change in Bleeding on probing score in Subjects
Measured: baseline, 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Aug 2020
- Study start16 Jul 2020
- Primary completion13 Dec 2021
- Study completion13 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 117 participants (actual)
Sponsor and investigators
- Lead sponsor
- AngioLab, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04503746
- Sponsor's protocol ID
- AL102-PDT
- Status last verified
- Aug 2022
- First submitted
- 5 Aug 2020
- Last updated
- 11 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT04503746
- Acronym / sponsor ID
- AL102-PDT
- Conditions
- Chronic Periodontitis
- Keywords
- periodontitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 117 participants (actual)
- Lead sponsor
- AngioLab, Inc.Industry (pharma, biotech, devices)
- Study start
- 16 Jul 2020 (actual)
- Primary completion
- 13 Dec 2021 (actual)
- Study completion
- 13 Dec 2021 (actual)
- First posted
- 7 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of this study is to evaluate efficacy and safety of ALH-L1005 in patients with chronic periodontitis
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo twice a day |
| ALH-L1005 600 mg | Experimental | Drug: ALH-L1005 600mg/dayALH-L1005 300 mg twice a day |
| ALH-L1005 1,200 mg | Experimental | Drug: ALH-L1005 1,200mg/dayALH-L1005 600 mg twice a day |
Who may qualify
- Ages
- 18 to 78 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ALH-L1005 600mg/dayALH-L1005 300mg 2 tablet and placebo 2 tablet | Drug | ALH-L1005 600 mg |
| ALH-L1005 1,200mg/dayALH-L1005 300mg 4 tablet | Drug | ALH-L1005 1,200 mg |
| PlaceboPlacebo 4 tablet | Drug | Placebo |
Primary outcome
Change in Pocket Depth(PD)
Time frame: baseline, 12 weeks
Change in Pocket Depth in Subjects
4 secondary outcomes
Change in Pocket Depth(PD)
Time frame: baseline, 4 weeks, 8 weeks
Change in Clinical Attachment Level(CAL)
Time frame: baseline, 4 weeks, 8 weeks, 12 weeks
Change in Gingival recession(GR)
Time frame: baseline, 12 weeks
Change in Bleeding on probing(BOP) score
Time frame: baseline, 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing ALH-L1005 600mg/day and ALH-L1005 1,200mg/day in people with Chronic Periodontitis, run by AngioLab, Inc. at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Pocket Depth(PD) (time frame: baseline, 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2022.