Gingival InflammationPhase 1/2BLXA4NCT02342691
Safety and Preliminary Efficacy of Lipoxin Analog BLXA4-ME Oral Rinse for the Treatment of Gingivitis
A Phase 1/2 study testing BLXA4 in people with Gingival Inflammation, run by The Forsyth Institute at 1 site in United States.
Trial summary
The primary objective is to evaluate the safety of an investigational compound, BLXA4-ME, topically applied as a daily oral rinse in adults with gingivitis. Safety will be assessed by the incidence of adverse events, including mucosal inflammation and irritancy and findings from safety labs. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingival Inflammation
- What is being tested?
- BLXA4
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 127 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2015to 30 Aug 2019
- Phase
- Phase 1/2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Signed consent form
- Good general health as evidenced by medical history
- Age 18 - 65
- Must have a stable address and be available for the duration of the study
- Must have a minimum of 20 natural teeth, excluding third molars
- Must have a mean full mouth MGI of at least 2.0
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- Must be willing to use prescribed oral hygiene procedures and products
- Medications for chronic conditions must be stable for at least 3 months prior to enrollment
- Women of reproductive potential must use licensed hormonal contraception or double barrier methods
- Men of reproductive potential must agree to use condoms
- Liver function test (aspartate aminotransferase [AST], alanine aminotransferase [ALT], alkaline phosphatase, and total bilirubin) levels equal to or less than 1.5 times the upper limit of normal
- Serum creatinine levels equal to or less than the upper limit of normal;
- Subjects with complete blood count levels within 10% of the normal laboratory range and erythrocyte sedimentation rate equal to or less than 2 times the upper limit of normal.
Who cannot join
- Presence of orthodontic appliances or removable partial dentures
- Presence of a soft tissue tumor of the oral cavity
- Presence of gross plaque or calculus (≥ 75% of tooth surfaces)
- Presence of extensive restorations that could affect the marginal gingiva (at the investigators' discretion)
- Preexisting oral pathology, including carious lesions requiring immediate treatment or ulcerations of the mucosa
- Current participation in another clinical trial or product test
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- Pregnant or breast feeding
- Residence in the same household as a subject currently enrolled in the study (due to potential blinding and compliance issues)
- Concomitant endodontic therapy or periodontal therapy other than prophylaxis within the past 6 months
- History of early onset periodontitis or acute necrotizing ulcerative gingivitis
- Chronic disease with concomitant oral manifestations, such as autoimmune or immunosuppressive diseases (e.g., human immunodeficiency virus, severe combined immunodeficiency, neutropenia, juvenile arthritis, systemic lupus erythematosus, sickle cell anemia, Crohn's disease, rheumatoid arthritis, Sjögren's syndrome) or immunocompromised status due to cancer chemotherapy, hematopoietic stem cell or solid organ transplant, head and neck radiotherapy, splenectomy, chronic steroid usage
- Recent history of chronic alcohol consumption of more than five 1.5-ounce servings of 80 proof distilled spirits, five 12-ounce servings of beer, or five 5 ounce servings of wine per day
- Tobacco use (former tobacco users may be enrolled, provided they have been tobacco-free for one year or more)
- Diabetes mellitus
- Subjects with urinalysis results suggestive of infection (if a subject meets this criterion, he/she may be rescreened for study participation when he/she no longer meets this exclusion criterion)
- Medical conditions that the investigator considers significant and that may interfere with the examination or the safety of the subject
- Chronic use (2 weeks or more) of medication known to affect periodontal status within one month of enrollment (such as ≥81mg aspirin, phenytoin, calcium antagonists such as nifedipine, NSAIDs, coumarin, cyclosporine, ≥10 mg/day atorvastatin or equivalent dose of another statin [Subramanian et al, 2013]);
- Treatment with antibiotics within one month prior to enrollment
- Medical condition for which antibiotic treatment during the study period is likely or a condition for which antibiotic prophylaxis is recommended before dental procedures (American Heart Association guidelines of 2007 will be followed)
- Known hypersensitivity to any component of the test or placebo products
- Anything that, in the opinion of the investigator, would place the subject at increased risk or prevent the subject from fully complying with or completing the study -
Trial locations and contacts
1 site in 1 country.
United States1 site
The Forsyth Institute
Cambridge, Massachusetts, 02142
About this study
Official title: A Phase 1 / 2 Clinical Trial to Assess the Safety and Preliminary Efficacy of Lipoxin Analog BLXA4-ME Oral Rinse for the Treatment of Gingivitis
The primary objective is to evaluate the safety of an investigational compound, BLXA4-ME, topically applied as a daily oral rinse in adults with gingivitis. Safety will be assessed by the incidence of adverse events, including mucosal inflammation and irritancy and findings from safety labs. Subjects will be monitored for development of periodontitis, and oral flora will be analyzed to detect an increase in opportunistic organisms.
The secondary objective is to assess preliminary efficacy of the oral rinse, by monitoring changes in the plaque index (PI), modified gingival index (MGI), bleeding on probing (BOP) and levels of interleukin -1β (IL-1β) in gingival crevicular fluid (GCF).
The study comprises three groups in a randomized, placebo-controlled double-blind clinical trial design. The treatment group (1.0 μM BLXA4-ME oral rinse) and the placebo rinse group will each include 50 subjects. The no-rinse control group will consist of 25 subjects. Subjects in the treatment and placebo rinse groups will receive oral rinse (BLXA4-ME or placebo) to be applied once daily after morning teeth brushing. Safety parameters will be assessed before and after 3, 7, 14, 21, and 28 days of treatment. Efficacy parameters will be assessed before and after 14 and 28 days of treatment.
- Conditions
- Gingival Inflammation
- Being tested
- BLXA4, Placebo oral rinse
- Keywords
- Safety and efficacy of BLXA4
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BLXA4Drug
BLXA4-ME is a member of a new class of chemically and metabolically stable lipoxin analogs featuring a replacement of the tetraene unit of native lipoxin-A4 (LXA4) with a substituted benzo-fused ring system. The full chemical name of the BLXA4-ME drug substance is (5S, 6R, E)-methyl 5,6-dihydroxy-8-(2-((R,E)-3-hydroxyoct-1-enyl) phenyl) oct-7-enoate.
Placebo oral rinseDrug
The placebo preparation will consist of formulated oral rinse without BLXA4-ME and will be identical to the test rinse in color, appearance and taste
| Study group | Role | What they receive |
|---|---|---|
| BLXA4-ME oral rinse | Experimental | The topical oral rinse dosage form of BLXA4-ME (also known as ClinRinse-1) will consist of drug substance prepared at a concentration of 1.0 μM in an aqueous vehicle solution Receives: Drug: BLXA4 |
| Placebo oral rinse | Placebo comparator | The placebo preparation will consist of formulated oral rinse without BLXA4-ME and will be identical to the test rinse in color, appearance and taste Receives: Drug: Placebo oral rinse |
| No Rinse Control | No intervention | The no-rinse control group will use no oral rinse, in order to assess the effect of the rinsing action independent of the active ingredients |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Adverse Events
Adverse events will be recorded throughout the study, and may include events reported by subjects or changes observed in oral cavity examinations or vital signs (assessed at baseline, Days 3, 7, 14, 21 and 28). Blood and urine will be collected for safety labs at Days 14 and 28 after product administration, and subjects will undergo close monitoring for mucosal inflammation and irritancy and development of periodontitis, using standard clinical periodontal measurements. Follow-up will also occur at 90 days to assess for adverse events.
Measured: up to 90 days
Secondary outcomes (3)
Change in Mean MGI (Baseline and 28 Days)
MGI is a visual index used to score gingival inflammation on a scale of 0-4. Higher scores indicate increasing levels of gingival inflammation (worse outcome).
Measured: 28 days
Change in Percent Bleeding on Probing (Baseline and 28 Days)
Gingival Bleeding was assessed using the dichotomous bleeding on probing index
Bleeding on probing is reported as the percentage of tooth-sites that bleed on probing within a subject and higher BOP values indicate greater gingival inflammation.
Measured: 28 days
Change in PI (Baseline and 28 Days)
Plaque index (PI) is a visual index used to score (ranging from 0 to 5). A higher score is indicative of higher plaque build-up (worse outcome).
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2015 (estimated)
- Study startApr 2015
- Primary completion28 Sep 2017
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Gingival InflammationStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 127 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Forsyth Institute
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02342691
- Sponsor's protocol ID
- 16-085-E
- Other IDs
- U01DE026934-01
- Acronym
- BLXA4
- Status last verified
- Nov 2023
- First submitted
- 15 Jan 2015
- Last updated
- 20 Dec 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Publications
Hasturk H, Schulte F, Martins M, Sherzai H, Floros C, Cugini M, Chiu CJ, Hardt M, Van Dyke T. Safety and Preliminary Efficacy of a Novel Host-Modulatory Therapy for Reducing Gingival Inflammation. Front Immunol. 2021 Sep 13;12:704163. doi: 10.3389/fimmu.2021.704163. eCollection 2021.
PubMed 34589083
Study at a glance
From the registry record, last updated by the sponsor on 20 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 / 2 Clinical Trial to Assess the Safety and Preliminary Efficacy of Lipoxin Analog BLXA4-ME Oral Rinse for the Treatment of Gingivitis
- ClinicalTrials.gov ID
- NCT02342691
- Acronym / sponsor ID
- BLXA4 / 16-085-E
- Conditions
- Gingival Inflammation
- Keywords
- Safety and efficacy of BLXA4
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 127 participants (actual)
- Lead sponsor
- The Forsyth InstituteUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- Apr 2015
- Primary completion
- 28 Sep 2017 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 21 Jan 2015 (estimated)
- Results
- Posted 20 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to evaluate the safety of an investigational compound, BLXA4-ME, topically applied as a daily oral rinse in adults with gingivitis. Safety will be assessed by the incidence of adverse events, including mucosal inflammation and irritancy and findings from safety labs. Subjects will be monitored for development of periodontitis, and oral flora will be analyzed to detect an increase in opportunistic organisms.
The secondary objective is to assess preliminary efficacy of the oral rinse, by monitoring changes in the plaque index (PI), modified gingival index (MGI), bleeding on probing (BOP) and levels of interleukin -1β (IL-1β) in gingival crevicular fluid (GCF).
The study comprises three groups in a randomized, placebo-controlled double-blind clinical trial design. The treatment group (1.0 μM BLXA4-ME oral rinse) and the placebo rinse group will each include 50 subjects. The no-rinse control group will consist of 25 subjects. Subjects in the treatment and placebo rinse groups will receive oral rinse (BLXA4-ME or placebo) to be applied once daily after morning teeth brushing. Safety parameters will be assessed before and after 3, 7, 14, 21, and 28 days of treatment. Efficacy parameters will be assessed before and after 14 and 28 days of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| BLXA4-ME oral rinse | Experimental | Drug: BLXA4The topical oral rinse dosage form of BLXA4-ME (also known as ClinRinse-1) will consist of drug substance prepared at a concentration of 1.0 μM in an aqueous vehicle solution |
| Placebo oral rinse | Placebo comparator | Drug: Placebo oral rinseThe placebo preparation will consist of formulated oral rinse without BLXA4-ME and will be identical to the test rinse in color, appearance and taste |
| No Rinse Control | No intervention | –The no-rinse control group will use no oral rinse, in order to assess the effect of the rinsing action independent of the active ingredients |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (13 listed)
- Signed consent form
- Good general health as evidenced by medical history
- Age 18 - 65
- Must have a stable address and be available for the duration of the study
- Must have a minimum of 20 natural teeth, excluding third molars
Key exclusion criteria (21 listed)
- Presence of orthodontic appliances or removable partial dentures
- Presence of a soft tissue tumor of the oral cavity
- Presence of gross plaque or calculus (≥ 75% of tooth surfaces)
- Presence of extensive restorations that could affect the marginal gingiva (at the investigators' discretion)
- Preexisting oral pathology, including carious lesions requiring immediate treatment or ulcerations of the mucosa
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 |
|---|---|---|
| BLXA4BLXA4-ME is a member of a new class of chemically and metabolically stable lipoxin analogs featuring a replacement of the tetraene unit of native lipoxin-A4 (LXA4) with a substituted benzo-fused ring system. The full chemical name of the BLXA4-ME drug substance is (5S, 6R, E)-methyl 5,6-dihydroxy-8-(2-((R,E)-3-hydroxyoct-1-enyl) phenyl) oct-7-enoate. | Drug | BLXA4-ME oral rinse |
| Placebo oral rinseThe placebo preparation will consist of formulated oral rinse without BLXA4-ME and will be identical to the test rinse in color, appearance and taste | Drug | Placebo oral rinse |
Primary outcome
Incidence of Adverse Events
Time frame: up to 90 days
Adverse events will be recorded throughout the study, and may include events reported by subjects or changes observed in oral cavity examinations or vital signs (assessed at baseline, Days 3, 7, 14, 21 and 28). Blood and urine will be collected for safety labs at Days 14 and 28 after product administration, and subjects will undergo close monitoring for mucosal inflammation and irritancy and development of periodontitis, using standard clinical periodontal measurements. Follow-up will also occur at 90 days to assess for adverse events.
3 secondary outcomes
Change in Mean MGI (Baseline and 28 Days)
Time frame: 28 days
Change in Percent Bleeding on Probing (Baseline and 28 Days)
Time frame: 28 days
Change in PI (Baseline and 28 Days)
Time frame: 28 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Dec 2023.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34589083Hasturk H, Schulte F, Martins M, Sherzai H, Floros C, Cugini M, Chiu CJ, Hardt M, Van Dyke T. Safety and Preliminary Efficacy of a Novel Host-Modulatory Therapy for Reducing Gingival Inflammation. Front Immunol. 2021 Sep 13;12:704163. doi: 10.3389/fimmu.2021.704163. eCollection 2021.
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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 1/2 study testing BLXA4 in people with Gingival Inflammation, run by The Forsyth Institute at 1 site in United States.
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 13 inclusion and 21 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 20 Dec 2023. 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 United States. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Yes. Results are posted in the registry (first posted 20 Dec 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Incidence of Adverse Events (time frame: up to 90 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02342691, which also lists 1 linked publication.
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 20 Dec 2023.