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NCT02342691 · ClinicalTrials.gov registry record · Phase 1
Safety and Preliminary Efficacy of Lipoxin Analog BLXA4-ME Oral Rinse for the Treatment of Gingivitis
A Phase 1 study of Gingival Inflammation, sponsored by The Forsyth Institute.
- Completed
- Registry status
- Phase 1
- Development phase
- 127
- Enrollment target
- 1
- Study location
NCT02342691: Completed Phase 1 study of Gingival Inflammation, sponsored by The Forsyth Institute.
NCT02342691 is a Phase 1 study of Gingival Inflammation that has completed, run by The Forsyth Institute. The registered enrollment target is 127 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (112% higher). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02342691, a Phase 1 study of Gingival Inflammation, has completed, sponsored by The Forsyth Institute.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 127 participants
- Enrollment target
- 1
- Study location
Study 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. 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.
Primary Outcome
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
Conditions Studied
Interventions
- DRUG BLXA4
- DRUG Placebo oral rinse
Study Locations (1)
Massachusetts
- The Forsyth Institute - Cambridge
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 127 participants |
| Start Date | 2015-04 |
| Est. Completion | 2019-08-30 |
| Phase | Phase 1 |
What the finished NCT02342691 record still lists
NCT02342691 is an interventional study that assigns participants to a tested intervention. The registered 127 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (112% higher).
The record links to 1 condition, with Gingival Inflammation appearing as the primary indexed condition, and to 2 interventions - of which BLXA4 is the first listed.
NCT02342691 reports a single indexed study location in Massachusetts.
Frequently Asked Questions
What is clinical trial NCT02342691 about?
NCT02342691 is a clinical study titled "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. Subject...
What is the current status of trial NCT02342691?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 127 participants. The study started on 2015-04. Estimated completion is 2019-08-30.
What conditions does trial NCT02342691 study?
This clinical trial studies the following conditions: Gingival Inflammation.
What interventions are being tested in trial NCT02342691?
The interventions under investigation include: BLXA4 (DRUG), Placebo oral rinse (DRUG).
Who is sponsoring clinical trial NCT02342691?
This trial is sponsored by The Forsyth Institute, which has 6 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02342691 being conducted?
This trial has 1 study location across Massachusetts. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT02342691's enrollment target sits among peer trials
127 459th of 2000 higher than 1,540 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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