Safety and Preliminary Efficacy of Lipoxin Analog BLXA4-ME Oral Rinse for the Treatment of Gingivitis

PHASE1/PHASE2CompletedINTERVENTIONAL
Enrollment

127

Participants

Timeline

Start Date

April 30, 2015

Primary Completion Date

September 28, 2017

Study Completion Date

August 30, 2019

Conditions
Gingival Inflammation
Interventions
DRUG

BLXA4

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.

DRUG

Placebo oral rinse

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

Trial Locations (1)

02142

The Forsyth Institute, Cambridge

All Listed Sponsors
collaborator

National Institute of Dental and Craniofacial Research (NIDCR)

NIH

lead

The Forsyth Institute

OTHER

NCT02342691 - Safety and Preliminary Efficacy of Lipoxin Analog BLXA4-ME Oral Rinse for the Treatment of Gingivitis | Biotech Hunter | Biotech Hunter