Phase 1/2 Clinical Trial to assess the safety and preliminary efficacy of Lipoxin Analog BLXA4-MEOral Rinse for the Treatment of Gingivitis

项目摘要 此应用程序寻求资金以完成正在进行的1/2期临床试验，以评估 脂氧素类似物BLXA4-ME口服液治疗慢性阻塞性肺疾病的安全性和初步疗效 牙周炎。这项研究包括3组随机、安慰剂对照、双盲临床试验 试验设计，设治疗组、安慰剂含漱组和非含漱组。这个 治疗组(1μM BLXA4-ME口腔含漱剂)和安慰剂含漱组各50例。 不冲洗对照组为25例。治疗中的受试者和安慰剂含漱剂 每天早晨拔牙后使用口腔漱口水(BLXA4-ME或安慰剂)。 刷牙。安全参数将在治疗前和治疗前3、7、14、21和28天评估 经过初步治疗后。疗效参数将在治疗前、14天和28天进行评估 经过初步治疗后。主要目标是评估一项调查的安全性 BLXA4-ME化合物，用于患有牙周炎的成年人的日常口腔冲洗。 安全性评估将包括不良事件的发生率，包括粘膜炎症。 和刺激性，以及安全实验室测试的结果。受试者将被监测 将对牙周炎和口腔菌群的发展或进展进行分析，以检测出 机会主义有机体。次要目标是评估口服的初步疗效。 通过监测菌斑指数(PI)、改良牙龈指数(MGI)、出血量的变化进行冲洗 探诊敏感度、龈沟液中白细胞介素1β(IL-1β)水平及 治疗前后血清中特殊脂类介体的变化。主动者 制剂(试液)将含有1.0μM的BLXA4-ME，配方含漱液含10% 乙醇和0.25%十二烷基硫酸钠。化合物BLXA4-ME是脂氧素A4的类似物， 由必需脂肪酸花生四烯酸生物合成的局部作用的脂质介体。在……里面 BLXA4-ME，一个稠合的邻位取代苯并环被结合在四烯的两个位置之间 天然脂氧素A4的单位。安慰剂制剂将由配方口腔漱口水组成，不含 BLXA4ME。每个受试者的参与时间约为3个月(通过访问 28天外加最后一次使用产品后2个月的安全跟踪电话)。招聘率为 每月大约20名受试者，其中6-8人是随机的。根据这一比率，它是 预计招生工作将在12个月内完成。

Project Summary This application seeks funding to complete an ongoing 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 study comprises 3 groups in a randomized, placebo-controlled, double-blind clinical trial design, a treatment group, the placebo rinse group and the no-rinse control group. The treatment group (1.0 μM BLXA4-ME oral rinse) and the placebo rinse group include 50 subjects. The no-rinse control group consists of 25 subjects. Subjects in the treatment and placebo rinse groups receive oral rinse (BLXA4-ME or placebo) to be used once daily after morning teeth brushing. Safety parameters will be assessed before treatment and 3, 7, 14, 21, and 28 days after initial treatment. Efficacy parameters will be assessed before treatment and 14 and 28 days after initial treatment. The primary objective is to evaluate the safety of an investigational compound, BLXA4-ME, topically applied as a daily oral rinse in adults with gingival inflammation. Safety assessments will include the incidence of adverse events, including mucosal inflammation and irritancy, and findings from safety laboratory tests. Subjects will be monitored for development or progression 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) sensitivity, levels of interleukin-1β (IL-1β) in gingival crevicular fluid (GCF) and changes in the specialized lipid mediator profile in serum before and after treatment. The active preparation (test rinse) will contain BLXA4-ME at 1.0 μM in a formulated oral rinse containing 10% ethanol and 0.25% sodium lauryl sulfate. The compound BLXA4-ME is an analog of lipoxin A4, a locally acting lipid mediator biosynthesized from the essential fatty acid, arachidonic acid. In BLXA4-ME, a fused o-substituted benzo-ring is incorporated between 2 positions of the tetraene unit of native lipoxin A4. The placebo preparation will consist of formulated oral rinse without BLXA4ME. The duration of participation of each subject is approximately 3 months (visits through 28 days plus safety follow-up phone call 2 months after last product use). The recruitment rate is approximately 20 subjects per month of which 6-8 are randomized. Based upon this rate, it is estimated that enrollment will be completed in 12 months.