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
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 127
- 试验地点
- 1
- 主要终点
- Incidence of Adverse Events
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
- •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.
排除标准
- •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
- •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 -
研究组 & 干预措施
BLXA4-ME oral rinse
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
干预措施: BLXA4 (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
干预措施: Placebo oral rinse (Drug)
结局指标
主要结局
Incidence of Adverse Events
时间窗: 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.
次要结局
- Change in PI (Baseline and 28 Days)(28 days)
- Change in Percent Bleeding on Probing (Baseline and 28 Days)(28 days)
- Change in Mean MGI (Baseline and 28 Days)(28 days)