A Randomized, Controlled Study to Evaluate the Effect of Topically Applied BBI-2000 (5%) on Allergic Responses in Subjects With Contact Hypersensitivity to Diphencyprone
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 47
- 试验地点
- 1
- 主要终点
- Number of adverse events in each study group
研究概览
简要总结
This two cohort study (Cohort A and B) is being conducted to assess the safety and efficacy of BBI-2000 for the prevention (Cohort A) and treatment (Cohort B) of delayed type hypersensitivity reaction.
详细描述
This two cohort (Cohort A and B) single-center, randomized, controlled study is being conducted to evaluate the safety and efficacy of BBI-2000 for the prevention (Cohort A) and treatment (Cohort B) of delayed type hypersensitivity (DTH) reactions.
Subjects in Cohort A will initially receive either pre-treatment with BBI-2000 or vehicle, on an area on the back. Diphencyprone (DPCP) will then be administered, via Finn chamber, to the same area on the back. The treated area will then be assessed to determine if BBI-2000 was effective in preventing a contact hypersensitivity reaction.
Cohort B will first be sensitized with DPCP as in Cohort A. Indicated regions of the back will then be challenged to illicit a DTH reaction. Following the challenge, indicated regions on the subject's back will be treated with either (A) BBI-2000, (B) vehicle, (C) no topical application or (D) clobetasol propionate. The efficacy of BBI-2000 will be evaluated by monitoring response of the area of contact hypersensitivity reaction.
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
- Quadruple (Participant, Care Provider, 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
- •Individuals aged 18 to 65 years inclusive at the time of consent, and either female of non-reproductive potential or male.
- •Subjects must be healthy, normal volunteers per physical exam, laboratory and EKG assessments
排除标准
- •History of contact dermatitis to medical adhesive bandages or glue.
- •Medical history of dermatographism.
- •Any medical condition causing immunosuppression.
- •Prior treatment or therapies or history of sensitivity to any of the study products.
研究组 & 干预措施
BBI-2000
Cohort A
干预措施: BBI-2000 (Drug)
Vehicle
Cohort A
干预措施: Vehicle (Drug)
Multiple treatments
Cohort B
干预措施: BBI-2000 (Drug)
Multiple treatments
Cohort B
干预措施: Vehicle (Drug)
Multiple treatments
Cohort B
干预措施: Multiple treatments (Other)
结局指标
主要结局
Number of adverse events in each study group
时间窗: 4 weeks
Comparison of the number and severity of adverse event between study groups
Vital signs, physical examinations, ECG, blood analysis, urine analysis
时间窗: 4 weeks
Changes in vital signs, physical examinations, ECG, blood and urine analyses between study groups
Size of contact hypersensitivity reaction
时间窗: 4 weeks
Mean diameter (mm) of the contact hypersensitivity reaction induced by DPCP for subjects randomized to BBI-2000 (5%) as compared with vehicle
次要结局
- Dermal thickness(4 weeks)
- Diameter (mm) of the contact hypersensitivity area(4 weeks)