A PHASE 1, SINGLE-CENTER, RANDOMIZED, VEHICLE AND WHITE PETROLATUM CONTROLLED, EVALUATOR BLINDED STUDY TO ASSESS THE SKIN IRRITATION POTENTIAL WITH A RANGE OF CONCENTRATIONS OF PF-06700841 CREAM IN ADULT JAPANESE HEALTHY PARTICIPANTS
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- The proportion of participants who have skin irritation grade equal to or greater than two plus (++) up to Day 4
研究概览
简要总结
This is a Phase 1, single center, randomized, vehicle and white petrolatum controlled, evaluator blinded study to assess the skin irritation potential with a range of concentrations of PF-06700841 cream including vehicle and empty patch with white petrolatum under occlusive conditions in adult Japanese healthy participants.
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
- Double (Participant, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male and female participants must be 20 to 55 years of age, inclusive, at the time of signing the informed consent document.
- •Body mass index (BMI) of 17.5 to 25 kg/m2; and a total body weight >50 kg (110 lb).
排除标准
- •Evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurological, or allergic disease.
- •Participants who have any visible skin condition at the application site which, in the opinion of the investigative personnel, will interfere with the evaluation of the test site reaction.
- •Participants who have psoriasis and/or active AD/eczema/urticaria.
- •Participants who have a history of AD.
- •Participants who have damaged skin in or around the test sites, including sunburn, excessively deep tans, uneven skin tones, tattoos, scars, excessive hair, numerous freckles, or other disfigurations of the test site.
- •History of known or suspected intolerance to any of the ingredients of the investigational products, adhesive tape/plaster, or the test patches.
研究组 & 干预措施
PF-06700841 cream 0%
All participants will have 6 application sites where 6 patches of investigational products will be completely randomly assigned, for the purpose of determining irritation potential
干预措施: PF-06700841 cream (Drug)
PF-06700841 cream 0.1%
All participants will have 6 application sites where 6 patches of investigational products will be completely randomly assigned, for the purpose of determining irritation potential
干预措施: PF-06700841 cream (Drug)
PF-06700841 cream 0.3%
All participants will have 6 application sites where 6 patches of investigational products will be completely randomly assigned, for the purpose of determining irritation potential
干预措施: PF-06700841 cream (Drug)
PF-06700841 cream 1%
All participants will have 6 application sites where 6 patches of investigational products will be completely randomly assigned, for the purpose of determining irritation potential
干预措施: PF-06700841 cream (Drug)
PF-06700841 cream 3%
All participants will have 6 application sites where 6 patches of investigational products will be completely randomly assigned, for the purpose of determining irritation potential
干预措施: PF-06700841 cream (Drug)
White petrolatum
All participants will have 6 application sites where 6 patches of investigational products will be completely randomly assigned, for the purpose of determining irritation potential
干预措施: White petrolatum (Drug)
结局指标
主要结局
The proportion of participants who have skin irritation grade equal to or greater than two plus (++) up to Day 4
时间窗: Up to Day 4
Skin irritation grade is defined as following: no reaction (-); slight erythema (+-); erythema (+); erythema + edema, papules (++); erythema + edema + papules + vesicles (small blisters) (+++) ; large blisters (++++)
次要结局
- The number of each skin irritation score reported by treatment on each assessment day(Day 3 and Day 4)
- The proportion of participants who have skin irritation grade equal to or greater than two plus (++) on each assessment day (Day 3 and Day 4)(Day 3 and Day 4)
- The number of the maximum skin irritation score reported up to Day 4 by treatment(Up to Day 4)
- The percentage of the maximum skin irritation score reported up to Day 4 by treatment(Up to Day 4)
- The percentage of each skin irritation score reported by treatment on each assessment day(Day 3 and Day 4)
- Number of Participants Discontinuation Due to AEs(Baseline up to Day 35)
- Number of Treatment-Emergent Adverse Events (AEs) or Serious Adverse Events (SAEs)(Baseline up to Day 35)