A Randomized, Double Blinded, Single Topical Dose Study of JNJ 10229570-AAA to Evaluate Safety and Tolerability in Japanese Subjects With Acne Vulgaris
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 18
- 主要终点
- Topical Dermatological Assessment (Scores on Scales)
研究概览
简要总结
The purpose of this study is to evaluate the safety and tolerability of JNJ 10229570-AAA after a single topical application of JNJ 10229570-AAA 1.2% and 3.6% cream in Japanese participants with acne.
详细描述
This is a randomized (drug assigned by chance like flipping a coin), double blinded (neither physician nor patient knows the name of the assigned drug), single dose ascending study of JNJ 10229570-AAA in Japanese participants with acne. The study will evaluate the safety and pharmacokinetics ([PK] how the drug is absorbed in the body, how it is distributed within the body and removed from the body over time) of M1 (active metabolite) in a total of eighteen (18) participants enrolled in the study, nine (9) in each group. Each participant will receive JNJ 10229570-AAA at 1.2%, 3.6% or vehicle in a cream formulation as a 2.5 mL application, to the face, neck, shoulders, chest and upper back areas. The investigational product will be washed off after the blood sampling at 24 hours after application. Safety and tolerability will be evaluated throughout the study and a topical dermatological assessment will be done by the dermatologists. The total duration of the study will be maximum 35 days.
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 35 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have Acne vulgaris, presenting at least inflammatory lesion on the face
- •Body mass index between 18.0 and 30.0 kg/m2 (inclusive), and body weight not less than 50 kg (man) or 45 kg (woman)
- •Blood pressure between 90 and 140 mmHg systolic (inclusive), and no higher than 90 mmHg diastolic
- •Electrocardiogram (ECG) consistent with normal cardiac conduction and function
- •Non-smoker
- •Adequate contraception method for both men and women. If a woman, must have a negative pregnancy test
- •Signed an informed consent document
排除标准
- •History of or current clinically significant medical illness that the investigator considers should exclude the participant or that could interfere with the interpretation of the study results
- •Clinically significant abnormal values for hematology, biochemistry or urinalysis
- •Clinically significant abnormal physical examination, vital signs or ECG - Use of any prescription or nonprescription medication within 14 days before the study treatment
- •History of drug or alcohol abuse within the past 5 years
- •Drug allergy or drug hypersensitivity
- •Blood donation, depending on the volume of blood collection
- •Positive test for human immunodeficiency virus (HIV), hepatitis B or C, or syphilis
- •Dermatological disease at application site
- •Photosensitivity
- •Exposure to excessive or chronic ultraviolet (UV) radiation (i.e., sunbathing, tanning salon use, phototherapy) within 4 weeks prior to study treatment or planned during the study period
研究组 & 干预措施
JNJ 10229570-AAA 1.2%
干预措施: JNJ 10229570-AAA 1.2% (Drug)
JNJ 10229570-AAA 1.2%
干预措施: Color-matched vehicle containing 0 mg of JNJ 10229570-AAA (Drug)
JNJ 10229570-AAA 3.6%
干预措施: JNJ 10229570-AAA 3.6% (Drug)
JNJ 10229570-AAA 3.6%
干预措施: Color-matched vehicle containing 0 mg of JNJ 10229570-AAA (Drug)
结局指标
主要结局
Topical Dermatological Assessment (Scores on Scales)
时间窗: Days 1-7
The Topical Dermatological Assessment is based on the 3 to 4-point Cutaneous Irritation Grading Scales that assess the level of Erythema, Dryness, Peeling/Scaling, Burning/Stinging, and Itching from 0 (no reaction) to 3 or 4 (strong reaction). In addition, the assessment observes and records any pigmentation change that may occur on the skin after the intervention.
次要结局
- Plasma M1 concentrations(12 time points up to 72 hours)
- PK parameters(12 time points up to 72 hours)