A Multi-Center, Double-Blind, Vehicle Controlled, Phase II Study of JNJ 10229570-AAA for the Treatment of Acne Vulgaris
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 431
- 试验地点
- 17
- 主要终点
- Change in Total Acne Lesion Counts
研究概览
简要总结
A study to determine if three different doses of a new acne treatment are safe and better at reducing facial acne than a treatment without active ingredient.
详细描述
Approximately 400 male and female subjects with moderate facial acne vulgaris will be enrolled in this randomized, multi-center study. Following satisfaction of entry criteria and screening procedures, subjects will be randomized to either 1.2%, 2.4%, or 3.6% facial cream (JNJ 10229570-AAA) or color-matched vehicle. Subjects will apply the study medication once daily on the face for 12 weeks. Safety will be monitored throughout the study duration. Efficacy will be assessed by facial lesion counts and by the investigator global evaluation of acne severity at Baseline and at Weeks 2, 4, 6, 8, 10, and 12. Approximately 50 subjects from one investigational site also will have serums collected at Weeks 6 and 12 for evaluation of the multiple dose pharmacokinetics of JNJ 10229570-AAA cream.
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, Investigator)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •12 years of age or older, with moderate facial acne vulgaris as defined in the protocol
- •If female of childbearing potential, must take a pregnancy test and have a negative result
- •Females of childbearing potential must also agree to use an adequate method of birth control, which would include:
- •systemic birth control (Subjects must have been taking the same type of birth control for at least 3 months prior to entering the study and must not change type of birth control during the study)
- •Condom with spermicide
- •IUD. Females who have had a hysterectomy, bilateral oophorectomy or bilateral tubal ligation are not required to use additional birth control methods
排除标准
- •Known sensitivity to any of the ingredients in the study medication
- •More than 3 nodulocystic acne lesions
- •Use of acne treatments, therapies or medications within protocol-specified timeframes
- •Presence of other skin conditions, diseases, or medical conditions that (per protocol or in the opinion of the investigator) may require concurrent therapy, interfere with the evaluation of the study medication, or compromise subject safety
- •Excessive facial hair that may interfere with application of the medication and/or evaluations
研究组 & 干预措施
1.2% Facial Cream
1.2% JNJ 10229570-AAA
干预措施: 1.2% JNJ 10229570-AAA (Drug)
2.4% Facial Cream
2.4% JNJ 10229570-AAA
干预措施: 2.4% JNJ 10229570-AAA (Drug)
3.6% Facial Cream
3.6% JNJ 10229570-AAA
干预措施: 3.6% JNJ 10229570-AAA (Drug)
0% Facial Cream
Vehicle control
干预措施: Vehicle control (Other)
结局指标
主要结局
Change in Total Acne Lesion Counts
时间窗: Baseline to Week 12
Change in lesion counts between baseline and end of study
次要结局
- Change From Baseline in the Inflammatory Acne Lesion Counts(Baseline through Week 12)
- Percent Change From Baseline in the Non-Inflammatory Acne Lesion Counts(Baseline through Week 12)
- Percent Change From Baseline in the Inflammatory Acne Lesion Counts(Baseline through Week 12)
- Change From Baseline in the Non-inflammatory Acne Lesion Counts(Baseline through Week 12)
- Percent Change From Baseline in Total Acne Lesion Counts(Baseline through Week 12.)