Safety, Tolerability and Pharmacokinetics of AGN-190168 in Subjects With Acne Vulgaris
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- Allergan
- 入组人数
- 78
- 主要终点
- Maximum Plasma Level (Cmax) of AGN-190168 Metabolite
研究概览
简要总结
This is a safety, tolerability and pharmacokinetics study of AGN-190168 in subjects with acne vulgaris.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- Single (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
- •Diagnosis of acne vulgaris on the face
- •No tobacco use for the past 30 days, and willing to refrain from nicotine use during the study
- •Willing to avoid excessive or prolonged exposure of the treated skin to ultraviolet light (eg, sunlight, tanning beds) and extremes in weather, such as wind or cold, throughout the study
- •If male, willing to maintain routine shaving regimen for the duration of the study and avoid shaving 12 hours prior to specified visits
- •Females of childbearing potential must use a reliable method of contraception
排除标准
- •Use of phototherapy devices (eg, ClearLight™) and adhesive cleansing strips (eg, Ponds® and Biore®), as well as cosmetic procedures (eg, facials, peeling, and comedone extraction) in the area to be treated in the past 1 week
- •Use of topical anti-inflammatory drugs, salicylic acid (eg, Clearasil® and Clean & Clear®), corticosteroids, antibiotics, antibacterials (including benzoyl peroxide-containing products [eg, benzamycin]), retinoids, and other topical acne treatments (eg, photodynamic therapy, laser therapy, and medicated soaps) in the area to be treated in the past 2 weeks
- •Ability to abstain from caffeine-containing products on the dates instructed
研究组 & 干预措施
AGN-190168 Formulation 1
AGN-190168 Formulation 1 applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.
干预措施: AGN-190168 Formulation 1 (Drug)
AGN-190168 Formulation 2
AGN-190168 Formulation 2 applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.
干预措施: AGN-190168 Formulation 2 (Drug)
TAZORAC® Gel 0.1%
TAZORAC® Gel 0.1% (tazarotene gel 0.1%) applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.
干预措施: tazarotene gel 0.1% (Drug)
TAZORAC® Cream 0.1%
TAZORAC® Cream 0.1% (tazarotene cream 0.1%) applied topically to the face, neck, upper chest, upper back, and shoulders once daily for 29 days.
干预措施: tazarotene cream 0.1% (Drug)
结局指标
主要结局
Maximum Plasma Level (Cmax) of AGN-190168 Metabolite
时间窗: Day 29
Local Dermal Tolerability as Assessed by the Investigator Using a 4-Point Scale
时间窗: Day 29
Maximum Plasma Level (Cmax) of AGN-190168
时间窗: Day 29
Local Dermal Tolerability as Assessed by the Subject Using a 4-Point Scale
时间窗: Day 29
次要结局
未报告次要终点