NCT03003247已完成2 期
A Phase 2, Multi-Center, Randomized, Double-Blind, Vehicle- Controlled, Parallel-Group, Clinical Study Comparing the Efficacy and Safety of IDP-120 Gel in the Treatment of Acne Vulgaris
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 364
- 试验地点
- 24
- 主要终点
- Percent of subjects achieving clear or almost clear on the Evaluator's Global Severity Score.
研究概览
简要总结
Efficacy and Safety of IDP-120 Gel in the Treatment of Acne Vulgaris
详细描述
A Phase 2, Multi-Center, Randomized, Double-Blind, Vehicle- Controlled, Parallel-Group, Clinical Study Comparing the Efficacy and Safety of IDP-120 Gel in the Treatment of 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
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 9 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female at least 9 years of age and older;
- •Written and verbal informed consent must be obtained. Subjects less than age of consent must sign an assent for the study and a parent or a legal guardian must sign the informed consent (if subject reaches age of consent during the study they should be re-consented at the next study visit)
- •Pre-menses females and women of childbearing potential must have a negative urine pregnancy test at screening visit, and a negative urine pregnancy test at baseline visit.
- •Subjects must be willing to comply with study instructions and return to the clinic for required visits. Subjects under the age of consent must be accompanied by the parent or legal guardian at the time of assent/consent signing.
- •If a cleanser, moisturizer or sunscreen is needed during the study, Subjects must be willing to use only allowed cleansers, moisturizers, sunscreens, or moisturizer/sunscreen combination products. If the subject wears makeup they must agree to use non-comedogenic makeup.
排除标准
- •Use of an investigational drug or device within 30 days of enrollment or participation in a research study concurrent with this study.
- •Any dermatological conditions on the face that could interfere with clinical evaluations such as acne conglobata, acne fulminans, secondary acne, perioral dermatitis, clinically significant rosacea, gramnegative folliculitis.
- •Any underlying disease(s) or some other dermatological condition of the face that requires the use of interfering topical or systemic therapy or makes evaluations and lesion count inconclusive.
- •Subjects with a facial beard or mustache that could interfere with the study assessments.
研究组 & 干预措施
IDP-120 Gel
Experimental
IDP-120 Gel is a combination treatment
干预措施: IDP-120 Gel (Drug)
IDP-120 Component A Gel
Active Comparator
IDP-120 Monad Gel of Component A
干预措施: IDP 120 Component A Gel (Drug)
IDP-120 Component B Gel
Active Comparator
IDP-120 Monad Gel of Component B
干预措施: IDP 120 Component B Gel (Drug)
IDP-120 Vehicle Gel
Placebo Comparator
IDP-120 Vehicle Gel
干预措施: IDP 120 Vehicle Gel (Drug)
结局指标
主要结局
Percent of subjects achieving clear or almost clear on the Evaluator's Global Severity Score.
时间窗: 12 Weeks
Percent of subjects who achieve at least a two-grade reduction from Baseline and are Clear or Almost Clear at Week 12 in the Evaluator's Global Severity Score.
次要结局
未报告次要终点
研究者
研究点 (24)
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