NCT02785172已完成2 期
A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study to Compare the Safety and Efficacy of IDP-118 Lotion to Ultravate® in the Treatment of Plaque Psoriasis
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
- 154
- 试验地点
- 14
- 主要终点
- Percent of Subjects With Treatment Success
研究概览
简要总结
Safety and Efficacy of IDP-118 Lotion to Ultravate® Cream, in the Treatment of Plaque Psoriasis
详细描述
A Phase 2, Multi-Center, Double-Blind, Randomized, Vehicle-Controlled Study to Compare the Safety and Efficacy of IDP-118 Lotion to Ultravate® Cream, in the Treatment of Plaque Psoriasis
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female, of any race, at least 18 years of age (inclusive).
- •Freely provides both verbal and written informed consent.
- •Has an area of plaque psoriasis appropriate for topical treatment that covers a BSA (Body Surface Area) of at least 3%, but no more than 12%. The face, scalp, palms, soles, axillae, and intertriginous areas are to be excluded in this calculation.
- •Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study.
- •Has a clinical diagnosis of psoriasis at the Baseline visit with an IGA (Investigators Global Assessment) score of 3 or
- •(The face, scalp, palms, soles, axillae, and intertriginous areas are to be excluded in this assessment, if psoriasis is present.)
- •If female and of childbearing potential, must have a negative urine and serum pregnancy test at the Screening visit and negative urine pregnancy at Baseline visit prior to randomization.
- •Subject is willing to comply with study instructions and return to the clinic for required visits.
排除标准
- •Has spontaneously improving or rapidly deteriorating plaque psoriasis or pustular psoriasis, as determined by the investigator.
- •Presents with psoriasis that was treated with prescription medication and failed to respond to treatment, even partially or temporarily, as determined by the investigator.
- •Presents with any concurrent skin condition that could interfere with the evaluation of the treatment areas, as determined by the investigator.
- •Is pregnant, nursing an infant, or planning a pregnancy during the study period.
- •Has received treatment with any investigational drug or device within 60 days or 5 drug half-lives (whichever is longer) prior to the Baseline visit, or is concurrently participating in another clinical study with an investigational drug or device.
研究组 & 干预措施
IDP-118 Lotion
Experimental
Lotion
干预措施: IDP-118 Lotion (Drug)
Ultravate Cream
Active Comparator
Cream
干预措施: Ultravate Cream (Drug)
IDP-118 Vehicle Lotion
Active Comparator
Lotion
干预措施: IDP-118 Vehicle Lotion (Drug)
IDP-118 Vehicle Cream
Active Comparator
Cream
干预措施: IDP-118 Vehicle Cream (Drug)
结局指标
主要结局
Percent of Subjects With Treatment Success
时间窗: 2 weeks
Treatment success defined as at least a 2-grade improvement from Baseline in the Investigator's Global Assessment (IGA) score and an IGA score equating to "clear" or "almost clear". The IGA score was based on a 5-point scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe).
次要结局
未报告次要终点
研究者
研究点 (14)
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