NCT02462070已完成3 期
A Phase 3, Multicenter, Double-Blind, Randomized, Vehicle Controlled Clinical Study to Assess the Safety and Efficacy of IDP-118 in the Treatment of Plaque Psoriasis
适应症
干预措施
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 203
- 试验地点
- 16
- 主要终点
- The Percentage of Participants With Treatment Success at Week 8
研究概览
简要总结
The objective of the study is to evaluate the safety and efficacy of a topical lotion.
详细描述
The objective of the study is to evaluate the safety and efficacy of a topical lotion when applied once daily to adult subjects with moderate to severe 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
- 否
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 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 score of 3 or
- •(The face, scalp, palms, soles, axillae and intertriginous areas are to be excluded in this assessment).
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 Vehicle Lotion
Active Comparator
Vehicle Lotion
干预措施: IDP-118 Vehicle Lotion (Drug)
IDP-118 Lotion
Experimental
Lotion
干预措施: IDP-118 Lotion (Drug)
结局指标
主要结局
The Percentage of Participants With Treatment Success at Week 8
时间窗: 8 weeks
Treatment success was defined as at least a 2-grade improvement from Baseline in IGA score and an IGA score equating to "Clear" or "Almost Clear". IGA was based on a 5-point scale ranging from 0 to 4; where 0 = clear, 1 = almost clear, 2 = mild, 3 = moderate, and 4 = severe.
次要结局
- Percentage of Participants With Treatment Success at Weeks 12, 6, 4, and 2(12 weeks)
研究者
研究点 (16)
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