A Phase 2, Multicenter, Double-Blind, Randomized, Vehicle Controlled Clinical Study to Assess the Safety and Efficacy of IDP 118 in the Treatment of Plaque Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 212
- 试验地点
- 18
- 主要终点
- Percentage of Participants With Treatment Success of a 2-Grade IGA Score Improvement From Baseline and an IGA Score of Clear or Almost Clear 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
- Factorial
- 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, if psoriasis is present).
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
halobetasol propionate [HP], tazarotene [Taz]
干预措施: IDP-118 Lotion (Drug)
IDP-118 Monad HP Lotion
HP
干预措施: IDP-118 Monad HP Lotion (Drug)
IDP-118 Monad Taz Lotion
Taz
干预措施: IDP-118 Monad Taz Lotion (Drug)
IDP-118 Vehicle Lotion
Vehicle
干预措施: IDP-118 Vehicle Lotion (Drug)
结局指标
主要结局
Percentage of Participants With Treatment Success of a 2-Grade IGA Score Improvement From Baseline and an IGA Score of Clear or Almost Clear at Week 8
时间窗: 8 weeks
Treatment success defined as at least a 2-grade improvement from Baseline in the IGA score and an IGA score equating to "clear" or "almost clear" at Week 8. 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).
Percentage of Participants With Treatment Success of a 2-Grade IGA Score Improvement From Baseline and an IGA Score of Clear or Almost Clear at Weeks 2, 4, 6, and 12
时间窗: Weeks 2, 4, 6, and 12 (4-week follow-up)
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" at Weeks 2, 4, 6, and 12. 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