NCT05763082已完成3 期
Multi-Center, Double-Blind, Randomized, Vehicle-Controlled, Parallel-Group Study to Compare Padagis' Roflumilast Cream 0.3% to Arcutis's Zoryve™ (Roflumilast Cream 0.3%) Cream and Both Active Treatments to a Vehicle Control in the Treatment of Plaque Psoriasis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Padagis LLC
- 入组人数
- 416
- 试验地点
- 1
- 主要终点
- Investigator's Global Assessment (IGA)
研究概览
简要总结
To compare the safety and efficacy of Padagis' product to an FDA approved product for 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Signed IRB approved written informed consent/assent
- •12 to 75 years of age, inclusive.
- •Subjects must have a clinical diagnosis of stable symptomatic plaque psoriasis.
- •Baseline Investigator's Global Assessment Score of 3 (moderate).
- •Subjects must have a Body Surface Area (BSA) between 2% to 20%
- •Females of child bearing potential (excluding women who are surgically sterilized (tubal ligation or bilateral oophorectomy or hysterectomy) or post-menopausal for at least 2 years), in addition to having a negative urine pregnancy test at Visit 1/Day1(Baseline), must be willing to use an acceptable form of birth control during the study.
排除标准
- •Pregnant, breastfeeding or planning a pregnancy within the period of their study participation period.
- •Current diagnosis of unstable forms of psoriasis in the treatment area.
- •History of unresponsiveness to topical treatment for psoriasis
- •Presence of any other skin condition that, in the Investigator's opinion, might interfere with psoriasis diagnosis and/or evaluations
- •Any uncontrolled, chronic or serious disease or medical condition that would prevent participation in a clinical trial, or, in judgment of the investigator, would put the subject at undue risk or might confound the study assessments
- •Use of medicated make-up throughout the study and significant change in the use of consumer products within 30 days (1 month) of study entry and throughout the study
- •Subject consumes excessive alcohol, abuses drugs, or has a condition that could compromise the subject's ability to comply with study requirements.
- •Subjects who in the opinion of the investigator, are unlikely to be able to follow the restrictions of the protocol and complete the study
研究组 & 干预措施
Reference product
Active Comparator
干预措施: Zoryve (Drug)
Padagis active product
Experimental
干预措施: roflumilast cream 0.3% (Drug)
Padagis placebo product
Placebo Comparator
干预措施: Placebo (Drug)
结局指标
主要结局
Investigator's Global Assessment (IGA)
时间窗: Day 1 to Day 56
percentage of subjects at Day 56 who achieve Treatment Success, which is defined as an IGA score of None (0) or Minimal (1) with a 2-grade improvement from Day 1
次要结局
未报告次要终点
研究者
研究点 (1)
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