NCT04243486已完成2 期
A Multi-Center, Randomized, Double-Blind, Vehicle-Controlled, Parallel Group Study of the Safety and Efficacy of UHE-105 Shampoo in Subjects With Scalp 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
- 22
- 试验地点
- 2
- 主要终点
- Investigator's Global Assessment (IGA) Treatment Success
研究概览
简要总结
This study is to compare the safety and efficacy of UHE-105 Shampoo with that of the vehicle (VEH) Shampoo in subjects with scalp psoriasis. Half of the subjects will receive the UHE-105 Shampoo, while the other half will receive the VEH Shampoo with no active drug.
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
- •Subject is a male or non-pregnant female 18 years of age or older.
- •Subject has provided written informed consent.
- •Females must be post-menopausal , surgically sterile or use an effective method of birth control. , Women of childbearing potential must have a negative urine pregnancy test at Visit 1/Baseline.
- •Subject has a clinical diagnosis of stable moderate to severe scalp psoriasis affecting at least 10% of the scalp.
- •Subject is willing and able to apply the test article(s) as directed, comply with study instructions, and commit to all follow-up visits for the duration of the study.
- •Subject, in the investigator's opinion, is in good general health and free of any disease state or physical condition that might impair evaluation of scalp psoriasis or exposes the subject to an unacceptable risk by study participation.
排除标准
- •Subject is pregnant, lactating, or is planning to become pregnant during the study.
- •Subject has spontaneously improving or rapidly deteriorating scalp psoriasis.
- •Subject has guttate, pustular, erythrodermic, or other non-plaque forms of scalp psoriasis.
- •Subject has any physical condition which, in the investigator's opinion, could impair evaluation of scalp psoriasis, adrenal axis function (e.g., Addison's Disease, Cushing's Syndrome), or which exposes the subject to an unacceptable risk by study participation.
- •Subject has scalp psoriasis that necessitates systemic or other concomitant topical therapies during the study.
- •Subject has a history of psoriasis unresponsive to topical treatments.
- •Subject has any hair on their scalp of a length that extends beyond the subject's chin.
- •Subject has any open sores, lesions, cuts, or infections, etc. on the scalp or has had a scalp surgical procedure within the past 30 days.
- •Subject is currently enrolled in an investigational drug or device study.
- •Other protocol defined inclusion or exclusion criteria assessed by the study staff may apply.
研究组 & 干预措施
UHE-105 Shampoo
Experimental
UHE-105 Shampoo applied topically once daily to psoriatic lesions on the scalp for up to four (4) weeks
干预措施: UHE-105 (Drug)
Vehicle Shampoo
Placebo Comparator
Vehicle Shampoo applied topically once daily to psoriatic lesions on the scalp for up to four (4) weeks
干预措施: Vehicle (Drug)
结局指标
主要结局
Investigator's Global Assessment (IGA) Treatment Success
时间窗: Day 29
The percentage of subjects classified as IGA treatment success
次要结局
- Change in Percentage of scalp affected by psoriasis(Days 8, 15, and 29)
- Clinical signs of psoriasis (scaling, erythema and plaque elevation) Treatment Success(Days 8, 15, and 29)
- Percentage of subjects with pruritus severity score treatment success(Days 8, 15, and 29)
研究者
研究点 (2)
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