NCT03058744已完成1 期
A Phase 1b Open Label, Randomized Study Evaluating the Absorption and Systemic Pharmacokinetics and HPA Axis Suppression Potential of Topically Applied IDP-118 Lotion and HP Monad Lotion in Subjects With Moderate to Severe Plaque Psoriasis
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 94
- 试验地点
- 12
- 主要终点
- Local Skin Reactions (LSRs)
研究概览
简要总结
Suppression Potential of Topically Applied IDP-118 Lotion and HP Monad Lotion in Subjects with Moderate to Severe Plaque Psoriasis.
详细描述
A Phase 1b Open-Label, Randomized Study Evaluating the Absorption and Systemic Pharmacokinetics and HPA Axis Suppression Potential of Topically Applied IDP-118 Lotion and HP Monad Lotion in 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
- None
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 old of age (inclusive)
- •Freely provides both written and oral informed consent.
- •Has a clinical diagnosis of psoriasis at the Baseline visit with an Investigator's Global Assessment Score of 3 or
- •The face, scalp ,axillae, and intertriginous areas are to be excluded in this calculation.
- •Has an area of plaque psoriasis for topical treatment that involves a BSA of at least 20%.
- •The willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study.
排除标准
- •Has spontaneously improving or rapidly deteriorating plaque psoriasis or postural psoriasis, as determined by the investigator.
- •Presents with psoriasis that was treated with prescription medication and failed to respond to presents).
- •Has a history of adrenal disease.
- •Presents with any other concurrent skin conditions that could interfere with the evaluation of the treatment areas, as determined by the investigator.
- •Is pregnant, nursing, or planning pregnancy during the study period.
研究组 & 干预措施
IDP-118 Lotion
Experimental
8 Weeks
干预措施: IDP-118 Lotion (Drug)
HP Monad Lotion
Experimental
8 Weeks
干预措施: HP Monad Lotion (Drug)
Ultravate Cream
Active Comparator
2 Weeks
干预措施: Ultravate Cream (Drug)
Tazorac Cream
Active Comparator
4 Weeks
干预措施: Tazorac Cream (Drug)
结局指标
主要结局
Local Skin Reactions (LSRs)
时间窗: 8 Weeks
Tolerability will be evaluated through assessment of local signs and symptoms (itching, dryness, burning/stinging) on a scale of non, mild, moderate, and severe.
次要结局
未报告次要终点
研究者
研究点 (12)
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