An Open Label, Comparative Evaluation of the Adrenal Suppression Potential and Pharmacokinetic Properties of 188-0551 Spray Versus Reference Listed Drug (RLD) Applied Every 12 Hours for 2 Weeks in Subjects With Moderate to Severe Plaque Psoriasis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 55
- 试验地点
- 8
- 主要终点
- The proportion of subjects to exhibit adrenal suppression as measured by a cortrosyn stimulation test
研究概览
简要总结
Adrenal suppression effects of corticosteroids are among the most important safety concerns for this group of products. This study is to determine and compare the adrenal suppression potential and the pharmacokinetic (PK) properties of 188-0551 Spray versus an FDA-approved drug (also known as a "Reference Listed Drug" [RLD]) under maximal use conditions when applied twice daily (approximately every 12 hours) in adult subjects with stable, 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
- •Subject is a male or non-pregnant female and is at least 18 years of age at the time of informed consent.
- •Subject has provided written informed consent.
- •Subject has moderate or severe psoriasis involving a minimum of 20% Body Surface Area (BSA).
- •Subject has an Investigator's Global Assessment (IGA) score of at least three (3 = moderate) at the Baseline Visit.
排除标准
- •Subject is pregnant, lactating, or is planning to become pregnant during the study.
- •Subject has spontaneously improving or rapidly deteriorating plaque psoriasis.
- •Subject has a physical condition which, in the investigator's opinion, might impair evaluation of plaque psoriasis, adrenal axis function or which exposes the subject to an unacceptable risk by study participation.
- •Subject has had prolonged exposure to natural or artificial sources of ultraviolet radiation.
- •Subject is currently enrolled in an investigational drug or device study.
- •Subject has clinically significant abnormal labs at Visit 1/Screening that precludes topical steroid use, in the opinion of the investigator.
研究组 & 干预措施
188-0551 Spray
Investigational Topical Spray Product
干预措施: 188-0551 Spray (Drug)
Reference Listed Drug (RLD)
FDA Approved Topical Cream
干预措施: RLD (Drug)
结局指标
主要结局
The proportion of subjects to exhibit adrenal suppression as measured by a cortrosyn stimulation test
时间窗: Day 15
A subject is considered to have adrenal suppression evidence if post stimulation lab draw result is ≤ 18 µg/dL (497 nmol/L).
次要结局
未报告次要终点