A Phase 4, Open-Label, Multicenter Study Evaluating the Absorption and Systemic Pharmacokinetics and HPA Axis Suppression Potential of Topically Applied IDP-122 Lotion in Pediatric Subjects With Moderate to Severe Plaque Psoriasis
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 45
- 试验地点
- 9
- 主要终点
- Pharmacokinetics: Maximum Observed Drug (Halobetasol Propionate) Concentration in Plasma (Cmax) of IDP-122 Lotion Analytes
研究概览
简要总结
This study is to evaluate the safety, the systemic exposure of halobetasol propionate (HP), and the hypothalamic-pituitary-adrenal (HPA) axis suppression potential for topically applied IDP-122 lotion in pediatric participants with moderate to severe plaque psoriasis.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Is 6 to 16 years 11 months of age at time of informed consent/assent obtained.
- •Verbal and written informed consent/assent obtained from the participant and/or parent or legal guardian.
- •Has a clinical diagnosis of psoriasis at Screening and Baseline with an Investigator's Global Assessment (IGA) score of 3 or
- •The face, scalp, axillae, and intertriginous areas are to be excluded in this assessment, if psoriasis is present.
- •Has an area of plaque psoriasis appropriate for topical treatment that involves a BSA of at least 10% at Screening and Baseline. The face, scalp, 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.
- •Is in good general adrenal health, as determined by a 30-minute postcosyntropin stimulation serum cortisol level that is >18 μg/dL at the Screening visit.
- •Females of childbearing potential and females who are pre-menses (9 years and older) must be willing to practice effective contraception for the duration of the study.
排除标准
- •Has a history of adrenal disease.
- •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 baseline or is concurrently participating in another clinical study with an investigational drug or device.
- •Received treatment with a topical antipsoriatic drug product other than corticosteroids within 14 days prior to the Baseline visit and/or treatment containing corticosteroids within 28 days prior to the screening HPA axis stimulation test.
- •Has a history of hypersensitivity or allergic reaction to any of the study drug constituents.
- •Is considered by the Investigator, for any other reason, to be an unsuitable candidate for the study.
研究组 & 干预措施
IDP-122 Lotion
Two cohorts of pediatric participants (1 cohort of participants age 12 to 16 years 11 months and 1 cohort of participants age 6 to 11 years 11 months) will apply IDP-122 Lotion to Investigator identified lesions affecting a minimum of 10% body surface area (BSA) once daily for 8 weeks.
干预措施: IDP-122 Lotion (Drug)
结局指标
主要结局
Pharmacokinetics: Maximum Observed Drug (Halobetasol Propionate) Concentration in Plasma (Cmax) of IDP-122 Lotion Analytes
时间窗: 0 (predose), 1, 2, 4, 8, 12, and 24 hours postdose
On Days 28-29, blood samples will be collected from each participant for the determination of plasma concentrations and PK parameters of IDP-122 Lotion analytes.
次要结局
- Proportion of Participants With Hypothalamic-Pituitary-Adrenal (HPA) Axis Suppression(Week 8)