NCT06631170已完成3 期
A Phase 3 Multicenter, Double-blind, Vehicle-controlled Brigding Study to Evaluate the Efficacy and Safety of Roflumilast Cream 0.15% (ZORYVE®) in the Treatment of Patients With Mild to Moderate Atopic Dermatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 354
- 试验地点
- 61
- 主要终点
- Percentage of subjects with vIGA-AD success
研究概览
简要总结
This study will assess the safety and efficacy of Roflumilast cream versus vehicle applied once a day for 4 weeks by subjects with atopic dermatitis.
详细描述
This is a parallel group, double blind, vehicle-controlled study in which Roflumilast cream or vehicle is applied once daily for 4 weeks to subjects with mild or moderate atopic dermatitis.
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
- 6 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects aged ≥ 6 years at screening.
- •Diagnosed with atopic dermatitis (AD) for at least 6 months for subjects aged ≥18 years and 3 months for subjects aged 6~17 years at screening.
- •Have stable disease for the past 4 weeks prior to screening.
- •Have mild or moderate AD at baseline.
- •Have BSA affected by AD of 3%-20% at baseline.
- •Women of childbearing potential (WOCBP) have a negative pregnancy blood test at screening and a negative urine pregnancy test at baseline. WOCBP must have taken and agree to continue taking highly effective contraceptive measures from 4 weeks before the first dose to 2 months after the last dose.
- •Being in good health as judged by the Investigator.
- •Subjects voluntarily participate in the study and sign the ICF before the start of study-related activities.
排除标准
- •Subjects with any serious medical condition or clinically significant abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator.
- •Previous treatment with roflumilast cream.
- •Use of systemic treatments that affect the efficacy assessment of AD 4 weeks or 5 half-lives (whichever is longer) prior to the first dose.
- •Use of topical treatments that affect the efficacy assessment of AD 2 weeks prior to the first dose.
- •Use of phototherapy, tanning beds, or any other light-emitting devices within 4 weeks prior to the first dose.
- •Female subjects who are pregnant or breastfeeding, or plan to become pregnant or breastfeed during the study.
- •Subjects with a history of chronic alcohol or drug abuse within 6 months prior to Screening.
- •Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members of enrolled subjects living in the same house.
- •Subjects/legal guardians who are unable to communicate, understand the study, or other situations deemed inappropriate for participation in a clinical trial by the investigator.
研究组 & 干预措施
Roflumilast cream 0.15%
Experimental
Active comparator
干预措施: Roflumilast Cream 0.15% (Drug)
Vehicle cream
Placebo Comparator
Placebo comparator
干预措施: Vehicle cream (Drug)
结局指标
主要结局
Percentage of subjects with vIGA-AD success
时间窗: Baseline, week 4
The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4 where 0 is clear). IGA sucess is defined as a vIGA-AD score of 'clear' or 'almost clear' plus at least 2-grade improvement from baseline
次要结局
- In subjects with moderate AD severity (vIGA-AD score of 3) at baseline, percentage of subjects with vIGA-AD success(Baseline, week 4)
- Percentage of subjects with vIGA-AD of "clear" or "almost clear"(Baseline, week 4)
- In subjects with WI-NRS ≥ 4 at baseline, percentage of subjects with ≥ 4 point reduction in WI-NRS(Baseline, week 4)
- Percentage of subjects with at least 75% reduction in the Eczema Area and Severity Index (EASI-75)(Baseline, week 4)
- Safety: treatment emergence adverse events(Up to 4 weeks)
- Trough concentration (Ctrough)(Week 2, week 4)
研究者
研究点 (61)
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