A Phase 2, Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group Study Evaluating the Safety, Tolerability, and Efficacy of TP-04 in Participants With Papulopustular Rosacea
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 37
- 试验地点
- 5
- 主要终点
- The incidence of treatment emergent adverse events from baseline
研究概览
简要总结
This study is being done to evaluate the safety, tolerability, and efficacy of the study drug, TP-04, in participants with papulopustular rosacea (PPR).
详细描述
This is a Phase 2, multicenter, randomized, double-blind, parallel-group, vehicle-controlled study evaluating the safety, tolerability, and efficacy of Lotilaner Gel, 2.0% (TP-04) applied BID for 12 weeks in participants with moderate to severe PPR.
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)
盲法说明
Double-Blind, Vehicle-Controlled
入排标准
- 年龄范围
- 18 Years 至 59 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Lotilaner Gel, 2.0% (TP-04)
Participants will be randomized to a 2:1 ratio at baseline to apply Lotilaner Gel, 2.0% (TP-04) on the face BID for 12 weeks.
干预措施: Lotilaner Gel, 2.0% (Drug)
Vehicle-Controlled
Participants will be randomized to a 2:1 ratio at baseline to apply vehicle control gel on the face BID for 12 weeks.
干预措施: Vehicle control gel (Other)
结局指标
主要结局
The incidence of treatment emergent adverse events from baseline
时间窗: Week 1 through Week 12
Incidence of local and systemic TEAEs while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel from baseline
Changes from baseline in vital signs change in pulse in beats per minute
时间窗: Week 1 through Week 12
Changes from baseline in vital signs change in pulse in beats per minute while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel
Changes in hematology laboratory assessments from baseline
时间窗: Week 1 through Week 12
Changes from baseline hematology laboratory values while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel
Changes from baseline in vital signs change in height in cm
时间窗: Week 1 through Week 12
Changes from baseline in vital signs change in height in cm while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel
Changes from baseline in vital signs change in weight in kg
时间窗: Week 1 through Week 12
Changes from baseline in vital signs change in weight in kg while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel
Changes from baseline in vtial signs change in systolic/diastolic blood pressure in mmHg
时间窗: Week 1 through Week 12
Changes from baseline in vital signs change in systolic/diastolic blood pressure in mmHg while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel
Changes from baseline in vital signs change in temperature in Celsius
时间窗: Week 1 through Week 12
Changes from baseline in vital signs change in temperature in Celsius while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel
Changes from baseline in ECGs change in mean ventricular rate (beats/min)
时间窗: Week 1 through Week 12
Changes from baseline in ECGs change in mean ventricular rate (beats/min) while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel
Local tolerability assessment ((0=none, 3=severe): dryness, scaling, erythema, burning/stinging; itching)
时间窗: Week 1 through Week 12
Evaluate local tolerability assessment ((0=none, 3=severe): dryness, scaling, erythema, burning/stinging; itching) of Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel
Changes from baseline in vital signs change in respiratory rate in breaths per minute
时间窗: Week 1 through Week 12
Changes from baseline in vital signs change in respiratory rate in breaths per minute while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel
Changes in clinical chemistry laboratory assessments from baseline
时间窗: Week 1 through Week 12
Changes from baseline clinical chemistry laboratory values while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel
Change from baseline in ECGs change in QRS interval in msec
时间窗: Week 1 through Week 12
Changes from baseline in ECGs change in QRS interval in msec while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel
Changes in baseline in ECGs change in QTC interval in msec
时间窗: Week 1 through Week 12
Changes from baseline in ECGs change in QTC interval in msec while using Lotilaner Gel, 2.0% (TP-04) versus vehicle control gel
次要结局
- Facial inflammatory lesion counts - percent change from baseline(Week 1 through Week 12)
- Improvement in Worst Pruritus Numeric Rating Scale (NRS) Score (0=no itch; 10= worst imaginable itch)(Week 1 through Week 12)
- Improvement in Investigator Global Assessment (IGA) score (0=clear; 4=severe)(Week 1 through Week 12)
- Facial Inflammatory lesion counts - absolute change from baseline(Week 1 through Week 12)
- Investigator Global Assessmen (IGA) Score (0=clear; 4=severe) - absolute change from baseline(Week 1 through Week 12)
- Clinician Erythema Assessment (CEA) Score (0=clear; 4=severe) - absolute change from baseline(Week 1 through Week 12)
- Pruritus Numeric Rating Scale (NRS) Score (0=no itch; 10= worst imaginable itch) - absolute change from baseline(Week 1 through Week 12)
- Worst Pain Numeric Rating Scale (NRS) Score (0=no pain; 10= worst imaginable pain) - absolute change from baseline(Week 1 through Week 12)