A Multi-center, Double-blind, Randomized, Placebo-controlled, Parallel-group Study Comparing Ivermectin Cream 1% (Taro Pharmaceutical Industries, Inc.) To Soolantra™ Cream 1% (US Reference Listed Drug), PrRosiver® Cream 1% (Canadian Reference Product), and Each Active Treatments to a Placebo Control in the Treatment of Moderate to Severe Facial Rosacea.
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 865
- 试验地点
- 1
- 主要终点
- To demonstrate & evaluate the therapeutic, equivalence, and safety of the investigational product
研究概览
简要总结
The goal of this clinical trial is to evaluate and demonstrate the therapeutic equivalence and safety of Ivermectin Cream 1%, Soolantra™ Cream 1%, PrRosiver® Cream 1% & to Placebo for the treatment of moderate to severe facial rosacea.
详细描述
A multi-center, double-blind, randomized, placebo-controlled, parallel-group study, comparing Ivermectin Cream 1%, to Soolantra™ Cream 1%, PrRosiver® Cream 1% & to Placebo for the treatment of moderate to severe facial rosacea.
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
- Triple (Participant, Care Provider, Investigator)
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
- •Healthy male or non-pregnant female aged ≥ 18 with a clinical diagnosis of facial papulopustular rosacea.
- •Subjects must have provided IRB approved written informed consent.
- •Subjects must have a definite clinical diagnosis of facial papulopustular rosacea severity grade 3 or 4 as per the Investigator Global Assessment (IGA) (see Table 1 in the section 6.1)
- •Subjects must have at least 15 and not more than 50 inflammatory facial lesions (i.e., papules/pustules) AND ≤2 nodulocystic lesions (i.e., nodules and cysts).
排除标准
- •Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
- •Subjects with a history of hypersensitivity or allergy to ivermectin, propylene glycol, or any of the study medication ingredients.
- •Subjects with the presence of any skin condition that would interfere with the diagnosis or assessment of facial rosacea (e.g., on the face: rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin, & acne vulgaris).
- •Subjects who currently have or have recently had bacterial folliculitis on the face
研究组 & 干预措施
Ivermectin Cream 1%
The investigational product will be self-applied topically to the affected areas of the face once daily in the evening for 84 consecutive days.
干预措施: Ivermectin Cream 1% (Drug)
Soolantra™ Cream 1%
The investigational product will be self-applied topically to the affected areas of the face once daily in the evening for 84 consecutive days.
干预措施: Soolantra™ Cream 1% (Drug)
PrRosiver® Cream 1%
The investigational product will be self-applied topically to the affected areas of the face once daily in the evening for 84 consecutive days.
干预措施: PrRosiver® Cream 1% (Drug)
Placebo Control
The investigational product will be self-applied topically to the affected areas of the face once daily in the evening for 84 consecutive days.
干预措施: Placebo Control (Drug)
结局指标
主要结局
To demonstrate & evaluate the therapeutic, equivalence, and safety of the investigational product
时间窗: Baseline to Week 12
Percent change in the inflammatory (papules and pustules) lesion counts
次要结局
未报告次要终点