Efficacy and Safety of Ivermectin 1% Topical Cream Associated With Brimonidine 0.33% Topical Gel in the Treatment of Moderate to Severe Rosacea
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 190
- 主要终点
- Efficacy Variable: Percentage of Patients Defined as Success on the Global Rosacea Severity Grading Scale Called Investigator's Global Assessment (IGA):
研究概览
简要总结
The main objective of this study is to evaluate the efficacy of Ivermectin 1% cream (IVM) associated with Brimonidine 0.33% gel (Br) compared with the association of their respective vehicles in the treatment of moderate to severe 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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- •Male or female subjects age 18 years or older;
- •Subjects with a minimum of 15 but not more than 70 inflammatory lesions (papules and pustules) of rosacea on the face;
- •Subjects with moderate or severe diffuse persistent facial erythema of rosacea (scored 3 or 4 according to Clinician's Erythema Assessment [CEA]);
- •Subjects with moderate or severe papulopustular rosacea (scored 3 or 4 according to the Investigator's Global Assessment [IGA]);
- •Female subjects of childbearing potential with a negative urine pregnancy test (UPT);
- •Female subjects of childbearing potential must practice a highly effective method of contraception during the study;
- •Females subjects of non-childbearing potential;
排除标准
- •Subjects with particular forms of rosacea or other concomitant facial dermatoses that may be confounded with rosacea;
- •Subjects with more than 2 nodules of rosacea on the face;
- •Subjects with any uncontrolled chronic or serious disease or medical condition that may either interfere with the interpretation of the clinical trial results, or with optimal participation in the study or would present a significant risk to the subject;
- •Subjects with known or suspected allergies or sensitivities to any component of the investigational and non-investigational products, including the active ingredients brimonidine or salts of brimonidine like brimonidine tartrate and ivermectin;
研究组 & 干预措施
Brimonidine 0.33% gel / CD07805/47 (Br) + Ivermectin 1% cream
Half group will receive once-daily Br 0.33% gel in the morning and once-daily IVM 1% cream in the evening for 12 weeks.
Half group will receive once-daily Br vehicle gel in the morning for the first 4 weeks and once-daily Br 0.33% gel in the morning for the following 8 weeks and once-daily IVM 1% cream in the evening for 12 weeks.
干预措施: Brimonidine 0.33% gel (Br) (Drug)
Brimonidine 0.33% gel / CD07805/47 (Br) + Ivermectin 1% cream
Half group will receive once-daily Br 0.33% gel in the morning and once-daily IVM 1% cream in the evening for 12 weeks.
Half group will receive once-daily Br vehicle gel in the morning for the first 4 weeks and once-daily Br 0.33% gel in the morning for the following 8 weeks and once-daily IVM 1% cream in the evening for 12 weeks.
干预措施: CD07805/47 (Br) placebo gel (Other)
Brimonidine 0.33% gel / CD07805/47 (Br) + Ivermectin 1% cream
Half group will receive once-daily Br 0.33% gel in the morning and once-daily IVM 1% cream in the evening for 12 weeks.
Half group will receive once-daily Br vehicle gel in the morning for the first 4 weeks and once-daily Br 0.33% gel in the morning for the following 8 weeks and once-daily IVM 1% cream in the evening for 12 weeks.
干预措施: Ivermectin 1% cream (IVM) (Drug)
CD07805/47 (Br) placebo gel + CD5024 (IVM) placebo cream
Subjects will receive once-daily Br vehicle gel in the morning and once-daily IVM vehicle cream in the evening for 12 weeks.
干预措施: CD07805/47 (Br) placebo gel (Other)
CD07805/47 (Br) placebo gel + CD5024 (IVM) placebo cream
Subjects will receive once-daily Br vehicle gel in the morning and once-daily IVM vehicle cream in the evening for 12 weeks.
干预措施: CD5024 (IVM) placebo cream (Other)
结局指标
主要结局
Efficacy Variable: Percentage of Patients Defined as Success on the Global Rosacea Severity Grading Scale Called Investigator's Global Assessment (IGA):
时间窗: week 12/Hour 3
Percentage of patients defined as success as per scores of IGA; ie: clear (score=0) or almost clear (score=1)
次要结局
未报告次要终点