NCT01789775已完成3 期
Phase 3 Efficacy and Safety Study of CD07805/47 Topical Gel in Subjects With Facial Erythema of Rosacea
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 114
- 试验地点
- 1
- 主要终点
- Composite Success Assessment (CEA) and Patient Self Assessment(PSA).
研究概览
简要总结
Phase 3 efficacy and safety study of CD07805/47 topical gel in subjects with facial erythema associated with rosacea. The study hypothesis is that CD07805/47 gel, applied topically once daily is more efficacious than vehicle and provides an acceptable safety profile in the treatment of facial erythema associated with 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
- Double (Participant, 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
- •Male or female who is at least 18 years of age or older.
- •A clinical diagnosis of facial rosacea.
- •A Clinician Erythema Assessment (CEA) score of greater than or equal to 3 at Screening and at Baseline/Day 1 (prior to the study drug application).
- •A Patient Self Assessment (PSA) score of greater than or equal to 3 at Screening and at Baseline/Day 1 (prior to the study drug application).
排除标准
- •More than 20 facial inflammatory lesions of rosacea
- •Particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, isolated pustulosis of the chin) or other concomitant facial dermatoses that are similar to rosacea such as peri-oral dermatitis, demodicidosis, facial keratosis pilaris, seborrheic dermatitis, acute lupus erythematosus, or actinic telangiectasia.
- •Current treatment with monoamine oxidase (MAO) inhibitors, barbiturates, opiates, sedatives, systemic anesthetics, or alpha agonists.
- •Less than 3 months stable dose treatment with tricyclic anti depressants, cardiac glycosides, beta blockers or other antihypertensive agents.
- •Current diagnosis of Raynaud's syndrome, thromboangiitis obliterans, orthostatic hypotension, severe cardiovascular disease, cerebral or coronary insufficiency, renal or hepatic impairment, scleroderma, Sjögren's syndrome, or depression.
研究组 & 干预措施
CD07805/47 gel
Experimental
Intervention: Drug: CD07805/47 gel
干预措施: CD07805/47 gel Placebo (Drug)
结局指标
主要结局
Composite Success Assessment (CEA) and Patient Self Assessment(PSA).
时间窗: Day 29
Composite Success is defined as 1-grade improvement on both Clinician Erythema Assessment (CEA) and Patient Self Assessment(PSA).
次要结局
- Composite Success Assessment (CEA) and Patient Self Assessment(PSA).(D1)
研究者
研究点 (1)
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