NCT05148689已完成1 期
A Double-blind, Randomized, Placebo Controlled Study, Comparing Oxymetazoline 1% Cream TO RHOFADE in the Treatment of Moderate to Severe Persistent Facial Erythema Assocoated With Rosacea
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 82
- 试验地点
- 1
- 主要终点
- erythema response success
研究概览
简要总结
randomized, double-blind, placebo controlled
详细描述
Subjects in this randomized, double-blind, placebo controlled study will be randomly assigned to treatment sequences with the test product, reference product or placebo control.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 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
- •Healthy male or non-pregnant female aged ≥18 years with a clinical diagnosis of facial rosacea;
- •Provided IRB approved written informed consent;
- •A CEA score of ≥3 prior to study drug application
- •A PSA score of ≥3 prior to study drug application
排除标准
- •Female subjects who were pregnant, nursing, or had planned to become pregnant during study participation;
- •History of hypersensitivity to the study product;
- •Presence of ≥3 facial inflammatory lesions of rosacea;
- •Particular forms of rosacea (rosacea conglobata, rosacea fulminans, isolated rhinophyma, and isolated pustulosis of the chin);
- •Raynaud's syndrome, thromboangiitis obliterans, orthostatic hypotension, severe cardiovascular disease, cerebral or coronary insufficiency, renal or hepatic impairment, scleroderma, Sjögren's syndrome, or depression;
- •Excessive facial hair (e.g., beards, sideburns, moustaches, etc.) that could interfere with diagnosis or study assessments;
- •Presence of significant hypertension or circulatory disease
研究组 & 干预措施
test product
Experimental
Oxymetazoline Cream, 1%
干预措施: Oxymetazoline hydrochloride Cream, 1% (Drug)
reference
Active Comparator
Rhofade™ (oxymetazoline) cream, 1%
干预措施: Rhofade™ (oxymetazoline) cream, 1% (Drug)
placebo
Placebo Comparator
Vehicle of Test product
干预措施: Placebo (Drug)
结局指标
主要结局
erythema response success
时间窗: 21 day
at least a 2-grade improvement in both CEA and PSA
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
•Research study to investigate the safety, tolerability and effects of multiple doses of LTI-291 in patients with Parkinson’s Disease with a GBA1 mutation.PD patients with a GBA1 mutation , movement disorderNL-OMON23923•Lysosomal Therapeutics, Incorporated40
尚未招募
不适用
Pharmacological effects on nerve excitability in healthy volunteers•PainNL-OMON25429•Centre for Human Drug Research, Leiden18
招募中
不适用
The FCATFibromyalgiaNL-OMON28585eiden University Medical Center (LUMC)40
招募中
不适用
The LCAT studyow back painNL-OMON26947eiden University Medical Center (LUMC)40
招募中
3 期
Clinical Trial of Mycobacterium w in Preventing COVID-19 in Subjects at Risk of Getting Infected With COVID-19CTRI/2020/05/025277Cadila Pharmaceuticals Limited