Randomized, Double-Blind, Parallel-Group, Vehicle-Controlled, Dose-Finding Study Investigating the Pharmacodynamics and Safety of Three Concentrations of CD07805/47 Topical Gel (0.07%, 0.18%, and 0.50%), Applied in Subjects With Moderate to Severe Erythematotelangiectatic Rosacea
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 122
- 试验地点
- 5
- 主要终点
- Response Rate for Achieving a 2 Grade Improvement on Clinician's Erythema Assessment (CEA) and Patient Self Assessment (PSA) Over 12 Hours After Dosing.
研究概览
简要总结
This is a randomized, double-blind, parallel-group, vehicle-controlled, dose-finding study to investigate the pharmacodynamics and the safety of three dosages of CD07805/47 topical gel (0.07%, 0.18%, and 0.50%), after a single application in subjects with a clinical diagnosis of stable moderate to severe erythematotelangiectatic rosacea. Subjects will be randomized in a 1:1:1:1 ratio to receive either one of three CD07805/47 topical gel concentrations (0.07%, 0.18%, or 0.50%) or Vehicle Gel. All subjects will be treated with a single application (once daily dosing for one day) of study medication.
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 who is at least 18 years of age.
- •Clinical diagnosis of stable moderate to severe erythematotelangiectatic rosacea.
- •CEA (clinician's erythema assessment) score greater than or equal to 3 at Screening and on Treatment visit at baseline.
- •PSA (patient self assessment) score of greater than or equal to 3 at Screening and on Treatment visit at baseline.
- •Presence of 2 or fewer inflammatory facial lesions.
排除标准
- •History of Raynaud's Syndrome, glaucoma, orthostatic hypotension, thromboangiitis obliterans, cerebral or coronary insufficiency, or depression.
- •History of refractive surgery such as photorefractive keratectomy.
- •The subject is being treated with monoamine oxidase (MAO) inhibitor, anti-depressants, barbiturates, opiates, sedatives, systemic anesthetics, alpha-agonists, beta blockers, antihypertensive agents, cardiac glycosides, or systemic anticoagulants.
- •The subject is currently enrolled in an investigational drug or device study or participated in such a study in the past 3 months prior to enrollment and is still in the exclusion period on the day of the Treatment visit.
研究组 & 干预措施
CD07805/47 0.5% Topical Gel
0.5% Topical Gel
干预措施: CD07805/47 (Drug)
CD07805/47 0.18% Topical Gel
0.18% Topical Gel
干预措施: CD07805/47 (Drug)
CD07805/47 0.07% Topical Gel
0.07% Topical Gel
干预措施: CD07805/47 (Drug)
CD07805/47 Vehicle Topical Gel
Vehicle Topical Gel
干预措施: CD07805/47 placebo (Drug)
结局指标
主要结局
Response Rate for Achieving a 2 Grade Improvement on Clinician's Erythema Assessment (CEA) and Patient Self Assessment (PSA) Over 12 Hours After Dosing.
时间窗: Baseline and every hour for 12 hours following application
次要结局
未报告次要终点