NCT01186068已完成2 期
A Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group Study of the Dose-Response Profile of V-101 Cream in Subjects With Erythematous Rosacea
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 175
- 试验地点
- 7
- 主要终点
- Clinician's Erythema Assessment
研究概览
简要总结
The purpose of this study is to evaluate the dose-response relationship (effect) of four concentrations of V-101 Cream in patients with erythematous(redness) rosacea.
详细描述
Patients must have moderate to severe erythematous (facial redness) rosacea
- Male and female patients must be at least 18 years old and in good general health
- Female patients must not be pregnant or nursing
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 females at least 18 years of age
- •diagnosis of stable erythematous rosacea
- •< 3 inflammatory lesions
- •in good general health
- •females must be non-pregnant and non-lactating
- •must be willing to sign a consent form
排除标准
- •have ocular, phymatous or other types of rosacea
- •allergy to any ingredient in study drug
- •participation in other investigational studies within 30 days of enrollment
- •use of systemic steroids within 28 days of Baseline
- •use of tetracycline antibiotics within 28 days of baseline
- •use of products containing oxymetazoline within 14 days of baseline
- •use of topical steroids witin treatment area 14 days prior to baseline
- •use of Rx or OTC products for treatment of acne or rosacea within 14 days of baseline
- •use of any product for reducing redness within the treatment area witin 14 days prior to baseline
- •use of monoamine oxidase (MAO) inhibitors
- •use of niacin >/= 500mg/day
研究组 & 干预措施
V-101 Cream 0.01% Concentration
Experimental
Low dose
干预措施: V-101 (Drug)
V-101 Cream 0.06% Concentration
Experimental
Mid-dose
干预措施: V-101 (Drug)
V-101 Cream 0.1% Concentration
Experimental
Mid-dose
干预措施: V-101 (Drug)
V-101 Cream 0.15% Concentration
Experimental
High dose
干预措施: V-101 (Drug)
Vehicle
Placebo Comparator
Cream without an active ingredient
干预措施: vehicle (Other)
结局指标
主要结局
Clinician's Erythema Assessment
时间窗: Day 28 visit
Physician visual evaluation
次要结局
- Subject's Self Assessment(28 Day Visit)
研究者
研究点 (7)
Loading locations...
相似试验
已完成
2 期
Efficacy and Safety of Different Concentrations of Mapracorat Ointment Over 4 Weeks in Atopic Dermatitis (AD)EczemaAtopic DermatitisNCT01359787Bayer197
已完成
2 期
Efficacy and Safety of Different Concentrations of ZK245186 in Atopic Dermatitis (AD)Atopic DermatitisNCT01228513Bayer263
已完成
2 期
Study to Evaluate SAGE-324 in Participants With Essential TremorEssential TremorNCT05173012Sage Therapeutics146
已完成
2 期
A Vehicle Controlled Study to Evaluate Safety and Efficacy of Topical TMB-001 for Treatment of Congenital IchthyosisCongenital IchthyosisNCT04154293LEO Pharma34
终止
2 期
An Efficacy and Safety Study of JNJ-26113100 in the Treatment of Adult Atopic DermatitisAtopic DermatitisNCT00455429Johnson & Johnson Pharmaceutical Research & Development, L.L.C.84