NCT01872715已完成4 期
Patient Centered Outcomes in Rosacea: An Exploratory Multi-media Analysis of the Patient Experience on Oracea
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 24
- 试验地点
- 1
- 主要终点
- Rosacea Score on the Visual Analog Scale
研究概览
简要总结
The purpose of this study is to characterize rosacea patients', being treated with Oracea, perception through visual analog scale reporting.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 25 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men and women
- •25-70 years
- •Diagnosis of papulopustular rosacea
- •Eligible for Oracea treatment
排除标准
- •Allergies to components of investigational product and/or hypersensitivity to tetracyclines
- •Taken systemic therapy directed at improving rosacea, including antibiotics, within 30 days prior to baseline visit
- •Used topical rosacea treatment within 30 days prior to baseline visit
- •Have active ocular rosacea and/or blepharitis/meibomianitis requiring systemic treatment by an opthalmologist
- •Previously failed to have improvement of rosacea with appropriate use of systemic tetracycline family of antibiotics
- •Exposed to intense/excessive ultraviolet (UV) radiation within one week prior to baseline and/or who forsee unprotected and intense/excessive UV exposure during the course of the study
- •Have planned surgical procedures during the course of the study
- •Have used tetracycline antibiotics within 30 days prior to baseline visit or during study
- •At risk in terms of precautions, warnings, and contraindications
研究组 & 干预措施
Oracea
Experimental
Oracea (doxycycline USP, 40mg[30mg immediate release/ 10mg delayed release beads] taken once daily in the morning on an empty stomach, one hour before meals or two hours after.
Oral dose for 12 weeks
干预措施: Oracea (Drug)
结局指标
主要结局
Rosacea Score on the Visual Analog Scale
时间窗: Baseline, Weeks 2, 6, and 12
VAS = visual analog scale, 10 cm scale in which 0 = no rosacea, 10 = worst rosacea imaginable
次要结局
- Rosacea-Specific Quality of Life Index(Baseline, Weeks 2, 6, and 12)
- Patient Global Assessment (PGA) of Rosacea Scores(Baseline, Weeks 2, 6, and 12)
- Patient Satisfaction Question(Week 2, 6, and 12)
研究者
研究点 (1)
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