Internet Surveys and Their Impact on Adherence and Quality of Life to Mirvaso for Rosacea
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- Adherence (% of Prescribed Doses That Were Actually Taken by the Subject)
研究概览
简要总结
An investigator-blinded, prospective, 6 month study of subjects with persistent erythema associated with active rosacea will be conducted in 20 subjects aged 18 years and older. All subjects will receive standard-of-care brimonidine topical gel, 0.33% with instructions to apply it once daily per package insert. Adherence will be assessed using weekly internet surveys to document how often the medication is being used, as well as reminders about rosacea triggers and general use of brimonidine.
详细描述
An investigator-blinded, prospective, 6 month study of subjects with persistent erythema associated with active rosacea will be conducted in 20 subjects aged 18 years and older. All subjects will receive standard-of-care brimonidine topical gel, 0.33% with instructions to apply it once daily per package insert. Adherence will be assessed using weekly internet surveys to document how often the medication is being used, as well as reminders about rosacea triggers and general use of brimonidine.Subjects will be randomized 1:1 to be in the weekly internet survey group or the standard care non-survey group.
At each visit, review of the internet survey use will be done to assess adherence to the medication. . Disease severity measures ((Clinician's Erythema Assessment (CEA), and Lesion counts will be obtained. QOL will be measured.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Single (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 subject with persistent erythema associated with rosacea, age greater than 18, who agrees to participate and provide written consent.
- •Have an Investigator Global Assessment of mild to moderate rosacea (IGA rating between 2 and 5 in the Investigator Global Assessment score which includes erythema in the assessment).
- •Access to a computer and the internet.
排除标准
- •Initiation or change in dose within 4 weeks of baseline of systemic anti-inflammatory medication which may influence study outcome.
- •Use of topical therapy for rosacea within 2 weeks of baseline.
- •Use of systemic corticosteroids within 4 weeks of baseline. Presence of a concurrent medical condition or skin condition, which is determined by the investigator to potentially interfere with study outcomes or patient assessments.
- •Subjects with known allergy or sensitivity to bromonidine topical gel, 0.33% or components therein.
- •Female subjects who are not postmenopausal for at least 1 year, surgically sterile, or willing to practice effective contraception during the study. Nursing mothers, pregnant women and women planning to become pregnant while on study are to be excluded.
- •Subjects with severe cardiovascular disease or vascular insufficiency.
研究组 & 干预措施
brimonidine topical gel 0.33% & survey
The internet survey will ask them how often they have used their medication that week, as well as giving them treatment tips and reminders about rosacea triggers. They will be asked a variety of questions during the weekly internet survey- such as the amount of erythema they currently have (measured by VAS scale), how much burning and stinging they have, how often they have used the medication and where did they apply the medication, as well as any additional side effects they may be having from the medication.
干预措施: brimonidine topical gel 0.33% & survey (Drug)
brimonidine topical gel 0.33% & survey
The internet survey will ask them how often they have used their medication that week, as well as giving them treatment tips and reminders about rosacea triggers. They will be asked a variety of questions during the weekly internet survey- such as the amount of erythema they currently have (measured by VAS scale), how much burning and stinging they have, how often they have used the medication and where did they apply the medication, as well as any additional side effects they may be having from the medication.
干预措施: brimonidine topical gel 0.33% & SOC (Drug)
brimonidine topical gel 0.33% & SOC
Topical drug and standard of care follow-up, no weekly survey; only survey during 3 month and 6 month visits
干预措施: brimonidine topical gel 0.33% & SOC (Drug)
结局指标
主要结局
Adherence (% of Prescribed Doses That Were Actually Taken by the Subject)
时间窗: 6 months
To assess adherence to topical brimonidine for the treatment of rosacea as measured by MEMS caps. The result will be the % of prescribed doses that were actually taken by the subject
次要结局
- Dermatology Life Quality Index(baseline and 6 months)
- Lesion Count(Baseline and 6 months)
- Clinician Erythema Assessment Scale(baseline and 6 months)
- Quality of Life (Measured by General Survey of Impact of Rosacea on Everyday Activities)(baseline and 6 months)
- Patient Severity Assessment (PSA)(baseline and 6 months)
- Quality of Life With Rosacea(baseline and 6 months)