Cutaneous Lupus Medication Experience Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 11
- 试验地点
- 1
- 主要终点
- Change in Adherence Measures
研究概览
简要总结
Cutaneous lupus is a chronic, relapsing, auto-immune skin disease that can have many presentations. Its effect on physical appearance greatly affects patients' quality of life. In addition, 10% of patients with cutaneous lupus will develop systemic lupus. Topical therapies are the mainstay of cutaneous lupus treatment; however patients often find these treatments to be messy, inconvenient, or ineffective. In addition, for more severe disease patients are often placed on concurrent systemic therapies. The primary hypothesis of our study is that poor adherence contributes to poor treatment outcomes in patients with cutaneous lupus.
详细描述
Cutaneous lupus is a chronic, relapsing auto-immune disease that negatively impacts patients' quality of life. As there are many safe topical therapies that require daily use to be effective, and adherence to medication remains a common problem in dermatology, it is worthwhile to reliably measure adherence to medication in patients with cutaneous lupus. By elucidating barriers to effective control of cutaneous lupus with topical medications, we can improve patient care and guide interventions that will avoid the use of systemic therapy which often has more side effects.
The primary aim is to determine adherence to topical and systemic lupus treatment. Subjects will receive standard of care therapy (low potency and high potency topical corticosteroids) and systemic therapy when clinically appropriate. Adherence to medications will be monitored electronically in all subjects. The following hypothesis is to be tested: Non-adherence to topical and systemic medication contributes to treatment failure in patients with cutaneous lupus.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Any male or female 12 years or older of age with a diagnosis of cutaneous lupus by a dermatologist
- •Capable of understanding and willing to provide a signed and dated written voluntary informed consent before any protocol specific procedures are performed
- •Able to complete the study and comply with study instructions, including attending all study visits
排除标准
- •Individuals younger than 12 years of age
- •Known allergy or sensitivity to study medication
- •Inability to complete all study-related visits
- •Introduction of any other prescription medication, topical or systemic, for cutaneous lupus while participating in the study
研究组 & 干预措施
Lupus control standard-of-care
Each person enrolled will be given fluocinonide 0.05% cream to apply twice daily to active areas.
干预措施: fluocinonide 0.05% cream (Drug)
结局指标
主要结局
Change in Adherence Measures
时间窗: up to 6 month
There will be interim measures taken after the baseline measure at month 1, month 3, and at end point month 6.
次要结局
- Disease Severity Measures(6 months)