Effect of Patient Education on Treatment Adherence and Satisfaction Among Acne Patients Receiving Once-daily Epiduo Gel Treatment in Primary Care Clinics
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 97
- 试验地点
- 10
- 主要终点
- Mean Rate of Adherence, as Assessed by Medical Event Monitoring System (MEMS)
研究概览
简要总结
This is a multi-center, randomised and controlled study in subjects with acne vulgaris. The main objective of this study is to evaluate the effect of a supplementary patient education intervention (in addition to the standard-of-care patient education) on treatment adherence and satisfaction among acne patients receiving once-daily EpiduoTM gel treatment in primary care clinics.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Health Services Research
- 盲法
- None
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
- •Male or female subjects age of 12 years or older,
- •With facial acne vulgaris that can be managed in primary care
排除标准
- •Female subjects who are pregnant, nursing or planning a pregnancy during the study,
- •Subjects have a very severe variant of acne such as fulminating acne with systemic symptoms (acne fulminans)
研究组 & 干预措施
Standard of care + supplementary education
Subjects will receive supplementary patient educational material in addition to standard-of-care instructions.
干预措施: Standard of care + supplementary education (Behavioral)
Standard of care
Subjects will receive standard-of-care instructions only.
干预措施: Standard of care (Behavioral)
Standard of care + additional visits
Subjects will receive standard-of-care instructions, and two additional clinical visits.
干预措施: Standard of care + additional visits (Behavioral)
结局指标
主要结局
Mean Rate of Adherence, as Assessed by Medical Event Monitoring System (MEMS)
时间窗: week 12
To prevent bias, treatment adherence was assessed without subject's knowledge using a Medication Event Monitoring System (MEMS). The treatment was placed in a container fitted with a MEMS cap which recorded the time/date every time it was opened and/or closed. A day with at least one opening was considered a day the subject was adherent. Mean rate of adherence in % corresponds to the number of days the subject was adherent dividided by the total number of days of the study (84 days) times 100. Analysis was performed on the "worst-case" population: Missing data were considered as non-adherence.
次要结局
未报告次要终点