Retrospective Study to Evaluate the Safety of Sebryl® and / or Sebryl Plus® in the Treatment of Seborrheic Dermatitis and Psoriasis of the Scalp in Routine Medical Practice.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Classify adverse events
研究概览
简要总结
Observational, descriptive, retrospective, multicenter study to evaluate the safety of the treatment with Sebryl® and / or Sebryl Plus® in the management of seborrheic dermatitis and psoriasis of the scalp in routine medical practice.
详细描述
The objective of this study is to evaluate the frequency and intensity of adverse events presented during treatment with Sebryl® and / or Sebryl Plus® for the management of seborrheic dermatitis and psoriasis of the scalp. The sample will be at convenience. The files of the patients who have received treatment with Sebryl® and / or Sebryl Plus® in the last 5 years (2016 to 2021) will be chosen.
The researchers or the personnel designated by them will capture the information recorded by the treating physicians in the clinical file, sociodemographic, clinical and safety data that were presented after the prescription of Sebryl® and / or Sebryl Plus®.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Retrospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Treatment with Sebryl® and / or Sebryl Plus® documented, for at least 2 consultations.
- •That the patient has been questioned about possible adverse events
排除标准
- •That the patient has used some other concomitant treatment for seborrheic dermatitis and psoriasis on the scalp.
结局指标
主要结局
Classify adverse events
时间窗: Last 5 years
Classify reported adverse events according to seriousness, severity (intensity) and causality of the clinical manifestation
Describe study population by gender ratio
时间窗: Last 5 years
Describe the proportion of women and men included in the study
Proportion of adverse events
时间窗: Last 5 years
Evaluate the presence or absence of adverse events reported in the clinical files.
Mean age in years
时间窗: Last 5 years
Describe the mean age in years of the patients included in the study.
Describe the body mass index through weight and heigh
时间窗: Last 5 years
Describe the body mass index of the study population calculated through weight and heigh of the patient and using the formula kilogram over square meter.
Mean heart rate in beats per minute
时间窗: Last 5 years
Describe the mean heart rate in beats per minute of the patients included in the study.
Describe the blood pressure millimetres of mercury (mmHg)
时间窗: Last 5 years
Describe the blood pressure in mmHg of the patients included in the study.
Percentage of times use outside of expected indications
时间窗: Last 5 years
Percentage of times Sebryl® and / or Sebryl® Plus were used outside of expected indications.
次要结局
- Description of usage pattern according to prescribed time(Last 5 years)
- Description of usage pattern according to prescribed dosage(Last 5 years)