NCT02377557已完成不适用
Topical Steroid Registry: Observational Study to Assess Safety and Use Pattern in Korea
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,175
- 试验地点
- 1
- 主要终点
- Rate of adverse drug reaction upon use of topical steroid
研究概览
简要总结
To assess incidence of adverse drug reactions and use pattern of topical steroids among patients who are prescribed or purchase over the counter (OTC) topical steroids for skin conditions in Korea
详细描述
- Active collection of safety data, systemic and local adverse events.
- In addition to spontaneous adverse event reports, patients will be asked on occurrence of adverse events upon use of topical steroids at 1 month, 2 month, and 6 month after study enrollment by e-mail or phone call
- Causality of adverse events will be assessed by independent two professionals
- Document the utility pattern of topical steroid, misuse (inappropriate indication) or overuse (in terms of application frequency or treatment duration)
- Collection of information related with adverse event management
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
- 19 Years 至 69 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients or guardian of child purchased topical steroids in Korea
- •Informed consent to participate
- •Willing to follow and abide by the protocol
排除标准
- 未提供
结局指标
主要结局
Rate of adverse drug reaction upon use of topical steroid
时间窗: 4 week after time of enrollment
次要结局
- Rate of misuse and overuse of topical steroids(6 month after time of enrollment)
- Rate of adverse drug reaction upon use of topical steroid(6 month after time of enrollment)
- Impact of covariates on incidence of adverse drug reaction(6 month after time of enrollment)
- Rate of adverse drug reaction by potency, route of purchase (prescription/self diagnosed), drug classification (prescription only/over the counter)(1 month after time of enrollment)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
不适用
Efficacy of Targeted Intervention for Topical Steroid Phobia.Dermatologic DiseaseAdherence, MedicationPhobiaNCT03658252National University Health System, Singapore270
已完成
4 期
Reconstitution With Pimecrolimus Cream 1% of Steroid-damaged Skin in Adults With Atopic DermatitisAtopic DermatitisNCT00367393Novartis41
招募中
不适用
Awareness regarding use of topical steroids in DermatologyCTRI/2017/12/010733DJST
Unknown
4 期
Medical and Surgical Treatment for Idiopathic Granulomatous MastitisGranulomatous MastitisNCT02959580Peking Union Medical College Hospital100
已完成
不适用
Incidence of Various Types of Systemic Reactions Related to Spinal Steroid Injection: A Prospective StudyIncidence and Types of Systemic Reactions Occurring After Spinal Steroid Injection in a Large PopulationNCT01756196Seoul National University Bundang Hospital997