A Multicentre, Prospective and Registry Study to Explore the Efficacy and Safety of Mucopolysaccharide Polysulfate Cream in the Treatment of Patients With Eczema
试验速览
- 阶段
- 不适用
- 入组人数
- 1,800
- 试验地点
- 1
- 主要终点
- EASI score
研究概览
简要总结
The study was designed to collect information over 1800 patients with a clinical diagnosis of subacute or chronic eczema, these patients' prescriptions contain Hirudoid®. EASI, IGA and more indicators are evaluated. Data were collected for a maximum of 12 weeks according to the clinician's consultation and follow-up (Time points were set at baseline, 1, 2, 3, 4, 8 and 12 weekends). The above data were analysed to explore the optimal treatment modality, dose and treatment period for patients with subacute or chronic eczema.
详细描述
The study was designed to collect information over 1800 patients with a clinical diagnosis of subacute or chronic eczema, these patients' prescriptions contain Hirudoid® (Hirudoid® alone or in combination with glucocorticoids). Basic demographic information (age, sex, height, weight, lifestyle, occupation), vital signs (blood pressure, heart rate, temperature, etc.), past medical and treatment history, eczema area and severity index (EASI) scores and corresponding symptom scores, Dermatology Life Quality Index (DLQI) score, Investigator's global assessment (IGA) of disease severity score, Visual analogue scale (VAS) with subject's pruritus, photographs of the eczema area and recurrence rate were collected. Data were evaluated for a maximum of 12 weeks according to the clinician's consultation and follow-up (Time points were set at baseline, 1, 2, 3, 4, 8 and 12 weekends). The above data were analysed to explore the optimal treatment modality, dose and treatment period for patients with subacute or chronic eczema.
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
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18-75 years of age, male or female;.
- •Patients with a clinical diagnosis of subacute or chronic eczema and whose prescription contains Hirudoid®.
- •Subjects fully understand the content of this study, sign informed consent.
排除标准
- •Hypersensitivity to any of the ingredients of this product.
- •Patients with heparin hypersensitivity, bleeding-prone constitution and known heparin-induced thrombocytopenia.
- •Open wounds and broken skin and mucous membranes
- •Patients with localized combined bacterial, viral and fungal infections.
- •Pregnant or lactating women or those who are unable to use contraception during the study period
- •Those with psychiatric disorders, poor compliance and unable to complete the study.
- •Any other reason that the investigator considers inappropriate for inclusion.
研究组 & 干预措施
Mucopolysaccharide Polysulfate Cream
Prescribed only for patients with Mucopolysaccharide Polysulfate Cream.
干预措施: Mucopolysaccharide Polysulfate Cream (Drug)
Mucopolysaccharide Polysulfate Cream and glucocorticoids
Patients whose prescriptions contain Mucopolysaccharide Polysulfate Cream and glucocorticoids (Combination therapy, but not always).
干预措施: Mucopolysaccharide Polysulfate Cream and glucocorticoids (Drug)
结局指标
主要结局
EASI score
时间窗: It could be any time point in the weekend of 1, 2, 3, 4, 8 and 12
The greatest change in EASI score occurred during the 12 weeks (follow up point were set at baseline, 1, 2, 3, 4, 8 and 12 weekends) after dosing compared to baseline.
次要结局
- Clinical manifestations. Including Erythema, Thickness (induration, papulation, swelling), Scratching (excoriation), Lichenification (lined skin, furrowing, prurigo nodules).(Baseline, 1, 2, 3, 4, 8 and 12 weekends)
- Recurrence rate.(8 and 12 weekends)
- Dermatology Life Quality Index (DLQI) score.(Baseline, 1, 2, 3, 4, 8 and 12 weekends)
- Adverse event(1, 2, 3, 4, 8 and 12 weekends)
- Visual analogue scale (VAS) score(Baseline, 1, 2, 3, 4, 8 and 12 weekends)
- The investigator's global assessment (IGA) score(Baseline, 1, 2, 3, 4, 8 and 12 weekends)