ISRCTN84958399终止未知
APOLO: AtoPic dermatitis - a crOss sectionaL study on disease characteristics and impact On patients
Pfizer (Netherlands)0 个研究点目标入组 150 人开始时间: 2021年10月11日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 终止
- 发起方
- 入组人数
- 150
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Observational
入排标准
- 性别
- All
入选标准
- •1. =12 years of age (12-15 and =16 years of age)
- •2. Clinical diagnosis of atopic dermatitis (AD)
- •3. Severity of AD classified as moderate to severe as per the selected Investigator Global Assessment (IGA) scale (Validated Investigator’s Global Assessment (vIGA-AD): vIGA-AD =3). Grade 3 is defined as clearly perceptible erythema (dull red), clearly perceptible induration/papulation, and/or clearly perceptible lichenification. Oozing and crusting may be present. [Simpson 2020]
- •4. Evidence of a personally signed and dated informed consent (assent) document indicating that the patient (or a legally acceptable representative) has been informed of and consented (assented where applicable) to all pertinent aspects of the study. Parents (or a legally acceptable representative) will sign the consent form for patients <18 years of age
- •5. Seeking medical attention for AD to the clinic for the first time (no previous visit for AD), including:
- •5.1. New M2S AD patients who present themselves for the first time at the center of reference
- •5.2. Known M2S AD patients who haven’t been in regular follow-up for at least 2 years
- •5.3. Patient referred within the center who fulfils the above criteria
排除标准
- •1. Current participation in interventional clinical study
- •2. Other active concurrent dermatological conditions which may confound correct diagnosis or symptom scores (i.e., psoriasis, chronic urticaria)
- •3. Children <12 years of age or mild severity of AD as per vIGA-AD (vIGA-AD equal or less than 2, where 2 is mild erythema, and mild papulation/infiltration)
研究者
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