An Observational Study Investigating the Treatment Satisfaction of Atopic Dermatitis Patients Who Have Switched to Ointment (W/O Emulsion) Formulation of Very Strong Class Topical Corticosteroids
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- LEO Pharma
- 入组人数
- 55
- 主要终点
- Treatment satisfaction measured by Treatment Satisfaction Questionnaire for Medication (TSQM-9)
研究概览
简要总结
This study intends to investigate patient satisfaction of treatment with Ointment (W/O emulsion) formulations of Potency Class II topical corticosteroids (TCs) for atopic dermatitis (AD) patients in Japan. Objectives include measuring patient satisfaction, treatment adherence, itchiness, and AD severity scores.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Female and male patients with a diagnosis of atopic dermatitis who are treated with Fatty Ointment Potency Class II (Very strong class) TCs
- •Patients who are scheduled to change the formulation of the Potency Class II TC from Fatty Ointment to Ointment (Water in Oil; Water per Oil emulsion) as per investigator's routine treatment practice
- •Patients who are aged over 20
- •Patients who are able to understand and sign a written informed consent
排除标准
- •Patients participating in an investigational program with interventions outside of routine clinical practice
- •Patients with any contraindication to TCs
- •Patients who are regarded as ineligible by the investigator
- •Patients who are pregnant or breastfeeding
- •For Period 2 (Spring-Summer), patients enrolled in the Period 1
研究组 & 干预措施
Diflucortolone valerate (Nerisona/Texmeten)
Adult patients with atopic dermatitis switching from diflucortolone-valerate fatty ointment to ointment (water/oil emulsion) during autumn/ winter (Nov to Feb) or spring/ summer (May to Aug)
干预措施: Diflucortolone valerate (Nerisona) (Drug)
Diflucortolone valerate (Nerisona/Texmeten)
Adult patients with atopic dermatitis switching from diflucortolone-valerate fatty ointment to ointment (water/oil emulsion) during autumn/ winter (Nov to Feb) or spring/ summer (May to Aug)
干预措施: Diflucortolone valerate (Texmeten) (Drug)
结局指标
主要结局
Treatment satisfaction measured by Treatment Satisfaction Questionnaire for Medication (TSQM-9)
时间窗: 10 months
A Patient Reported Outcome questionnaire assessing treatment satisfaction by recalling the last 2-3 weeks of treatment
次要结局
- Eczema Area and Severity Index (EASI)(10 months)
- Treatment adherence measured by Morisky Medication Adherence Scale (MMAS-8-Item)(10 months)
- Itchiness according to Visual Analogue Scale (VAS)(10 months)
- Severity Scoring of Atopic Dermatitis (SCORAD)(10 months)