A Prospective Post Market Clinical Follow-up Investigation With Epaderm® Cream to Confirm Performance and Safety Parameters
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 121
- 试验地点
- 4
- 主要终点
- Number of Participants With Improved Skin Moisturization
研究概览
简要总结
This investigation is designed as a prospective, non-randomised, single arm clinical investigation. Data is collected from approximately 120 evaluable subjects, divided into three groups of approximately 40 subjects; infants (0-36 months old), children (3-18 years old) and adults (>18 years old), with the following indications: eczema, psoriasis and other dry skin conditions. Each subject will be followed during 4 weeks treatment, with a visit at baseline (visit 1), at 2 weeks (visit 2) and at 4 weeks (visit 3) treatment.
详细描述
Primary Endpoint Skin hydration after treatment with Epaderm Cream up to 4 weeks, evaluated by the subject using a questionnaire.
Secondary Endpoints
- Skin hydration after treatment with Epaderm Cream up to 4 weeks, evaluated by investigator/nurse using a questionnaire.
- Skin hydration after treatment with Epaderm Cream up to 4 weeks, using a non-invasive device MoistureMeterEpiD.
- Investigator/nurse evaluation of skin softness after 2 and 4 weeks treatment, using a questionnaire.
- Subject evaluation of skin softness after 2 and 4 weeks treatment, using a questionnaire.
- Investigator/nurse evaluation regarding:
- Clinical signs/conditions of the affected skin and changes thereof
- Did the product prolong the relapse period for flares?
- Subject evaluation regarding:
- Did you use Epaderm Cream according to prescription?
- Comfort during treatment
- Time of onset of effect
- Did the product have the expected effect
- Overall impression
- Was the investigational device used as a skin cleanser?
- Concomitant and previous medication and treatment
- Number of Adverse Device Effects (ADEs) related to the use of Epaderm Cream during the investigation
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 4 Weeks 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects suitable for treatment with Epaderm Cream, as deemed by the investigator and according to intended use (eczema, psoriasis and other dry skin conditions).
- •Subject or subject's legal representative must be able to read and sign the Patient Information and Consent Form.
排除标准
- •Known allergy/hypersensitivity to any of the components of Epaderm Cream.
- •Subject not suitable for the investigation according to the investigator's judgement.
- •Subject participating in other ongoing similar clinical studies or other clinical studies which could interfere with this investigation, as judged by the investigator.
- •Subject previously enrolled in the current clinical investigation.
结局指标
主要结局
Number of Participants With Improved Skin Moisturization
时间窗: Assessed at 2 weeks and 4 weeks visit, 4 weeks visit reported
Participants were considered to have improved moisturization if they responded strongly agree or agree on the questionnaire. Evaluations were carried out in the same affected spot from a scale of Strongly agree, Agree, Neither agree nor disagree, Disagree, Strongly disagree where Strongly agree is the most improved skin moisturization:
次要结局
- Number of Participants With Adverse Device Effects (ADEs)(Evaluated at every follow-up visit (2 weeks and 4 weeks visit))
- Number of Participants With Improved Skin Softness(Assessed at 2 weeks and 4 weeks visit, 4 weeks visit reported)
- Number of Participants Who Used Epaderm as a Skin Cleanser(Assessed at 2 weeks and 4 weeks visit, 4 weeks visit reported where participates answered 'yes'.)
- Number of Participants Who Confirmed Overall Effect and Comfort of Treatment(Assessed at 2 weeks and 4 weeks visit, 4 weeks visit reported)
- Number of Participants Who Reported Applying Epaderm Cream Twice a Day(Assessed at 2 weeks and 4 weeks visit, 4 weeks visit reported)
- Number of Participants With Improved Overall Dry Skin/Xerosis(Assessed at 2 weeks and 4 weeks visit, 4 weeks visit reported)
- Number of Participants With Improvement of Skin Moisturization By Week 4(Assessed at 2 weeks and 4 weeks visit. Improvement within 4 weeks visit reported.)