Effects of a Berry Oil Cream on Atopic Eczema and Skin
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 83
- 试验地点
- 1
- 主要终点
- Change in severity of symptoms
研究概览
简要总结
Atopic eczema is a chronic inflammatory skin disease associated with itch and inflammatory lesions in typical skin areas. The objective of this study is to investigate the effects of a cream containing berry and plant oils and humectants on atopic eczema and dry skin.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Study has two parts. In part 1 the participants, care provider and outcome assessor know which treatment is given to each skin area. In part 2 participant, care provider, investigator and outcome assessor do not know which treatment is given to each skin area. Masking is done by identical cream tubes.
入排标准
- 年龄范围
- 12 Years 至 75 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Atopic Eczema (mild or medium severity)
排除标准
- •Other serious skin conditions (for example psoriasis)
- •Known hypersensitivity to ingredients of the study creams
- •Medication seriously affecting immune function
研究组 & 干预措施
Berry Oil Cream
Study part 1: Administered to a chosen eczema lesion on randomized body half 1-2 times/d or more frequently (use reported to study logbook) for two weeks. Also administered to forearm (randomized body half) twice/d for two weeks. Study part 2: Administered to randomized body half 1-2 times/d for five weeks.
干预措施: Berry Oil Cream (Device)
Control
Study part 1: A chosen eczema lesion on randomized body half is an untreated control for two weeks. Also one forearm (on randomized body half) is a control with no treatment for two weeks.
Reference cream
A commercial reference cream, not containing berry and plant oils. Study part 2: Administered to randomized body half 1-2 times/d for five weeks.
干预措施: Reference Cream (Other)
结局指标
主要结局
Change in severity of symptoms
时间窗: Part 1: Baseline, 2 weeks. Part 2: Baseline, 2 weeks, 5 weeks
Modified Patient Oriented Eczema Measure (POEM) questionnaire. Scale range: 0-24. Decrease indicates better outcome/ milder symptoms.
Change in skin hydration
时间窗: Part 1: Baseline, 2 weeks. Part 2: Baseline, 2 weeks, 5 weeks
Measurement of moisture (capacitance, proportional to water content of skin)
Change in sensation of itch
时间窗: Part 1: Baseline, 2 weeks. Part 2: Baseline, 2 weeks, 5 weeks
Visual Analog Scale (VAS) evaluation. Scale range 0-10. Decrease indicates better outcome/ milder symptoms.
Change in transepidermal water loss (TEWL)
时间窗: Part 1: Baseline, 2 weeks. Part 2: Baseline, 2 weeks, 5 weeks
Measurement of TEWL (g/m2h)
Change in severity of atopic eczema
时间窗: Part 1: Baseline, 2 weeks. Part 2: Baseline, 5 weeks
Objective local Scoring Atopic Dermatitis (SCORAD) index. Scale range for objective local scorad in study part 1 (chosen eczema lesion) 0-63, in study part 2 (body half) 0-73. Decrease indicates better outcome/ milder symptoms.
Change in skin pH
时间窗: Part 1: Baseline, 2 weeks. Part 2: Baseline, 2 weeks, 5 weeks
Measurement of skin pH
次要结局
- Change in symptoms of itching, dryness, flaking of skin(Part 1: Baseline, 2 weeks. Part 2: Baseline, 2 weeks, 5 weeks)
研究者
Petra Larmo
Ph.D., R&D Manager
Aromtech Ltd.