The Effectiveness of a Topical Palmitoylethanolamide Formulation (Levagen+) for Reducing the Symptoms of Eczema Versus a Comparator
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Eczema area and severity index (SA-EASI)
研究概览
简要总结
This is a double blind, randomised, non-clinical study with 2 groups (1 investigational group and 1 comparator group) aiming to assess the effectiveness of PEA for reducing eczema severity compared to a base comparator moisturiser in healthy adults aged over 18 years.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults (over 18)
- •Suffering from atopic eczema with symptoms of redness, dry skin, scaling and/or itchiness on hands or arms
- •Otherwise healthy
- •Able to provide informed consent
排除标准
- •Active allergic skin responses
- •Unstable or serious illness (eg kidney, liver, GIT, heart conditions, diabetes, mood disorders, cancer)
- •Use of immunosuppressive medication within the last 3 months
- •Pregnant or lactating women
- •Chronic past and/or current alcohol use (>14 alcoholic drinks week)
- •Allergic to any of the ingredients in active or comparator formula
- •An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.
研究组 & 干预措施
1.5% Palmitoylethanolamide (PEA) sold as Levagen+
Investigational product will be provided as a topical cream containing 1.5% PEA and participants will be asked to apply to their affected site 2 times daily for 4 weeks. Cream should be applied liberally (as you would a moisturiser cream) such to coat the affected area and absorb into the skin.
干预措施: 1.5% Palmitoylethanolamide (PEA) sold as Levagen+ (Drug)
Placebo comparator
A comparator placebo moisturiser cream (an unscented moisturizing base cream) will be provided and applied in the same manner as the active ingredient group. Participants will be asked to apply to their affected site 2 times daily for 4 weeks. Cream should be applied liberally (as you would a moisturiser cream) such to coat the affected area and absorb into the skin.
干预措施: Placebo Comparator (Drug)
结局指标
主要结局
Eczema area and severity index (SA-EASI)
时间窗: Baseline prior to commencement, Week 2 and Week 4
Change in eczema area and severity index (SA-EASI)
次要结局
- Change in Quality of Life (DQOL)(Baseline prior to commencement, Week 2 and Week 4)
- Change in topical anti-inflammatory use(Baseline prior to commencement, Week 2 and Week 4)
- Patient eczema self assessment (Patient Orientated Eczema Measure)(Baseline prior to commencement, Week 2 and Week 4)
- Change in itchiness (pruritus numerical rating scale)(Baseline prior to commencement, Week 2 and Week 4)