Assessment of the Effect of Helichrysum Italicum Extract in Irritant Contact Dermatitis: A Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in Transepidermal Water Loss (TEWL)
研究概览
简要总结
The goal of this clinical trial is to evaluate the efficacy and safety of a topical cream containing Immortelle (Helichrysum italicum) extract in promoting skin barrier recovery and reducing signs of irritant contact dermatitis in healthy adult participants.
The main questions it aims to answer are:
- Does topical application of Helichrysum italicum extract improve skin barrier recovery following experimentally induced irritant contact dermatitis?
- Does the cream containing Helichrysum italicum extract reduce transepidermal water loss and erythema, and improve skin hydration compared to a standard moisturizing cream?
- Is the topical application of Helichrysum italicum extract safe and well tolerated?
Researchers will compare skin sites treated with a cream containing Helichrysum italicum extract, placebo-treated skin sites, and untreated skin sites to determine whether the addition of the extract provides additional benefits in skin barrier recovery.
Participants will:
- Undergo induction of irritant contact dermatitis using sodium lauryl sulfate (SLS) under occlusion.
- Apply a cream containing Helichrysum italicum extract to one designated skin site and a placebo cream to another designated skin site twice daily throughout the study period.
- Have an additional SLS-treated skin site left untreated to assess natural skin barrier recovery.
- Apply the cream containing Helichrysum italicum extract to a separate area of healthy, intact skin.
- Attend daily study visits for non-invasive assessments of skin barrier function, including transepidermal water loss, skin hydration, and erythema measurements.
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, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 50 Years(Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •healthy volunteers who gave written informed consent
排除标准
- •skin disease
- •skin damage on measurement sites
- •use of corticosteroids, antihistamines and immunomodulators a month prior the inclusion and during the trial
- •pregnancy or breastfeeding
- •immunosuppression
- •allergic or irritant reactions to the constituents of the cream
研究组 & 干预措施
Placebo Cream
Participants will receive the same emollient cream base without Helichrysum italicum extract applied to an SLS-treated skin site.
干预措施: Placebo Cream (Other)
Untreated Control Site
An SLS-treated skin site that will not receive any topical treatment and will serve as a control for natural skin barrier recovery.
Helichrysum italicum Extract Cream
Participants will receive a topical emollient cream containing Helichrysum italicum extract applied to an SLS-treated skin site.
干预措施: Helichrysum italicum Extract Cream (Other)
结局指标
主要结局
Change in Transepidermal Water Loss (TEWL)
时间窗: Baseline (prior to SLS application) and Days 1, 2, 3, 4, and 7 (change from baseline).
Skin barrier function will be assessed by measuring transepidermal water loss using a Tewameter TM 300 probe. Values will be expressed in g/m²/h
Change in Skin Hydration
时间窗: Baseline (prior to SLS application) and Days 1, 2, 3, 4, and 7 (change from baseline).
Hydration of the stratum corneum will be assessed using a Corneometer CM 825 probe.
Change in Skin Erythema
时间窗: Baseline (prior to SLS application) and Days 1, 2, 3, 4, and 7 (change from baseline).
Skin erythema will be assessed using a Mexameter MX 18 probe.
次要结局
未报告次要终点
