Effects of Glycyrrhetinic Acid on Human Skin in an Acute Irritant Contact Dermatitis Model
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
- 2
- 主要终点
- Transepidermal water loss
研究概览
简要总结
Irritant dermatitis is one of the most common inflammatory skin disorders, caused by exposure to external substances that induce inflammation and immune activation. Standard management includes avoidance of irritants, restoration of the skin barrier using emollients, and the application of anti-inflammatory drugs such as topical corticosteroids. However, due to the risks associated with long-term corticosteroid use, there is an interest in developing emollient formulations enriched with bioactive compounds possessing anti-inflammatory properties. Among those promising compounds is glycyrrhetinic acid.
18β-Glycyrrhetinic acid, a bioactive component of licorice root extract, exhibits potent anti-inflammatory and antioxidant effects. Topical application has demonstrated beneficial outcomes in conditions such as atopic dermatitis, acne, pruritus, and UVB-induced skin damage. Its proposed mechanisms of action include inhibition of key inflammatory enzymes (COX, 5-LOX, iNOS) and promotion of skin regeneration through stimulation of aquaporin-3 expression and enhancement of epidermal turnover.
Topical application of formulations containing 18β-glycyrrhetinic acid will improve skin parameter disturbances caused by irritation induced with sodium lauryl sulfate.
This study aims to evaluate the effects of 18β-glycyrrhetinic acid on human skin parameters in an acute irritant dermatitis model induced by sodium lauryl sulfate, providing further insight into its potential role as an anti-inflammatory and barrier-restoring agent.
Funding:
Funded by the European Union - NextGenerationEU. Views and opinions expressed are however those of the author(s) only and do not necessarily reflect those of the European Union or the European Commission. Neither the European Union nor the European Commission can be held responsible for them.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy adult participants aged 18 years or older, of any sex.
- •Intact, healthy skin at the test sites.
- •No use of systemic or topical corticosteroids, immunomodulators, or antihistamines within the previous three months.
- •No use of topical emollients on the test sites within the previous seven days.
排除标准
- •Pregnant women, women suspected of being pregnant, and breastfeeding women.
- •Non-compliance with the study protocol.
- •Voluntary withdrawal or personal decision not to continue participation.
研究组 & 干预措施
Placebo and Intact skin
Topical placebo formulation identical in appearance and vehicle composition to the active preparation but without glycyrrhetinic acid. Used to control for vehicle effects on skin parameters. Intact skin.
干预措施: Placebo (Other)
No Treatment and Intact skin
No topical product will be applied. Intact skin.
干预措施: No Treatment (Other)
No Treatment and Irritation
No topical product will be applied. SLS induced skin irritation.
干预措施: No Treatment (Other)
Glycyrrhetinic Acid (high-dose formulation) and Irritation
Topical formulation containing a high concentration of 18β-glycyrrhetinic acid. Used to assess the effects of a high dose on anti-inflammatory and skin barrier-restoring outcomes following SLS-induced skin irritation, and to evaluate potential dose-dependent effects compared with the low- and intermediate-dose formulations and placebo. Applied to SLS-irritated skin.
干预措施: High Dose Glycyrrhetinic Acid Formulation (Other)
Glycyrrhetinic Acid (intermediate-dose formulation) and Intact skin
Topical formulation containing an intermediate concentration of 18β-glycyrrhetinic acid. Designed to evaluate the effects of different doses of the active compound on intact skin parameters. Applied to intact skin.
干预措施: Intermediate Dose Glycyrrhetinic Acid Formulation (Other)
Glycyrrhetinic Acid (intermediate-dose formulation) and Irritation
Topical formulation containing an intermediate concentration of 18β-glycyrrhetinic acid. Used to assess the effects of an intermediate dose on anti-inflammatory and skin barrier-restoring outcomes following SLS-induced skin irritation, and to evaluate potential dose-dependent effects compared with the low- and high-dose formulations and placebo. Applied to SLS-irritated skin.
干预措施: SLS induced irritation (Procedure)
No Treatment and Irritation
No topical product will be applied. SLS induced skin irritation.
干预措施: SLS induced irritation (Procedure)
Placebo and Irritation
Topical placebo formulation identical in appearance and vehicle composition to the active preparation but without glycyrrhetinic acid. Used to control for vehicle effects on skin parameters. SLS induced skin irritation.
干预措施: SLS induced irritation (Procedure)
Placebo and Irritation
Topical placebo formulation identical in appearance and vehicle composition to the active preparation but without glycyrrhetinic acid. Used to control for vehicle effects on skin parameters. SLS induced skin irritation.
干预措施: Placebo (Other)
Glycyrrhetinic Acid (low-dose formulation) and Intact skin
Topical formulation containing a low concentration of 18β-glycyrrhetinic acid. Designed to evaluate the effects of different doses of the active compound on intact skin parameters. Applied to intact skin.
干预措施: Low Dose Glycyrrhetinic Acid Formulation (Other)
Glycyrrhetinic Acid (high-dose formulation) and Intact skin
Topical formulation containing a high concentration of 18β-glycyrrhetinic acid. Designed to evaluate the dose-dependent effects of the active compound on intact skin parameters. Applied to intact skin.
干预措施: High Dose Glycyrrhetinic Acid Formulation (Other)
Glycyrrhetinic Acid (low-dose formulation) and Irritation
Topical formulation containing a low concentration of 18β-glycyrrhetinic acid. Used to assess the effects of a low dose on anti-inflammatory and skin barrier-restoring outcomes following SLS-induced skin irritation, and to evaluate potential dose-dependent effects compared with the intermediate- and high-dose formulations and placebo. Applied to SLS-irritated skin.
干预措施: SLS induced irritation (Procedure)
Glycyrrhetinic Acid (low-dose formulation) and Irritation
Topical formulation containing a low concentration of 18β-glycyrrhetinic acid. Used to assess the effects of a low dose on anti-inflammatory and skin barrier-restoring outcomes following SLS-induced skin irritation, and to evaluate potential dose-dependent effects compared with the intermediate- and high-dose formulations and placebo. Applied to SLS-irritated skin.
干预措施: Low Dose Glycyrrhetinic Acid Formulation (Other)
Glycyrrhetinic Acid (high-dose formulation) and Irritation
Topical formulation containing a high concentration of 18β-glycyrrhetinic acid. Used to assess the effects of a high dose on anti-inflammatory and skin barrier-restoring outcomes following SLS-induced skin irritation, and to evaluate potential dose-dependent effects compared with the low- and intermediate-dose formulations and placebo. Applied to SLS-irritated skin.
干预措施: SLS induced irritation (Procedure)
Glycyrrhetinic Acid (intermediate-dose formulation) and Irritation
Topical formulation containing an intermediate concentration of 18β-glycyrrhetinic acid. Used to assess the effects of an intermediate dose on anti-inflammatory and skin barrier-restoring outcomes following SLS-induced skin irritation, and to evaluate potential dose-dependent effects compared with the low- and high-dose formulations and placebo. Applied to SLS-irritated skin.
干预措施: Intermediate Dose Glycyrrhetinic Acid Formulation (Other)
结局指标
主要结局
Transepidermal water loss
时间窗: 1st, 2nd, 3rd, 4th, 5th, 8th and 10th day of the trial
Tewameter will be used to assess skin barrier function as a measurement of the water loss (g/m2/h).
Hydration
时间窗: 1st, 2nd, 3rd, 4th, 5th, 8th and 10th day of the trial
Corneometer will be used to estimate skin dryness. It is a relative measurement and uses arbitrary units (AU).
Erythema
时间窗: 1st, 2nd, 3rd, 4th, 5th, 8th and 10th day of the trial
Mexameter will be used to assess erythema. It is a relative measurement and uses arbitrary units (AU).
Skin elasticity
时间窗: 1st, 2nd, 3rd, 4th, 5th, 8th and 10th day of the trial
Cutometer will be used to assess skin elasticity.
Transepidermal water loss
时间窗: Baseline, Irritation Assessment, 3rd, 6th, 8th and 10th day of the treatment
Tewameter will be used to assess skin barrier function as a measurement of the water loss (g/m2/h).
Hydration
时间窗: Baseline, Irritation Assessment, 3rd, 6th, 8th and 10th day of the treatment
Corneometer will be used to estimate skin dryness. It is a relative measurement and uses arbitrary units (AU).
Erythema
时间窗: Baseline, Irritation Assessment, 3rd, 6th, 8th and 10th day of the treatment
Mexameter will be used to assess erythema. It is a relative measurement and uses arbitrary units (AU).
Skin elasticity
时间窗: Baseline, Irritation Assessment, 3rd, 6th, 8th and 10th day of the treatment
Cutometer will be used to assess skin elasticity.
次要结局
未报告次要终点