Contact Dermatitis Clinical Trials

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Effects of Glycyrrhetinic Acid on Human Skin in an Acute Irritant Contact Dermatitis Model

Status: Recruiting
Location: See location...
Intervention Type: Other, Procedure
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: t
View:

• 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.

Locations
Other Locations
Croatia
University of Split School of Medicine
RECRUITING
Split
Time Frame
Start Date: 2026-09-14
Estimated Completion Date: 2026-12-04
Participants
Target number of participants: 30
Treatments
Other: No Treatment and Intact skin
No topical product will be applied. Intact skin.
Placebo_comparator: 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.
Experimental: 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.
Experimental: 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.
Other: No Treatment and Irritation
No topical product will be applied. SLS induced skin irritation.
Placebo_comparator: 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.
Experimental: 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.
Experimental: 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.
Experimental: 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.
Experimental: 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.
Sponsors
Collaborators: European Union
Leads: University of Split, School of Medicine

This content was sourced from clinicaltrials.gov