Glycyrrhetinic Acid and Acute Irritant Dermatitis

University of Split

Status: Not yet enrolling

Conditions: Irritant Contact Dermatitis

Treatments: Other: Higher Dose Glycyrrhetinic Acid; Procedure: SLS induced irritation; Other: Lower Dose Glycyrrhetinic Acid; Other: No Treatment; Other: Placebo

Study type: Interventional

Funder types: Other

Identifiers

NCT07286487

2181-198-03-04-25-0072

IP-UNIST-35 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 30 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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.

Exclusion criteria

• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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30 participants in 8 patient groups, including a placebo group

No Treatment and Intact skin

Other group

Description:

No topical product will be applied. Intact skin.

Treatment:

Other: No Treatment

Placebo and Intact skin

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo

Glycyrrhetinic Acid (lower dose) and Intact skin

Experimental group

Description:

Topical formulation containing a lower concentration of 18β-glycyrrhetinic acid. Designed to evaluate the dose-dependent effect of the active compound on intact skin parameters. Intact skin.

Treatment:

Other: Lower Dose Glycyrrhetinic Acid

Glycyrrhetinic Acid (higher dose) and Intact skin

Experimental group

Description:

Topical formulation containing a higher concentration of 18β-glycyrrhetinic acid. Used to assess whether a higher dose enhances anti-inflammatory and barrier-restoring effects compared with the lower dose and placebo.

Treatment:

Other: Higher Dose Glycyrrhetinic Acid

No Treatment and Irritation

Other group

Description:

No topical product will be applied. SLS induced skin irritation.

Treatment:

Other: No Treatment

Procedure: SLS induced irritation

Placebo and Irritation

Placebo Comparator group

Description:

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.

Treatment:

Other: Placebo

Procedure: SLS induced irritation

Glycyrrhetinic Acid (lower dose) and Irritation

Experimental group

Description:

Topical formulation containing a lower concentration of 18β-glycyrrhetinic acid. Designed to evaluate the dose-dependent effect of the active compound on skin recovery and barrier function after irritation. SLS induced skin irritation.

Treatment:

Other: Lower Dose Glycyrrhetinic Acid

Procedure: SLS induced irritation

Glycyrrhetinic Acid (higher dose) and Irritation

Experimental group

Description:

Topical formulation containing a higher concentration of 18β-glycyrrhetinic acid. Used to assess whether a higher dose enhances anti-inflammatory and barrier-restoring effects compared with the lower dose and placebo. SLS induced skin irritation

Treatment:

Procedure: SLS induced irritation

Other: Higher Dose Glycyrrhetinic Acid