Glycyrrhetinic Acid and Acute Irritant Dermatitis

NCT07286487 | Recruiting

• 2 other identifiers: 2181-198-03-04-25-0072IP-UNIST-35
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Irritant Contact Dermatitis

Outcome Measures

Primary Outcomes (4)

• Transepidermal water loss

  Tewameter will be used to assess skin barrier function as a measurement of the water loss (g/m2/h).

  1st, 2nd, 3rd, 4th, 5th, 8th and 10th day of the trial

• Hydration

  Corneometer will be used to estimate skin dryness. It is a relative measurement and uses arbitrary units (AU).

  1st, 2nd, 3rd, 4th, 5th, 8th and 10th day of the trial

• Erythema

  Mexameter will be used to assess erythema. It is a relative measurement and uses arbitrary units (AU).

  1st, 2nd, 3rd, 4th, 5th, 8th and 10th day of the trial

• Skin elasticity

  Cutometer will be used to assess skin elasticity.

  1st, 2nd, 3rd, 4th, 5th, 8th and 10th day of the trial

Study Arms (10)

No Treatment and Intact skin

OTHER

No topical product will be applied. Intact skin.

Other: No Treatment

Placebo and Intact skin

PLACEBO COMPARATOR

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.

Other: Placebo

Glycyrrhetinic Acid (low-dose formulation) and Intact skin

EXPERIMENTAL

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.

Other: Low Dose Glycyrrhetinic Acid Formulation

Glycyrrhetinic Acid (high-dose formulation) and Intact skin

EXPERIMENTAL

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: High Dose Glycyrrhetinic Acid Formulation

No Treatment and Irritation

OTHER

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

Procedure: SLS induced irritation; Other: No Treatment

Placebo and Irritation

PLACEBO COMPARATOR

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.

Procedure: SLS induced irritation; Other: Placebo

Glycyrrhetinic Acid (low-dose formulation) and Irritation

EXPERIMENTAL

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.

Procedure: SLS induced irritation; Other: Low Dose Glycyrrhetinic Acid Formulation

Glycyrrhetinic Acid (high-dose formulation) and Irritation

EXPERIMENTAL

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.

Procedure: SLS induced irritation; Other: High Dose Glycyrrhetinic Acid Formulation

Glycyrrhetinic Acid (intermediate-dose formulation) and Intact skin

EXPERIMENTAL

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.

Other: Intermediate Dose Glycyrrhetinic Acid Formulation

Glycyrrhetinic Acid (intermediate-dose formulation) and Irritation

EXPERIMENTAL

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.

Procedure: SLS induced irritation; Other: Intermediate Dose Glycyrrhetinic Acid Formulation

Interventions

Low Dose Glycyrrhetinic Acid Formulation OTHER

Topical formulation containing a low concentration of 18β-glycyrrhetinic acid. Designed to assess the effects of the active compound at a low dose on skin barrier recovery and skin parameters following SLS-induced irritation. The formulation is applied daily to designated test sites on both irritated and intact forearm areas for the duration of the study.

Glycyrrhetinic Acid (low-dose formulation) and Intact skin; Glycyrrhetinic Acid (low-dose formulation) and Irritation

Intermediate Dose Glycyrrhetinic Acid Formulation OTHER

Topical formulation containing an intermediate concentration of 18β-glycyrrhetinic acid. Designed to assess the effects of the active compound at an intermediate dose on skin barrier recovery and skin parameters following SLS-induced irritation. The formulation is applied daily to designated test sites on both irritated and intact forearm areas for the duration of the study.

Glycyrrhetinic Acid (intermediate-dose formulation) and Intact skin; Glycyrrhetinic Acid (intermediate-dose formulation) and Irritation

High Dose Glycyrrhetinic Acid Formulation OTHER

Topical formulation containing a high concentration of 18β-glycyrrhetinic acid. Designed to assess the effects of the active compound at a high dose on skin barrier recovery and skin parameters following SLS-induced irritation. The formulation is applied daily to designated test sites on both irritated and intact forearm areas for the duration of the study.

Glycyrrhetinic Acid (high-dose formulation) and Intact skin; Glycyrrhetinic Acid (high-dose formulation) and Irritation

No Treatment OTHER

Designated test area with no topical application after irritation (on the irritated forearm) and on corresponding intact skin (on the non-irritated forearm). Serves as a baseline reference for spontaneous recovery and physiological skin variability.

No Treatment and Intact skin; No Treatment and Irritation

Placebo OTHER

Topical formulation identical in composition to the active preparations but without glycyrrhetinic acid. Used to evaluate the effect of the formulation vehicle on skin parameters. Applied daily to designated test sites on both irritated and intact forearm areas for the duration of the study.

Placebo and Intact skin; Placebo and Irritation

SLS induced irritation PROCEDURE

Skin irritation will be induced on 4 defined test sites on one forearm (randomly selected forearm) using 60 uL of 1% w/v sodium lauryl sulfate (SLS) aqueous solution under occlusion for a defined period to create a controlled model of acute irritant dermatitis. The contralateral forearm will remain untreated and serve as intact skin for comparison. Following the induction phase, all test products (placebo and active formulations) will be applied to both irritated and intact sites according to the treatment allocation.

Glycyrrhetinic Acid (high-dose formulation) and Irritation; Glycyrrhetinic Acid (intermediate-dose formulation) and Irritation; Glycyrrhetinic Acid (low-dose formulation) and Irritation; No Treatment and Irritation; Placebo and Irritation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Split, School of Medicine: lead
• European Union: collaborator

Study Sites (1)

University of Split School of Medicine

Split, 21000, Croatia

RECRUITING

Related Publications (5)

• Scheinman PL, Vocanson M, Thyssen JP, Johansen JD, Nixon RL, Dear K, Botto NC, Morot J, Goldminz AM. Contact dermatitis. Nat Rev Dis Primers. 2021 May 27;7(1):38. doi: 10.1038/s41572-021-00271-4.

  PMID: 34045488 BACKGROUND

• Johansen JD, Bonefeld CM, Schwensen JFB, Thyssen JP, Uter W. Novel insights into contact dermatitis. J Allergy Clin Immunol. 2022 Apr;149(4):1162-1171. doi: 10.1016/j.jaci.2022.02.002. Epub 2022 Feb 18.

  PMID: 35183605 BACKGROUND

• Kang SY, Um JY, Chung BY, Lee SY, Park JS, Kim JC, Park CW, Kim HO. Moisturizer in Patients with Inflammatory Skin Diseases. Medicina (Kaunas). 2022 Jul 1;58(7):888. doi: 10.3390/medicina58070888.

  PMID: 35888607 BACKGROUND

• Weisshaar E. Chronic Hand Eczema. Am J Clin Dermatol. 2024 Nov;25(6):909-926. doi: 10.1007/s40257-024-00890-z. Epub 2024 Sep 19.

  PMID: 39300011 BACKGROUND

• Kowalska A, Kalinowska-Lis U. 18beta-Glycyrrhetinic acid: its core biological properties and dermatological applications. Int J Cosmet Sci. 2019 Aug;41(4):325-331. doi: 10.1111/ics.12548. Epub 2019 Jun 28.

  PMID: 31166601 BACKGROUND

MeSH Terms

Conditions

Dermatitis, Irritant

Condition Hierarchy (Ancestors)

Dermatitis, Contact; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 2, 2025
• First Posted: December 16, 2025
• Study Start: September 14, 2026
• Primary Completion (Estimated): December 4, 2026
• Study Completion (Estimated): December 4, 2026
• Last Updated: September 18, 2026

Record last verified: 2025-11

Locations

CR (1)