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NCT Number: NCT07286487

Glycyrrhetinic Acid and Acute Irritant Dermatitis

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.

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Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Split School of Medicine

Split, 21000, Croatia

Location contact

Dario Leskur, asst. prof., MPharm, PhD

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

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.

Lower Dose Glycyrrhetinic Acid

Other

Topical formulation containing a lower concentration of 18β-glycyrrhetinic acid.

Designed to assess the effects of the active compound at a lower dose on skin barrier recovery and skin parameters following SLS-induced irritation.

Applied daily to designated test sites on both irritated and intact forearm areas for the duration of the study.

Higher Dose Glycyrrhetinic Acid

Other

Topical formulation containing a higher concentration of 18β-glycyrrhetinic acid.

Designed to assess the effects of the active compound at a lower dose on skin barrier recovery and skin parameters following SLS-induced irritation.

Applied daily to designated test sites on both irritated and intact forearm areas for the duration of the study.

Primary outcomes

  1. Transepidermal water loss

    Time frame: 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).

  2. Hydration

    Time frame: 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).

  3. Erythema

    Time frame: 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).

  4. Skin elasticity

    Time frame: Baseline, Irritation Assessment, 3rd, 6th, 8th and 10th day of the treatment

    Cutometer will be used to assess skin elasticity.

Sponsors and collaborators

Lead sponsor

University of Split, School of Medicine

Other

Collaborators

  • European Union

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2027
First posted
Dec 16, 2025
Registry last updated
Feb 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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