An interventional study of SLS induced irritation and No Treatment in Irritant Contact Dermatitis, sponsored by University of Split, School of Medicine. Recruiting at 1 site in Croatia. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-18.
Sponsored by University of Split, School of Medicine · Not applicable, Interventional, and Treatment
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.
University of Split, School of Medicine is the lead sponsor of 51 studies on the registry; 17 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
No topical product will be applied. Intact skin.
Other: No Treatment
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
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
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 topical product will be applied. SLS induced skin irritation.
Procedure: SLS induced irritation · Other: No Treatment
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
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
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
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
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
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.
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.
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.
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.
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.
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.
Transepidermal water loss
Tewameter will be used to assess skin barrier function as a measurement of the water loss (g/m2/h).
Time frame: 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).
Time frame: 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).
Time frame: 1st, 2nd, 3rd, 4th, 5th, 8th and 10th day of the trial
Skin elasticity
Cutometer will be used to assess skin elasticity.
Time frame: 1st, 2nd, 3rd, 4th, 5th, 8th and 10th day of the trial
Plan to share: Undecided
Started Sep 2026 (actual). Primary completion is estimated for Dec 2026, 2 months after the start.
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Dermatitis, Irritant
University of Split, School of Medicine