Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
30 participants
INTERVENTIONAL
2026-01-01
2026-09-25
Brief Summary
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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.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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No Treatment and Intact skin
No topical product will be applied. Intact skin.
No Treatment
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 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.
Placebo
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.
Glycyrrhetinic Acid (lower dose) and Intact skin
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.
Lower Dose Glycyrrhetinic Acid
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.
Glycyrrhetinic Acid (higher dose) and Intact skin
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.
Higher Dose Glycyrrhetinic Acid
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.
No Treatment and Irritation
No topical product will be applied. SLS induced skin irritation.
SLS induced irritation
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
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 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.
SLS induced irritation
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.
Placebo
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.
Glycyrrhetinic Acid (lower dose) and Irritation
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.
SLS induced irritation
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.
Lower Dose Glycyrrhetinic Acid
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.
Glycyrrhetinic Acid (higher dose) and Irritation
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
SLS induced irritation
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.
Higher Dose Glycyrrhetinic Acid
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.
Interventions
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SLS induced irritation
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
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
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
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
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* Non-compliance with the study protocol.
* Voluntary withdrawal or personal decision not to continue participation.
18 Years
ALL
Yes
Sponsors
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University of Split, School of Medicine
OTHER
Responsible Party
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Locations
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University of Split School of Medicine
Split, , Croatia
Countries
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References
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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.
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.
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.
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.
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.
Other Identifiers
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2181-198-03-04-25-0072
Identifier Type: -
Identifier Source: org_study_id