Irritant Contact DermatitisNCT07286487
Glycyrrhetinic Acid and Acute Irritant Dermatitis
A study testing SLS induced irritation, No Treatment and Low Dose Glycyrrhetinic Acid Formulation in people with Irritant Contact Dermatitis, run by University of Split, School of Medicine at 1 site in Croatia.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Irritant Contact Dermatitis
- What is being tested?
- SLS induced irritation, No Treatment and Low Dose Glycyrrhetinic Acid Formulation
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 30 participants
- Where
- 1 siteCroatia
- Study dates
- 14 Sep 2026to 4 Dec 2026
- Phase
- Interventional
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Croatia1 site, 1 recruiting
- Recruiting
University of Split School of Medicine
Split, 21000
Dario Leskur, +38521557868, dleskur@mefst.hr
Dario Leskur, asst. prof., MPharm, PhD
About this study
Official title: Effects of Glycyrrhetinic Acid on Human Skin in an Acute Irritant Contact Dermatitis Model
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.
Read more
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
- Being tested
- SLS induced irritation, No Treatment, Placebo, Low Dose Glycyrrhetinic Acid Formulation, High Dose Glycyrrhetinic Acid Formulation
- Medical subject headings
- Dermatitis, Irritant
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SLS induced irritationProcedure or surgery
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 TreatmentOther
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.
PlaceboOther
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.
Low Dose Glycyrrhetinic Acid FormulationOther
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.
High Dose Glycyrrhetinic Acid FormulationOther
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.
Intermediate Dose Glycyrrhetinic Acid FormulationOther
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.
| Study group | Role | What they receive |
|---|---|---|
| No Treatment and Intact skin | Other | No topical product will be applied. Intact skin. Receives: 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. Receives: 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. Receives: 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. Receives: Other: High Dose Glycyrrhetinic Acid Formulation |
| No Treatment and Irritation | Other | No topical product will be applied. SLS induced skin irritation. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Procedure: SLS induced irritation; Other: Intermediate Dose Glycyrrhetinic Acid Formulation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Transepidermal water loss
Tewameter will be used to assess skin barrier function as a measurement of the water loss (g/m2/h).
Measured: 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).
Measured: 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).
Measured: 1st, 2nd, 3rd, 4th, 5th, 8th and 10th day of the trial
Skin elasticity
Cutometer will be used to assess skin elasticity.
Measured: 1st, 2nd, 3rd, 4th, 5th, 8th and 10th day of the trial
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start14 Sep 2026
- Primary completion4 Dec 2026 (estimated)
- Study completion4 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Irritant Contact DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Split, School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- European Union
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07286487
- Sponsor's protocol ID
- 2181-198-03-04-25-0072
- Other IDs
- IP-UNIST-35
- Status last verified
- Nov 2025
- First submitted
- 2 Dec 2025
- Last updated
- 18 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
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.
PubMed 34045488Johansen 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.
PubMed 35183605Kang 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.
PubMed 35888607Weisshaar 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.
PubMed 39300011Kowalska 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.
PubMed 31166601