[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100614968":3},{"organization":4,"armGroups":7,"interventions":47,"overallOfficials":53,"centralContacts":53,"locations":70,"responsibleParty":87,"collaborators":89,"id":92,"slug":93,"hasResults":94,"nctId":95,"briefTitle":96,"officialTitle":97,"acronym":53,"eligibilityCriteria":98,"healthyVolunteers":99,"sex":100,"minAge":101,"maxAge":53,"enrollmentInfo":102,"targetDuration":53,"studyType":105,"phases":106,"briefSummary":108,"conditions":109,"keywords":53,"overallStatus":111,"whyStopped":53,"lastUpdateSubmitDate":112,"lastUpdatePostDateStruct":113,"startDateStruct":116,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"University of Split, School of Medicine","OTHER",[8,13,19,25,30,35,39,43],{"label":9,"type":6,"description":10,"interventionNames":11},"No Treatment and Intact skin","No topical product will be applied. Intact skin.",[12],"Other: No Treatment",{"label":14,"type":15,"description":16,"interventionNames":17},"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.",[18],"Other: Placebo",{"label":20,"type":21,"description":22,"interventionNames":23},"Glycyrrhetinic Acid (lower dose) and Intact skin","EXPERIMENTAL","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.",[24],"Other: Lower Dose Glycyrrhetinic Acid",{"label":26,"type":21,"description":27,"interventionNames":28},"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.",[29],"Other: Higher Dose Glycyrrhetinic Acid",{"label":31,"type":6,"description":32,"interventionNames":33},"No Treatment and Irritation","No topical product will be applied. SLS induced skin irritation.",[34,12],"Procedure: SLS induced irritation",{"label":36,"type":15,"description":37,"interventionNames":38},"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.",[34,18],{"label":40,"type":21,"description":41,"interventionNames":42},"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.",[34,24],{"label":44,"type":21,"description":45,"interventionNames":46},"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",[34,29],[48,54,58,62,66],{"type":49,"name":50,"description":51,"armGroupLabels":52,"otherNames":53},"PROCEDURE","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\u002Fv sodium lauryl sulfate (SLS) aqueous solution under occlusion for a defined period to create a controlled model of acute irritant dermatitis.\n\nThe contralateral forearm will remain untreated and serve as intact skin for comparison.\n\nFollowing the induction phase, all test products (placebo and active formulations) will be applied to both irritated and intact sites according to the treatment allocation.",[44,40,31,36],null,{"type":6,"name":55,"description":56,"armGroupLabels":57,"otherNames":53},"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.",[9,31],{"type":6,"name":59,"description":60,"armGroupLabels":61,"otherNames":53},"Placebo","Topical formulation identical in composition to the active preparations but without glycyrrhetinic acid.\n\nUsed 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.",[14,36],{"type":6,"name":63,"description":64,"armGroupLabels":65,"otherNames":53},"Lower Dose Glycyrrhetinic Acid","Topical formulation containing a lower concentration of 18β-glycyrrhetinic acid.\n\nDesigned to assess the effects of the active compound at a lower dose on skin barrier recovery and skin parameters following SLS-induced irritation.\n\nApplied daily to designated test sites on both irritated and intact forearm areas for the duration of the study.",[20,40],{"type":6,"name":67,"description":68,"armGroupLabels":69,"otherNames":53},"Higher Dose Glycyrrhetinic Acid","Topical formulation containing a higher concentration of 18β-glycyrrhetinic acid.\n\nDesigned to assess the effects of the active compound at a lower dose on skin barrier recovery and skin parameters following SLS-induced irritation.\n\nApplied daily to designated test sites on both irritated and intact forearm areas for the duration of the study.",[26,44],[71],{"facility":72,"status":53,"city":73,"state":53,"zip":74,"country":75,"countryCode":76,"cosmosGeoPoint":77,"geoPoint":82,"contacts":83},"University of Split School of Medicine","Split","21000","Croatia","HR",{"type":78,"coordinates":79},"Point",[80,81],16.43915,43.50891,{"lat":81,"lon":80},[84],{"name":85,"role":86,"phone":53,"phoneExt":53,"email":53},"Dario Leskur, asst. prof., MPharm, PhD","PRINCIPAL_INVESTIGATOR",{"type":88,"investigatorFullName":53,"investigatorTitle":53,"investigatorAffiliation":53,"oldNameTitle":53,"oldOrganization":53},"SPONSOR",[90],{"name":91,"class":6},"European Union","100614968","glycyrrhetinic-acid-and-acute-irritant-dermatitis-100614968",false,"NCT07286487","Glycyrrhetinic Acid and Acute Irritant Dermatitis","Effects of Glycyrrhetinic Acid on Human Skin in an Acute Irritant Contact Dermatitis Model","Inclusion Criteria:\n\n* Healthy adult participants aged 18 years or older, of any sex.\n* Intact, healthy skin at the test sites.\n* No use of systemic or topical corticosteroids, immunomodulators, or antihistamines within the previous three months.\n* No use of topical emollients on the test sites within the previous seven days.\n\nExclusion Criteria:\n\n* Pregnant women, women suspected of being pregnant, and breastfeeding women.\n* Non-compliance with the study protocol.\n* Voluntary withdrawal or personal decision not to continue participation.",true,"ALL","18 Years",{"count":103,"type":104},30,"ESTIMATED","INTERVENTIONAL",[107],"NA","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.\n\n18β-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.\n\nTopical application of formulations containing 18β-glycyrrhetinic acid will improve skin parameter disturbances caused by irritation induced with sodium lauryl sulfate.\n\nThis 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.\n\nFunding:\n\nFunded 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.",[110],"Irritant Contact Dermatitis","NOT_YET_RECRUITING","2026-02-12",{"date":114,"type":115},"2026-02-13","ACTUAL",{"date":117,"type":104},"2026-03-01",{"date":119,"type":104},"2027-04-25",{"name":5,"class":6},1]