[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100644953":3},{"organization":4,"outcomesModule":7,"designInfo":20,"detailedDescription":19,"studyPopulation":19,"armGroups":30,"interventions":47,"overallOfficials":19,"centralContacts":54,"locations":60,"responsibleParty":76,"collaborators":19,"id":78,"slug":19,"hasResults":79,"nctId":80,"briefTitle":81,"officialTitle":82,"acronym":19,"eligibilityCriteria":83,"healthyVolunteers":84,"sex":85,"minAge":86,"maxAge":87,"enrollmentInfo":88,"targetDuration":19,"studyType":91,"phases":92,"briefSummary":94,"conditions":95,"keywords":97,"overallStatus":63,"whyStopped":19,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"University of Split, School of Medicine","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":19,"otherOutcomes":19},[9,13,16],{"measure":10,"description":11,"timeFrame":12},"Change in Transepidermal Water Loss (TEWL)","Skin barrier function will be assessed by measuring transepidermal water loss using a Tewameter TM 300 probe. Values will be expressed in g\u002Fm²\u002Fh","Baseline (prior to SLS application) and Days 1, 2, 3, 4, and 7 (change from baseline).",{"measure":14,"description":15,"timeFrame":12},"Change in Skin Hydration","Hydration of the stratum corneum will be assessed using a Corneometer CM 825 probe.",{"measure":17,"description":18,"timeFrame":12},"Change in Skin Erythema","Skin erythema will be assessed using a Mexameter MX 18 probe.",null,{"allocation":21,"interventionModel":22,"interventionModelDescription":23,"primaryPurpose":24,"observationalModel":19,"timePerspective":19,"maskingInfo":25},"RANDOMIZED","PARALLEL","This is a randomized, placebo-controlled, intra-individual study in which each participant will receive all study conditions simultaneously on the forearms. Irritant contact dermatitis will be induced at designated skin sites using sodium lauryl sulfate (SLS) under occlusion. One SLS-treated site will be treated with a cream containing Helichrysum italicum extract, a second SLS-treated site will be treated with a placebo cream, and a third SLS-treated site will remain untreated to assess natural skin barrier recovery. In addition, the cream containing Helichrysum italicum extract will be applied to a separate area of healthy, intact skin to evaluate its effects and tolerability on non-irritated skin. The allocation of treatment sites will be determined according to the randomization protocol.","TREATMENT",{"masking":26,"maskingDescription":19,"whoMasked":27},"DOUBLE",[28,29],"PARTICIPANT","OUTCOMES_ASSESSOR",[31,37,43],{"label":32,"type":33,"description":34,"interventionNames":35},"Helichrysum italicum Extract Cream","EXPERIMENTAL","Participants will receive a topical emollient cream containing Helichrysum italicum extract applied to an SLS-treated skin site.",[36],"Other: Helichrysum italicum Extract Cream",{"label":38,"type":39,"description":40,"interventionNames":41},"Placebo Cream","PLACEBO_COMPARATOR","Participants will receive the same emollient cream base without Helichrysum italicum extract applied to an SLS-treated skin site.",[42],"Other: Placebo Cream",{"label":44,"type":45,"description":46,"interventionNames":19},"Untreated Control Site","NO_INTERVENTION","An SLS-treated skin site that will not receive any topical treatment and will serve as a control for natural skin barrier recovery.",[48,51],{"type":6,"name":32,"description":49,"armGroupLabels":50,"otherNames":19},"Topical emollient cream containing Helichrysum italicum extract",[32],{"type":6,"name":38,"description":52,"armGroupLabels":53,"otherNames":19},"A moisturizing cream without Helichrysum italicum extract applied to the designated skin site.",[38],[55],{"name":56,"role":57,"phone":58,"phoneExt":19,"email":59},"Josipa Bukić","CONTACT","+385917933753","jbukic@mefst.hr",[61],{"facility":62,"status":63,"city":64,"state":19,"zip":65,"country":66,"countryCode":67,"cosmosGeoPoint":68,"geoPoint":73,"contacts":74},"University of Split School of Medicine","RECRUITING","Split","21000","Croatia","HR",{"type":69,"coordinates":70},"Point",[71,72],16.43915,43.50891,{"lat":72,"lon":71},[75],{"name":56,"role":57,"phone":58,"phoneExt":19,"email":59},{"type":77,"investigatorFullName":19,"investigatorTitle":19,"investigatorAffiliation":19,"oldNameTitle":19,"oldOrganization":19},"SPONSOR","100644953",false,"NCT07676253","Helichrysum Italicum Extract in Irritant Contact Dermatitis","Assessment of the Effect of Helichrysum Italicum Extract in Irritant Contact Dermatitis: A Randomized Controlled Clinical Trial","Inclusion Criteria:\n\n* healthy volunteers who gave written informed consent\n\nExclusion Criteria:\n\n* skin disease\n* skin damage on measurement sites\n* use of corticosteroids, antihistamines and immunomodulators a month prior the inclusion and during the trial\n* pregnancy or breastfeeding\n* immunosuppression\n* allergic or irritant reactions to the constituents of the cream",true,"ALL","18 Years","50 Years",{"count":89,"type":90},30,"ESTIMATED","INTERVENTIONAL",[93],"NA","The goal of this clinical trial is to evaluate the efficacy and safety of a topical cream containing Immortelle (Helichrysum italicum) extract in promoting skin barrier recovery and reducing signs of irritant contact dermatitis in healthy adult participants.\n\nThe main questions it aims to answer are:\n\n* Does topical application of Helichrysum italicum extract improve skin barrier recovery following experimentally induced irritant contact dermatitis?\n* Does the cream containing Helichrysum italicum extract reduce transepidermal water loss and erythema, and improve skin hydration compared to a standard moisturizing cream?\n* Is the topical application of Helichrysum italicum extract safe and well tolerated?\n\nResearchers will compare skin sites treated with a cream containing Helichrysum italicum extract, placebo-treated skin sites, and untreated skin sites to determine whether the addition of the extract provides additional benefits in skin barrier recovery.\n\nParticipants will:\n\n* Undergo induction of irritant contact dermatitis using sodium lauryl sulfate (SLS) under occlusion.\n* Apply a cream containing Helichrysum italicum extract to one designated skin site and a placebo cream to another designated skin site twice daily throughout the study period.\n* Have an additional SLS-treated skin site left untreated to assess natural skin barrier recovery.\n* Apply the cream containing Helichrysum italicum extract to a separate area of healthy, intact skin.\n* Attend daily study visits for non-invasive assessments of skin barrier function, including transepidermal water loss, skin hydration, and erythema measurements.",[96],"Skin Barrier Disruption and Recovery",[98,99,100,101],"Helichrysum italicum","Immortelle","Irritant contact dermatitis","Skin barrier recovery","2026-06-23",{"date":104,"type":105},"2026-06-30","ACTUAL",{"date":107,"type":90},"2026-06",{"date":109,"type":90},"2027-06",{"name":5,"class":6},1]