[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100642324":3},{"organization":4,"outcomesModule":7,"designInfo":34,"detailedDescription":44,"studyPopulation":39,"armGroups":45,"interventions":62,"overallOfficials":71,"centralContacts":76,"locations":85,"responsibleParty":103,"collaborators":105,"id":109,"slug":39,"hasResults":110,"nctId":111,"briefTitle":112,"officialTitle":113,"acronym":47,"eligibilityCriteria":114,"healthyVolunteers":115,"sex":116,"minAge":117,"maxAge":118,"enrollmentInfo":119,"targetDuration":39,"studyType":122,"phases":123,"briefSummary":125,"conditions":126,"keywords":129,"overallStatus":133,"whyStopped":39,"lastUpdateSubmitDate":134,"lastUpdatePostDateStruct":135,"startDateStruct":138,"completionDateStruct":140,"leadSponsor":142,"locationsCount":143},{"fullName":5,"class":6},"Wooshin Labottach Co., Ltd.","INDUSTRY",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":29},[9],{"measure":10,"description":11,"timeFrame":12},"Re-epithelialization Rate","Measured as the percentage of wound closure compared to baseline (T0) with standardized photography","day 5 day 7 day 15",[14,18,22,25],{"measure":15,"description":16,"timeFrame":17},"Kinetics of Wound Closure","Time to 50% re-epithelialization","Day 5 day 7",{"measure":19,"description":20,"timeFrame":21},"Subject-Reported Pain","Pain during wear and upon plaster removal assessed via a 100-mm Visual Analogue Scale (VAS)","day 5 day 7",{"measure":23,"description":24,"timeFrame":12},"Scar Quality Assessment","using the Vancouver Scar Scale (VSS) (scoring vascularity, pigmentation, pliability, and height)",{"measure":26,"description":27,"timeFrame":28},"general usability","Assessment of the plaster adherence to the perilesional skin over the treatment period using a 5-Point Adhesion Score 0 (100%) to 4 (0% fallen)","Day 1, day 5, day 7",[30],{"measure":31,"description":32,"timeFrame":33},"Number of AE","Safety outcome","from day 1 to day 15 (all the study duration)",{"allocation":35,"interventionModel":36,"interventionModelDescription":37,"primaryPurpose":38,"observationalModel":39,"timePerspective":39,"maskingInfo":40},"RANDOMIZED","SINGLE_GROUP","Randomized, Single-Blind (assessor blind), Intra-Individual Controlled study","SUPPORTIVE_CARE",null,{"masking":41,"maskingDescription":39,"whoMasked":42},"SINGLE",[43],"OUTCOMES_ASSESSOR","By utilizing a standardized abrasion model (based on the Wigger-Alberti methodology), the study aims to quantify the superior clinical performance of the Plaster compared to a standard plaster (conventional dry) and dry healing (no plaster). This evidence is crucial to demonstrate that the presence of Dexpanthenol provides a significant clinical benefit in terms of healing speed and aesthetic quality of the repaired tissue.",[46,52,58],{"label":47,"type":48,"description":49,"interventionNames":50},"Dexpanthenol","EXPERIMENTAL","On the wound will be applied an experimental Hydrogel plaster with Dexpanthenol",[51],"Device: hydrogel plaster with dexpanthenol",{"label":53,"type":54,"description":55,"interventionNames":56},"Standard plaster","ACTIVE_COMPARATOR","On the wound will be applied a standard plaster, with no active ingredients",[57],"Device: Standard plaster",{"label":59,"type":60,"description":61,"interventionNames":39},"No treatment","NO_INTERVENTION","The wound is not covered or medicated",[63,68],{"type":64,"name":65,"description":66,"armGroupLabels":67,"otherNames":39},"DEVICE","hydrogel plaster with dexpanthenol","On the wound will be applied daily an hydrogel plaster with Dexpanthenol",[47],{"type":64,"name":53,"description":69,"armGroupLabels":70,"otherNames":39},"On the wound will be daily applicated a standard plaster on the market",[53],[72],{"name":73,"affiliation":74,"role":75},"Alessandro Guzzo, MD","la U.O.C. Anestesia Rianimazione degli Ospedali Riuniti Padova Sud con indirizzo via Albere, 30 Monselice","PRINCIPAL_INVESTIGATOR",[77,81],{"name":73,"role":78,"phone":79,"phoneExt":39,"email":80},"CONTACT","+39 0429715610","alessandro.guzzo@aulss6.veneto.it",{"name":82,"role":78,"phone":83,"phoneExt":39,"email":84},"Adolfo Gasparetto, MD","+39 3356641965","adolfogasparetto@nextrasearch.it",[86],{"facility":87,"status":39,"city":88,"state":89,"zip":90,"country":91,"countryCode":92,"cosmosGeoPoint":93,"geoPoint":98,"contacts":99},"la U.O.C. Anestesia Rianimazione degli Ospedali Riuniti Padova Sud","Monselice","PD","35043","Italy","IT",{"type":94,"coordinates":95},"Point",[96,97],11.74984,45.239,{"lat":97,"lon":96},[100,102],{"name":73,"role":78,"phone":101,"phoneExt":39,"email":80},"+39 0429714111",{"name":73,"role":75,"phone":39,"phoneExt":39,"email":39},{"type":104,"investigatorFullName":39,"investigatorTitle":39,"investigatorAffiliation":39,"oldNameTitle":39,"oldOrganization":39},"SPONSOR",[106],{"name":107,"class":108},"Nextrasearch S.r.l.s.","OTHER","100642324",false,"NCT07642973","A Study to Evaluate the Safety and Clinical Performance of a Dexpanthenol Medicated Hydrogel Patch in the Treatment of Standardized Superficial Abrasions","A Randomized, Single-Blind, Intra-Individual Controlled Study to Evaluate the Safety and Clinical Performance of a Dexpanthenol Medicated Hydrogel Patch in the Treatment of Standardized Superficial Abrasions","Inclusion Criteria:\n\n* Healthy male or female volunteers aged 18 to 64 years (inclusive).\n* Informed consent form signed voluntarily before any study-related procedure.\n* Subjects willing and able to comply with all study protocol requirements, including scheduled visits and home-wear restrictions.\n* Intact, healthy skin on both volar forearms (free of tattoos, scars, sunburns, or active skin lesions in the designated test areas).\n* Agree to take precautions to prevent pregnancy (applicable only to non-menopausal women), including abstinence, intrauterine devices (IUDs), progestogen implants, combined estrogenic-progestogen contraceptives, the use of condoms;\n\nExclusion Criteria:\n\n* Known hypersensitivity or allergy to Dexpanthenol, hydrogel components, acrylic adhesives, or any component of the investigational devices.\n* History of keloid formation, hypertrophic scarring, or abnormal wound healing.\n* Active dermatological conditions (e.g., psoriasis, eczema, atopic dermatitis, active infections) on the upper extremities.\n* History of diabetes mellitus, peripheral vascular disease, or arterial\u002Fvenous microangiopathy.\n* Systemic treatment with corticosteroids, immunosuppressive drugs, Anticoagulants, antiplatelet agents or cytostatic agents within 4 weeks prior to Baseline, or anticipated need during the study.\n* Topical treatment (steroids, retinoids, antibiotics, or moisturizers) applied to the volar forearms within 2 weeks prior to Baseline.\n* Active heavy smokers (more than 10 cigarettes per day) or users of nicotine-replacement therapies (nicotine alters cutaneous microcirculation and significantly impairs wound healing kinetics)\n* Pregnant or lactating women, or women of childbearing potential not using highly effective contraception (see inclusion criteria).\n* Not willing and able to comply with all study protocol requirements",true,"ALL","18 Years","64 Years",{"count":120,"type":121},40,"ESTIMATED","INTERVENTIONAL",[124],"NA","Clinical evaluation of a Dexpanthenol-medicated wound plaster on standardized superficial skin abrasions",[127,128],"Skin Wounds","Abrasion",[130,131,132],"superficial wounds","dexpanthenol","plaster","NOT_YET_RECRUITING","2026-06-12",{"date":136,"type":137},"2026-06-16","ACTUAL",{"date":139,"type":121},"2026-09",{"date":141,"type":121},"2026-12",{"name":5,"class":6},1]