[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100588657":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":29,"centralContacts":33,"locations":11,"responsibleParty":41,"collaborators":45,"id":49,"slug":50,"hasResults":51,"nctId":52,"briefTitle":53,"officialTitle":54,"acronym":11,"eligibilityCriteria":55,"healthyVolunteers":51,"sex":56,"minAge":57,"maxAge":58,"enrollmentInfo":59,"targetDuration":11,"studyType":62,"phases":63,"briefSummary":66,"conditions":67,"keywords":69,"overallStatus":75,"whyStopped":11,"lastUpdateSubmitDate":76,"lastUpdatePostDateStruct":77,"startDateStruct":80,"completionDateStruct":82,"leadSponsor":84,"locationsCount":11},{"fullName":5,"class":6},"University Hospital, Geneva","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Study arm (verteporfin)","EXPERIMENTAL",null,[13],"Drug: Verteporfin Injection",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo arm","PLACEBO_COMPARATOR",[18],"Drug: NaCl (placebo)",[20,25],{"type":21,"name":22,"description":23,"armGroupLabels":24,"otherNames":11},"DRUG","NaCl (placebo)","During the safety margin excision, the placebo (NaCl) will be injected into the wound before suturing.",[15],{"type":21,"name":26,"description":27,"armGroupLabels":28,"otherNames":11},"Verteporfin Injection","During the safety margin excision, the study drug (Verteporfin) will be injected into the wound before suturing.",[9],[30],{"name":31,"affiliation":5,"role":32},"Jöri Pünchera, M.D.","PRINCIPAL_INVESTIGATOR",[34,38],{"name":31,"role":35,"phone":36,"phoneExt":11,"email":37},"CONTACT","+41223729450","jpuc@hug.ch",{"name":39,"role":35,"phone":36,"phoneExt":11,"email":40},"Michael Mühlstädt, M.D.","mmuh@hug.ch",{"type":42,"investigatorFullName":43,"investigatorTitle":44,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"SPONSOR_INVESTIGATOR","Jöri Pünchera","attending physician, M.D.",[46,48],{"name":47,"class":6},"University of Geneva, Switzerland",{"name":5,"class":6},"100588657","phase-1-effect-of-yap1-inhibition-in-surgical-wounds-100588657",false,"NCT06944249","Effect of YAP1-inhibition in Surgical Wounds.","The Role of YAP1 in Fibrosis Explored Through Its Local Inhibition With Verteporfin in Surgical Wounds: A Randomized Controlled, Prospective, Evaluator-blinded Proof-of-concept Study.","Inclusion Criteria:\n\n* Willing and able to provide informed consent as documented by signature\n* Age is \\>\u002F= 18 years and \\\u003C 56 years (differently said: starting from the 18th birthday to completion of their 55 years)\n* Indication for a safety margin excision (5 mm laterally) due to melanoma in situ or severe dysplastic nevi previously completely excised\n* Length of initial scar from 15 mm to 50 mm\n* The initial lesion was excised on the back (to ensure that all patients undergo their safety margin excision within the internationally accepted timeframe, we will also accept patients requiring the procedure at another anatomical site if a particular batch cannot be filled within 4 weeks of its first patient's enrollment)\n\nExclusion Criteria:\n\n* Clinical adenopathy (cervical, axillar, inguinal) defined as a lymph node of more than 1 cm diameter\n* Melanoma in situ of lentigo maligna or acral lentiginous type\n* Head and neck location\n* Diameter of initial lesion above or equal to 3 cm\n* Known and documented hypersensitivity to Verteporfin or to any of its excipients: lactose monohydrate, egg phosphatidylglycerol (to simplify we will exclude patients with known and documented allergy to egg protein), dimyristoyl phosphatidylcholine, ascorbyl palmitate, butylated hydroxytoluene (E321)\n* Porphyria\n* Moderate hepatic dysfunction referred to as any of the following: AST \\>1.2x upper normal range, ALT \\>1.2x upper normal range, decreased albumin level, prolongation of PT\n* Biliary obstruction referred to as any of the following: ALP \\>1.2x upper normal range, GGT \\>1.2x upper normal range, anormal bilirubin level\n* Pregnancy referred to as: positive beta-hCG blood test\n* Breast-feeding\n* Planned pregnancy in the next 6 months\n* History of either one of the following: keloids, scleroderma, morphea, lupus erythematosus, nephrogenic systemic fibrosis, graft-versus-host disease, lichen sclerosus, eosinophilic fasciitis, Ehlers-Danlos syndrome, cutis laxa, Marfan syndrome, or pseudoxanthoma elasticum","ALL","18 Years","55 Years",{"count":60,"type":61},24,"ESTIMATED","INTERVENTIONAL",[64,65],"PHASE1","PHASE2","When we get injured, our body naturally tries to heal. In adults, this healing often leads to scars - thick, stiff tissue known as fibrotic tissue. Unlike normal tissue, fibrotic tissue doesn't function properly and can cause serious health problems, depending on the affected organ. Once it forms, fibrosis is usually permanent.\n\nA good example of the fibrosis process is the healing of our skin: after a cut or surgery, the resulting scar is a type of fibrosis. Special cells called fibroblasts are key players in this process.\n\nOur study looks at a drug called verteporfin, which is already approved both in Europe and the U.S. Previous research on mice and human cells suggests it can reduce or even prevent fibrosis.\n\nWe are now testing, clinically, histologically and by scRNA-seq, whether injecting verteporfin into the skin during wound healing, specifically after surgical procedures, can prevent thick, rigid scars from forming. Since the skin is easy to observe and sample, it offers a great model for studying this.\n\nWill verteporfin have an impact on how surgical wounds heal? That's what we aim to find out.",[68],"Scar Formation",[70,71,72,73,74],"YAP1","Verteporfin","Scar","Fibrosis","Wound healing","NOT_YET_RECRUITING","2025-04-17",{"date":78,"type":79},"2025-04-25","ACTUAL",{"date":81,"type":61},"2025-05-08",{"date":83,"type":61},"2026-07-31",{"name":43,"class":6}]