[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100566915":3},{"organization":4,"armGroups":7,"interventions":18,"overallOfficials":24,"centralContacts":28,"locations":34,"responsibleParty":52,"collaborators":11,"id":55,"slug":56,"hasResults":57,"nctId":58,"briefTitle":59,"officialTitle":59,"acronym":11,"eligibilityCriteria":60,"healthyVolunteers":61,"sex":62,"minAge":63,"maxAge":64,"enrollmentInfo":65,"targetDuration":11,"studyType":68,"phases":69,"briefSummary":72,"conditions":73,"keywords":11,"overallStatus":36,"whyStopped":11,"lastUpdateSubmitDate":75,"lastUpdatePostDateStruct":76,"startDateStruct":79,"completionDateStruct":81,"leadSponsor":83,"locationsCount":84},{"fullName":5,"class":6},"Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Infiltrative treatment with CB-PRP Group","EXPERIMENTAL",null,[13],"Biological: Infiltrative treatment with CB-PRP",{"label":15,"type":16,"description":11,"interventionNames":17},"Placebo infiltrative treatment Group","PLACEBO_COMPARATOR",[13],[19],{"type":20,"name":21,"description":22,"armGroupLabels":23,"otherNames":11},"BIOLOGICAL","Infiltrative treatment with CB-PRP","Injection of CB-PRP or placebo into the vulvar site. Three treatments are planned four weeks apart. Three and six months after the last treatment with CB-PRP\u002F placebo each participant will be re-evaluated by vulvoscopy and biopsy, and will be given validated questionnaires to assess satisfaction, symptoms, and quality of life, psychological state, and sexual function.",[9,15],[25],{"name":26,"affiliation":5,"role":27},"veronica Boero, MD","PRINCIPAL_INVESTIGATOR",[29],{"name":30,"role":31,"phone":32,"phoneExt":11,"email":33},"Veronica Boero, MD","CONTACT","0255032318","veronica.boero@policlinico.mi.it",[35],{"facility":5,"status":36,"city":37,"state":37,"zip":38,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"RECRUITING","Milan","20122","Italy","IT",{"type":42,"coordinates":43},"Point",[44,45],9.18951,45.46427,{"lat":45,"lon":44},[48,49],{"name":30,"role":31,"phone":11,"phoneExt":11,"email":33},{"name":50,"role":31,"phone":11,"phoneExt":11,"email":51},"Giulia Cetera, MD","giuliaemily.cetera@gmail.com",{"type":27,"investigatorFullName":53,"investigatorTitle":54,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"Direzione Ginecologia","Principal Investigator","100566915","phase-1-use-of-platelet-rich-plasma-from-cord-blood-vs-placebo-in-the-treatment-of-vulvar-lichen-sclerosus-100566915",false,"NCT06661382","Use of Platelet Rich Plasma from Cord Blood Vs Placebo in the Treatment of Vulvar Lichen Sclerosus","Inclusion Criteria:\n\n* women with VLS (clinical\u002Fhistological diagnosis)\n* good health conditions\n* written informed consent signed and dated by the patient\n\nExclusion Criteria:\n\n* pregnancy\n* coagulopathies, platelet disorders, cardiovascular and\u002For respiratory diseases\n* ongoing major infections\n* previous vulvar surgery (e.g., lipostructure and\u002For previous PRP)",true,"FEMALE","18 Years","80 Years",{"count":66,"type":67},100,"ESTIMATED","INTERVENTIONAL",[70,71],"PHASE1","PHASE2","Vulvar lichen Sclerosus (VLS) is a cutaneous-mucosal dermatosis that causes in the adult female vulvar itching and burning due to scratching abrasions. Dyspareunia is often associated . The areas most affected are the labia minora, the periclitoral area, the navicular dimple, and the perianal area. The placement of VLS in the context of immune-mediated dermatoses is the basis of the rationale for treatment with high potency topical corticosteroids. However, in some cases, local corticosteroid therapy is not sufficient resulting in a significant impact on the quality of life of the patient. This gives rise to the need to identify new treatments such as regenerative medicine.\n\nThe term PRP (Platelet Rich Plasma) is used to describe a blood product generated by a two-step centrifugation process of whole blood of a patient to produce a concentration of platelets in a small volume of plasma. PRP can be produced from autologous, homologous blood or from cord blood (CB-PRP).\n\nOur objective is to evaluate the efficacy of CB-PRP versus placebo in the treatment of VLS.",[74],"Vulvar Lichen Sclerosus","2024-10-25",{"date":77,"type":78},"2024-10-28","ACTUAL",{"date":80,"type":78},"2023-01-24",{"date":82,"type":67},"2024-12-24",{"name":5,"class":6},1]