[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100611423":3},{"organization":4,"armGroups":7,"interventions":25,"overallOfficials":30,"centralContacts":40,"locations":46,"responsibleParty":60,"collaborators":30,"id":64,"slug":65,"hasResults":66,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":70,"eligibilityCriteria":71,"healthyVolunteers":66,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":30,"studyType":78,"phases":79,"briefSummary":81,"conditions":82,"keywords":84,"overallStatus":85,"whyStopped":30,"lastUpdateSubmitDate":86,"lastUpdatePostDateStruct":87,"startDateStruct":90,"completionDateStruct":92,"leadSponsor":94,"locationsCount":95},{"fullName":5,"class":6},"Jagiellonian University","OTHER",[8,14,20],{"label":9,"type":10,"description":11,"interventionNames":12},"Platelet-Rich Plasma (PRP) Treatment","EXPERIMENTAL","Participants receive subcutaneous and submucosal injections of 5 ml autologous platelet-rich plasma (PRP) prepared using the Arthrex ACP Max™ system. PRP is injected into clinically affected vulvar areas and sites of itching or pain. Procedure performed once at study start. Outcomes are evaluated at baseline, 3 months, and 6 months; a vulvar biopsy is taken at 6 months.",[13],"Biological: Platelet-Rich Plasma (PRP) Treatment",{"label":15,"type":16,"description":17,"interventionNames":18},"Topical High-Potency Corticosteroid","ACTIVE_COMPARATOR","Participants apply clobetasol propionate 0.05% cream (Dermovate) twice daily for the first 3 weeks and once daily for the following 3 weeks. Follow-up assessments occur at baseline, 3 months, and 6 months; a vulvar biopsy is taken at 6 months.",[19],"Drug: Clobetasol Propionate 0.05% Cream (Dermovate)",{"label":21,"type":16,"description":22,"interventionNames":23},"Topical Calcineurin Inhibitor","Participants apply pimecrolimus cream (Elidel) twice daily for 3 weeks and once daily for the following 3 weeks. Follow-up assessments occur at baseline, 3 months, and 6 months; a vulvar biopsy is taken at 6 months.",[24],"Drug: Pimecrolimus Cream (Elidel)",[26,31,36],{"type":27,"name":9,"description":28,"armGroupLabels":29,"otherNames":30},"BIOLOGICAL","Autologous platelet-rich plasma (5 ml) prepared using the Arthrex ACP Max™ Platelet-Rich Plasma System is injected subcutaneously and submucosally into clinically affected vulvar areas and sites of itching or pain. PRP is administered once at baseline following standard aseptic technique.",[9],null,{"type":32,"name":33,"description":34,"armGroupLabels":35,"otherNames":30},"DRUG","Clobetasol Propionate 0.05% Cream (Dermovate)","Participants apply clobetasol propionate 0.05% cream topically twice daily for the first 3 weeks, followed by once daily for the next 3 weeks. This regimen represents standard high-potency corticosteroid therapy for vulvar lichen sclerosus.",[15],{"type":32,"name":37,"description":38,"armGroupLabels":39,"otherNames":30},"Pimecrolimus Cream (Elidel)","Participants apply pimecrolimus cream topically twice daily for 3 weeks, followed by once daily for the next 3 weeks. This regimen represents topical calcineurin inhibitor therapy for vulvar lichen sclerosus.",[21],[41],{"name":42,"role":43,"phone":44,"phoneExt":30,"email":45},"Milosz Pietrus, MD PhD","CONTACT","+48 602 779 298","milosz.pietrus@uj.edu.pl",[47],{"facility":48,"status":30,"city":49,"state":50,"zip":51,"country":52,"countryCode":53,"cosmosGeoPoint":54,"geoPoint":59,"contacts":30},"Klinika Ginekologii i Ginekologii Onkologicznej, Szpital Uniwersytecki w Krakowie","Krakow","Małopolska","31-261","Poland","PL",{"type":55,"coordinates":56},"Point",[57,58],19.93658,50.06143,{"lat":58,"lon":57},{"type":61,"investigatorFullName":62,"investigatorTitle":63,"investigatorAffiliation":5,"oldNameTitle":30,"oldOrganization":30},"SPONSOR_INVESTIGATOR","Milosz Pietrus","MD PhD","100611423","treatment-of-vulvar-lichen-sclerosus-with-corticosteroid-ointment-calcineurin-inhibitor-ointment-and-platelet-rich-plasma-prp-therapy-100611423",false,"NCT07240389","Treatment of Vulvar Lichen Sclerosus With Corticosteroid Ointment, Calcineurin Inhibitor Ointment, and Platelet-Rich Plasma (PRP) Therapy.","Evaluation of Therapeutic Outcomes in Vulvar Lichen Sclerosus Treated With Corticosteroids, Calcineurin Inhibitors, and Platelet-rich Plasma (PRP).","VULIS-3T","Inclusion Criteria:\n\n1. Age 30 to 80 years.\n2. Clinical diagnosis of vulvar lichen sclerosus confirmed by histopathological examination.\n3. Ability and willingness to provide written informed consent for participation in the study.\n4. Ability to comply with study procedures, including questionnaire completion and follow-up visits at baseline, 3 months, and 6 months.\n\nExclusion Criteria:\n\n1. Lack of written informed consent to participate in the study.\n2. Prior treatment for vulvar lichen sclerosus (any systemic or topical therapy targeted at VLS).\n3. Current or past vulvar neoplasia, including vulvar intraepithelial neoplasia (VIN) or vulvar carcinoma.\n4. Other organic or dermatologic causes of vulvar symptoms that could interfere with diagnosis or outcome evaluation.\n5. Any condition that, in the opinion of the investigator, would interfere with study participation, follow-up, or accurate interpretation of results.","FEMALE","30 Years","80 Years",{"count":76,"type":77},45,"ESTIMATED","INTERVENTIONAL",[80],"NA","Vulvar lichen sclerosus (VLS) is a chronic inflammatory skin condition that affects the vulvar area, often causing itching, burning, and pain, and may lead to scarring and narrowing of the vaginal opening. The condition significantly reduces the quality of life and may increase the risk of cancerous changes if left untreated.\n\nThis clinical study aims to evaluate and compare three commonly used treatment methods for women with biopsy-confirmed vulvar lichen sclerosus:\n\nTopical corticosteroid therapy (clobetasol propionate 0.05%),\n\nTopical calcineurin inhibitor therapy (pimecrolimus), and\n\nPlatelet-rich plasma (PRP) injections, which use the patient's own blood plasma rich in growth factors to support tissue healing.\n\nA total of 45 participants aged 30 to 80 years will be enrolled and assigned to one of the three treatment groups. The effectiveness of therapy will be assessed using standardized questionnaires about symptoms and quality of life, as well as microscopic evaluation of tissue samples before and after treatment.\n\nThe study seeks to determine whether platelet-rich plasma (PRP) can serve as a safe and effective first-line treatment option for vulvar lichen sclerosus and to improve our understanding of the best therapeutic approaches for this chronic disease.",[83],"Vulvar Lichen Sclerosus",[83],"NOT_YET_RECRUITING","2025-11-16",{"date":88,"type":89},"2025-11-20","ACTUAL",{"date":91,"type":77},"2025-12-01",{"date":93,"type":77},"2027-01-31",{"name":62,"class":6},1]