[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100625933":3},{"organization":4,"armGroups":7,"interventions":17,"overallOfficials":11,"centralContacts":23,"locations":11,"responsibleParty":32,"collaborators":36,"id":40,"slug":41,"hasResults":42,"nctId":43,"briefTitle":44,"officialTitle":45,"acronym":11,"eligibilityCriteria":46,"healthyVolunteers":42,"sex":47,"minAge":48,"maxAge":49,"enrollmentInfo":50,"targetDuration":11,"studyType":53,"phases":54,"briefSummary":56,"conditions":57,"keywords":63,"overallStatus":66,"whyStopped":11,"lastUpdateSubmitDate":67,"lastUpdatePostDateStruct":68,"startDateStruct":71,"completionDateStruct":73,"leadSponsor":75,"locationsCount":11},{"fullName":5,"class":6},"University of Aarhus","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention","EXPERIMENTAL",null,[13],"Combination Product: Papilocare Vaginal Gel",{"label":15,"type":16,"description":11,"interventionNames":11},"Control","NO_INTERVENTION",[18],{"type":19,"name":20,"description":21,"armGroupLabels":22,"otherNames":11},"COMBINATION_PRODUCT","Papilocare Vaginal Gel","Women (n=35) will apply a CV-based vaginal gel (Papilocare®) daily for 21 days for 3 months. Afterward, the gel should be used every other day for an additional 3 months. Every month includes a 7-day break due to menstruation (28 days cycle).",[9],[24,29],{"name":25,"role":26,"phone":27,"phoneExt":11,"email":28},"Pinar Bor, Professor, MD, Ph.D.","CONTACT","22504767","isipinbo@rm.dk",{"name":30,"role":26,"phone":11,"phoneExt":11,"email":31},"Vibe M Bertelsen, Post.Doc, MD, Ph.D.","vibebert@rm.dk",{"type":33,"investigatorFullName":34,"investigatorTitle":35,"investigatorAffiliation":5,"oldNameTitle":11,"oldOrganization":11},"PRINCIPAL_INVESTIGATOR","Vibe Munk Bertelsen","Post.doc, MD, Ph.D",[37],{"name":38,"class":39},"Procare Health Iberia S.L.","INDUSTRY","100625933","early-phase-1-effectiveness-of-a-vaginal-gel-on-cin12-regression-and-hpv-clearance-100625933",false,"NCT07429071","Effectiveness of a Vaginal Gel on CIN1\u002F2 Regression and HPV Clearance.","Effectiveness of a Non-Invasive Treatment Using a Vaginal Gel in Promoting HPV Clearance and Regression of Cervical Intraepithelial Neoplasia: A Randomized Controlled Trial.","Inclusion Criteria:\n\n* Positive HPV test\n* Underwent colposcopy with subsequent histopathological findings of CIN1 or CIN2\n* Allocated to a 'watchful waiting' management strategy.\n* Understand Danish, written and orally.\n\nExclusion Criteria:\n\n* Pregnancy or breastfeeding\n* Unexplained bleeding\n* Immunosuppressive\u002Fmodulatory diseases or treatment\n* Cancer or cancer related diseases","FEMALE","30 Years","50 Years",{"count":51,"type":52},70,"ESTIMATED","INTERVENTIONAL",[55],"EARLY_PHASE1","The goal of this clinical trial is to evaluate whether a Coriolus versicolor-based vaginal gel promotes regression of CIN1\u002FCIN2 and facilitates HPV clearance in women aged 30-50 years diagnosed with CIN1 or CIN2 and HPV. In addition, the study will assess patient satisfaction, treatment compliance and characterize the vaginal microbiome.\n\nThe primary outcomes therefore is:\n\n* the regression of the cervical dysplasia from baseline to the follow-up (6 months), which will be assessed through either liquid-based cytology and\u002For histopathology (biopsy).\n* HPV clearance from baseline to follow-up (6 months)\n\nIn this randomized controlled study, eligible participants will be randomized 1:1 into two groups:\n\n1. Intervention group: Women (n=35) will apply a CV-based vaginal gel (Papilocare®) daily for 21 days for 3 months. Afterward, the gel should be used every other day for an additional 3 months. Every month includes a 7-day break due to menstruation (28 days cycle).\n2. Control group; Women (n=35) will follow the conventional \"wait and see\" approach.",[58,59,60,61,62],"Womens Health","Cervical Dysplasia","Cervical Intraepithelial Neoplasia (CIN)","Non-invasive Treatment","Human Papilloma Virus (HPV)",[58,59,60,64,65],"Human Papillomavirus (HPV)","Non-Invasive Treatments","NOT_YET_RECRUITING","2026-03-02",{"date":69,"type":70},"2026-03-04","ACTUAL",{"date":72,"type":52},"2026-03",{"date":74,"type":52},"2026-09",{"name":5,"class":6}]