[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"vulvar-hsil\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:vulvar-hsil":29},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,63],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":40,"overallStatus":50,"whyStopped":4,"lastUpdateSubmitDate":51,"lastUpdatePostDateStruct":52,"startDateStruct":55,"completionDateStruct":57,"leadSponsor":59,"locationsCount":62},"100521874","phase-2-phase-ii-study-of-artesunate-ointment-for-the-treatment-of-vulvar-high-grade-squamous-intraepithelial-lesions-vulvar-hsil-vin23-100521874",false,"NCT06075264","Phase II Study of Artesunate Ointment for the Treatment of Vulvar High Grade Squamous Intraepithelial Lesions (Vulvar HSIL, VIN2\u002F3)","A Phase II Double-blind, Placebo-controlled, Randomized Trial of Topical Artesunate Ointment for the Treatment of Patients With Vulvar High-grade Squamous Intraepithelial Lesions (Vulvar HSIL)","ART-VIN IIB","Inclusion Criteria:\n\n* Adult women age ≥ 18 years\n* Capable of informed consent\n* Able to collaborate with planned follow-up (transportation, compliance history, etc)\n* Biopsy diagnosis of high-grade vulvar dysplasia (VIN2, VIN3, VIN2\u002F3, HSIL), including both new and recurrent disease. A biopsy diagnosis of vulvar high-grade squamous intraepithelial lesion within the previous 3 months which was not excised or otherwise treated may be accepted for study entry.\n* Positive HPV test at study entry (any genotype).\n* Women of childbearing potential agree to use birth control during the dosing phase (through week 8).\n* Laboratory values at Screening of:\n\n  * Serum alanine transaminase (SGPT\u002FALT) \\\u003C 5 x upper limit of normal (ULN)\n  * Serum aspartate transaminase (SGOT\u002FAST) \\\u003C 5 x ULN\n  * Serum Bilirubin (total) \\\u003C 2.5 x ULN\n  * Serum Creatinine ≤ 1.5 x ULN\n* Weight ≥ 50kg\n\nExclusion Criteria:\n\n* Pregnant and nursing women\n* Concurrent anal, vulvar, or cervical cancer\n* HIV-positive participants with a CD4 count \\\u003C 200\n* Participants infected with HIV-1 if not on a stable, suppressive antiretroviral therapy (ART) regimen.\n* Unwillingness to undergo an excisional procedure at week 18 to either remove HSIL lesions, or to document histologic regression at a site where HSIL was present at study entry.\n* Currently receiving systemic chemotherapy or radiation therapy for another cancer.\n* Concomitant use of Efavirenz for HIV antiretroviral treatment\n* Concomitant use of strong UGT inhibitors\n* Concomitant use of imiquimod, cidofovir, or 5-fluorouracil (5-FU) for the duration of the study\n* Concurrent dermatological conditions affecting the vulva (e.g., herpetic lesion, Crohn's disease, hidradenitis suppurativa) or vulvar dermatoses (e.g., lichen sclerosis or planus, atopic dermatitis, genital atrophy).\n* Concurrent treatment with systemic corticosteroids","FEMALE","18 Years",{"count":20,"type":21},27,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","This is a phase II double-blind, placebo-controlled study of artesunate ointment for the treatment of HPV-associated vulvar HSIL (usual type vulvar intraepithelial neoplasia 2\u002F3).",[27,28,29,30,31,32,33,34,35,36,37,38,39],"Vulvar Diseases","HPV Infection","Vulvar HSIL","Pre-Cancerous Dysplasia","HPV Disease","VIN, Usual Type","VIN 2 of Usual Type","VIN 3 of Usual Type","Vin II","Vin III","VIN Grade 2","VIN Grade 3","High Grade Intraepithelial Neoplasia",[41,42,43,44,45,46,47,48,49],"topical treatment","ointment","non-surgical","vulvar cancer prevention","high-risk HPV","human papillomavirus","HPV","vulvar HSIL","High grade lesions","RECRUITING","2025-08-13",{"date":53,"type":54},"2025-08-14","ACTUAL",{"date":56,"type":54},"2023-12-06",{"date":58,"type":21},"2027-12",{"name":60,"class":61},"Frantz Viral Therapeutics, LLC","INDUSTRY",5,{"id":64,"slug":65,"hasResults":11,"nctId":66,"briefTitle":67,"officialTitle":68,"acronym":69,"eligibilityCriteria":70,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":71,"enrollmentInfo":72,"targetDuration":4,"studyType":22,"phases":74,"briefSummary":76,"conditions":77,"keywords":78,"overallStatus":81,"whyStopped":4,"lastUpdateSubmitDate":82,"lastUpdatePostDateStruct":83,"startDateStruct":85,"completionDateStruct":87,"leadSponsor":89,"locationsCount":92},"100520140","phase-4-adjuvant-nonavalent-hpv-vaccination-in-women-treated-for-vulvar-hsil-100520140","NCT06052696","Adjuvant Nonavalent HPV Vaccination in Women Treated for Vulvar HSIL","Adjuvant Nonavalent HPV Vaccination in Women Treated for Vulvar HSIL, a Randomised Placebo Controlled Trial","VulVaccin","Inclusion criteria\n\n* Women 18 years or older\n* Vulvar High-grade Squamous Intraepithelial Lesion (vHSIL), histologically proven\n* Planned for treatment (surgical, laser or imiquimod) for vHSIL\n\nExclusion criteria\n\n* Prior HPV vaccination\n* (Micro-) invasive carcinoma or history of HPV related genital carcinoma (cervix, anal, vulva)\n* Pregnancy\n* Women allergic to vaccine components\n* HIV infection\n* Immune compromised patients (currently on immunosuppressive medication","100 Years",{"count":73,"type":21},500,[75],"PHASE4","Problem description:\n\nYearly, approximately 45000 women develop vulvar cancer worldwide. It is estimated that about 30% of all vulvar carcinomas are HPV related. As with other HPV related (pre)malignancies, the incidence has been rising over the past 20 years. The peak incidence of premalignant lesions of the vulva, also called Vulvar High Grade Squamous Intraepithelial Lesion (vHSIL), lies between 35 and 40 years of age. Multiple treatments are available, including surgery, laser vaporization, and topical imiquimod, with comparable success rate. Despite treatment, at least 30% of women will develop a recurrence within 2 years, with a much higher lifetime risk of recurrence. This results in multiple treatments with sometimes disfiguring effects and associated negative psychosocial and psychosexual impact. Woman with vulvar HSIL have a lifelong increased risk of vulvar cancer, and approximately 10% of women with (treated) vulvar HSIL will develop vulvar cancer within 10 years of first diagnosis. The risk of malignancy is significantly higher in women with recurrent disease, compared to women without recurrence.\n\nSolution \u002F research direction, To date, a successful strategy for reduction of recurrences of HSIL has not been established. The available positive evidence on the use of concurrent HPV vaccination in the treatment of vulvar HSIL is rising, yet insufficient to guide clinical practice. There is limited data that prophylactic HPV vaccination after treatment of vulvar HSIL reduces the chance of recurrence, therefore leading to a reduction in repeated (surgical) interventions. There are no randomised controlled studies supporting this data.\n\nAim The aim of current project is to determine the effectiveness of nonavalent HPV vaccination versus placebo in preventing recurrence in women treated for vulvar HSIL.\n\nPlan of investigation This is a randomised, double blinded, placebo controlled trial in women treated for vulvar HSIL. Adult female patients, diagnosed with vulvar HSIL planned for treatment and no prior HPV vaccination will be included. Randomisation will be in a 1:1 ratio to additional nonavalent HPV vaccination versus additional placebo vaccination.\n\nExpected outcome. Based on previous non-randomised studies, a significant reduction in recurrences, improvement of quality of life and a reduction of economic burden of the disease is expected.",[29,47],[47,79,80],"VHSIL","Vaccination","NOT_YET_RECRUITING","2023-09-21",{"date":84,"type":54},"2023-09-25",{"date":86,"type":21},"2023-12-01",{"date":88,"type":21},"2030-12-01",{"name":90,"class":91},"Erasmus Medical Center","OTHER",1]