[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"cin---cervical-intraepithelial-neoplasia\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:cin---cervical-intraepithelial-neoplasia":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,48],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":4,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":18,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":32,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":36,"lastUpdatePostDateStruct":37,"startDateStruct":40,"completionDateStruct":42,"leadSponsor":44,"locationsCount":47},"100591342","a-clinical-trial-to-investigate-the-safety-and-efficacy-of-papillex-on-abnormal-cervical-cells-caused-by-hpv-100591342",false,"NCT06979180","A Clinical Trial to Investigate the Safety and Efficacy of Papillex® on Abnormal Cervical Cells Caused by HPV.","A Randomized, Triple-blind, Placebo-controlled, Parallel Clinical Trial to Investigate the Safety and Efficacy of Papillex® on Abnormal Cervical Cells Caused by HPV","Inclusion Criteria:\n\n1. Females between 25 and 55 years of age\n2. Females not of child-bearing potential, defined as those who have undergone a permanent sterilization procedure (e.g. hysterectomy, bilateral oophorectomy or bilateral tubal occlusion) or have been post-menopausal for at least 1 year prior to screening Or,\n\n   Individuals of child-bearing potential must have a negative baseline urine pregnancy test and agree to use a medically approved method of birth control for the duration of the study. All hormonal birth control must have been in use for a minimum of three months. Acceptable methods of birth control include:\n   * Hormonal contraceptives including oral contraceptives, hormone birth control patch (Ortho Evra), vaginal contraceptive ring (NuvaRing), injectable contraceptives (Depo-Provera, Lunelle), hormone implant (Norplant System) or intrauterine hormone-releasing system\n   * Double-barrier method\n   * Intrauterine devices\n   * Non-heterosexual lifestyle or agrees to use contraception if planning on changing to heterosexual partner(s)\n   * Vasectomized partner, provided that partner is the sole sexual partner and that the vasectomised partner has received medical assessment of the surgical success\n   * Abstinence\n3. Histologically confirmed CIN1+ (as per standard of care) with concordant hrHPV positivity at that time, and current abnormal cytology and hrHPV positivity at screening; interval between historical diagnosis and screening must be \\>12 months OR documented abnormal cytology (LSIL or worse) plus hrHPV positive \\>12 months prior, and current abnormal cytology with hrHPV positivity at screening\n4. Willing to provide copies of histology and\u002For cytology reports for eligibility confirmation\n5. Agrees to maintain current lifestyle habits (diet, physical activity, medications, supplements, and sleep) as much as possible throughout the study\n6. Willingness to avoid magnetic resonance imaging, computed tomography, X-ray, or other procedures with contrast media injection for 48 hr prior to study visits assessing micronutrient status\n7. Willingness and ability to complete questionnaires and diaries associated with the study, and to complete all clinic visits and assessments\n8. Provided voluntary, written, informed consent to participate in the study\n9. Otherwise healthy as determined by medical history and laboratory results as assessed by Qualified Investigator (QI)\n\nExclusion Criteria:\n\n1. Women who are pregnant, breast feeding, or planning to become pregnant during the study\n2. Allergy, sensitivity, or intolerance preventing consumption of investigational product or placebo ingredients\n3. Currently undergoing treatment for CIN, are indicated for treatment during the study period, have received treatment (e.g., conization or loop electrosurgical excision procedure) within the last five years, or have active CIN 3\n4. Concurrent uterine pathologies\n5. History of hysterectomy or destructive therapy of the cervix\n6. Cervical cancer\n7. Unstable metabolic disease or chronic diseases as assessed by the QI\n8. Current or history of any significant diseases of the gastrointestinal tract as assessed by the QI\n9. Unstable hypertension. Treatment on a stable dose of medication for at least 3 months will be considered by the QI (See Section 7.3)\n10. Significant cardiovascular event in the past 6 months. Participants with no significant cardiovascular event on stable medication may be included after assessment by the QI on a case-by-case basis\n11. History of or current diagnosis with kidney and\u002For liver diseases as assessed by the QI on a case-by-case basis, with the exception of history of kidney stones in participants who are symptom free for 6 months\n12. Self-reported confirmation of current or pre-existing thyroid condition. Treatment on a stable dose of medication for at least 3 months will be considered by the QI\n13. Major surgery in the past 3 months or individuals who have planned surgery during the course of the study. Participants with minor surgery will be considered on a case-by-case basis by the QI\n14. Cancer, except skin basal cell carcinoma completely excised with no chemotherapy or radiation with a follow up that is negative. Volunteers with cancer in full remission for more than five years after diagnosis are acceptable\n15. Individuals with an autoimmune disease or are immune compromised\n16. Self-reported confirmation of a HIV-, Hepatitis B- and\u002For C-positive diagnosis as assessed by the QI\n17. Self-reported confirmation of blood\u002Fbleeding disorders as assessed by the QI\n18. Alcohol intake average of \\>2 standard drinks per day as assessed by the QI\n19. Alcohol or drug abuse within the last 12 months\n20. Current use of prescribed and\u002For over-the-counter (OTC) medications, supplements, and\u002For consumption of food\u002Fdrinks that may impact the efficacy and\u002For safety of the investigational product (Section 7.3)\n21. Clinically significant abnormal laboratory results at screening as assessed by the QI\n22. Blood donation 30 days prior to baseline, during the study, or a planned donation within 30 days of the last study visit\n23. Participation in other clinical research studies 30 days prior to baseline, as assessed by the QI\n24. Individuals who are cognitively impaired and\u002For who are unable to give informed consent\n25. Any other condition or lifestyle factor, that, in the opinion of the QI, may adversely affect the participant's ability to complete the study or its measures or pose significant risk to the participant","FEMALE","25 Years","55 Years",{"count":20,"type":21},60,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to investigate the safety and efficacy of Papillex® on the regression of abnormal cervical cells caused by HPV in women with a cervical intraepithelial neoplasia (CIN) 1 or 2 diagnosis. The main question it aims to answer is:\n\nIs there a difference in the proportion of participants with a regression in CIN based on histology or cytology from baseline at day 180 between Papillex® and placebo?\n\nParticipants will be asked to consume Papillex® or placebo for 180 days, complete questionnaires, a PAP smear, HPV test, and colonoscopy (where applicable).",[27,28,29,30,31],"CIN - Cervical Intraepithelial Neoplasia","CIN 1","CIN 2","HPV","Cervical Cells",[33,30,34],"Cervical intraepithelial neoplasia","Papillex","RECRUITING","2026-03-03",{"date":38,"type":39},"2026-03-05","ACTUAL",{"date":41,"type":21},"2026-03",{"date":43,"type":21},"2026-12",{"name":45,"class":46},"Papillex Inc.","INDUSTRY",1,{"id":49,"slug":50,"hasResults":11,"nctId":51,"briefTitle":52,"officialTitle":53,"acronym":54,"eligibilityCriteria":55,"healthyVolunteers":11,"sex":16,"minAge":56,"maxAge":4,"enrollmentInfo":57,"targetDuration":4,"studyType":59,"phases":4,"briefSummary":60,"conditions":61,"keywords":4,"overallStatus":35,"whyStopped":4,"lastUpdateSubmitDate":63,"lastUpdatePostDateStruct":64,"startDateStruct":66,"completionDateStruct":68,"leadSponsor":70,"locationsCount":47},"100582345","multiple-human-papillomavirus-infections-in-the-development-of-cin-100582345","NCT06862102","Multiple Human Papillomavirus Infections in the Development of CIN","Prospective Clinical Study on the Role of Multiple Human Papillomavirus Infections in Lower Genital Tract Dysplasias and Its Interactions with HPV Vaccination","HPV dysplasia","Inclusion Criteria:\n\n* Pap smear cytology suggestive of dysplastic cervical lesion worthy of colposcopic evaluation and HPV test\n* HPV-related vaginal and\u002For vulvar lesion\n* patients with histological diagnosis after biopsy of Cervical Intraepithelial Neoplasia (CIN) or invasive cervical cancer of stage lower than FIGO staging 1B.\n\nExclusion Criteria:\n\n* pregnancy\n* age less than 18 years\n* previous treatment for HPV-related vaginal, vulvar or cervical lesion in the previous 5 years","18 Years",{"count":58,"type":21},152,"OBSERVATIONAL","Multiple infections of high-risk genotypes of Human Papillomavirus (HR-HPV) in patients with abnormal cervical cytological or histological findings are detectable in a percentage ranging from 20% to 50% of cases.\n\nSome studies have detected a certain tendency to specific clustering in multiple infections, both inter-species and inter-genotypic, such as HPV 31-35-56, HPV 16-51-52, HPV 16-18, HPV 51-52. Furthermore, a greater tendency of the HPV16 genotype to cluster with genotypes of different species is reported in the literature. However, other studies claim a random character of such genotypic associations in multiple infections. This heterogeneity of results of the studies present in the literature underlies multiple factors, both epidemiological and methodological, implicated in the high variability of prevalence and diagnostic findings of multiple infections. In particular, with regard to epidemiological characteristics, factors influencing the distribution of multiple infections appear to be the origin and type of population, economic-social status, young age, HIV seropositivity and recent sexual activity. A further hypothesized element is represented by a possible individual susceptibility dictated by the immune profile of the host towards specific genotypes, potentially facilitating the occurrence of co-infections by these, possibly resulting in a synergistic effect on the oncogenic potential. From a clinical point of view, to date multiple cross-sectional studies suggest an association between multiple infections of HR-HPVs and an increased risk of high-grade cervical dysplasia. In particular, a proportional relationship is observed between the number of genotypes present and the severity of the lesion. Furthermore, it has been reported that the correlation between multiple HR-HPV infections and severe cervical dysplasia CIN2+ is significant both in the presence and absence of the known oncogenic genotype HPV16, assuming a possible synergistic interaction between specific high-risk genotypes. However, other studies seem to refute the clinical relevance of multiple infections in the risk of neoplastic progression of cervical lesions, mostly claiming the precept of \"one virus, one lesion\", such that each dysplastic lesion is associated with the action of a distinct HR-HPV genotype. In this assumption, therefore, it is argued that moderate-severe cervical dysplasias are due to the action of a single oncogenic genotype, predominantly HPV16, while the presence of other HR-HPVs is attributable to transient infections, mostly represented by mild dysplasias (CIN1). As far as biological knowledge is concerned, in vitro studies currently demonstrate how it is possible for a single cell to be co-infected by at least two HR-HPV genotypes and how this can result in peculiar inter-genotypic molecular interactions that influence the replication cycle and the respective capacity for cellular persistence and transformation of the individual genotypes involved. The inter-genotypic competition mechanisms detected, therefore, occur mostly during the initial phases of acute infection by the HR-HPVs involved. However, it has been demonstrated that when a persistent infection of a genotype has already been established, this is no longer able to negatively interact with a subsequent incident infection by a different HR-HPV genotype. This finding in the biological field is consistent with the clinical correlate according to which the association between multiple HR-HPV infections and the risk of high-grade cervical dysplasia is greater when these are established on a pre-existing persistent infection. Therefore, it is conceivable that there is a higher rate of genotype-specific association in multiple HR-HPV infections found in cervical dysplastic lesions, defined by the peculiar capacities of the individual genotypes to give rise to persistent cellular infections. Despite the proven efficacy of vaccination programs in preventing cervical dysplastic lesions and infection by the main viral genotypes with high oncogenic risk, numerous studies demonstrate the clinical efficacy of HPV vaccination also in reducing the rate of disease recurrence in patients undergoing excisional treatment. A first explanatory hypothesis of this phenomenon is represented by the protection that the vaccination procedure would provide to those patients not previously infected by the target HR-HPV genotypes, potentially causative of de novo infections with high oncogenic risk. A further hypothesis under study is represented by the fact that the administration of the HPV vaccine following excisional treatment would prevent the reduction of the immune response against HPV.",[27,30,62],"HPV Vaccines","2025-03-06",{"date":65,"type":39},"2025-03-10",{"date":67,"type":39},"2021-01-08",{"date":69,"type":21},"2028-12-31",{"name":71,"class":72},"Fondazione IRCCS Policlinico San Matteo di Pavia","OTHER"]