[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100484241":3},{"organization":4,"armGroups":7,"interventions":23,"overallOfficials":34,"centralContacts":39,"locations":29,"responsibleParty":44,"collaborators":46,"id":52,"slug":53,"hasResults":54,"nctId":55,"briefTitle":56,"officialTitle":57,"acronym":29,"eligibilityCriteria":58,"healthyVolunteers":54,"sex":59,"minAge":60,"maxAge":61,"enrollmentInfo":62,"targetDuration":29,"studyType":65,"phases":66,"briefSummary":68,"conditions":69,"keywords":72,"overallStatus":77,"whyStopped":29,"lastUpdateSubmitDate":78,"lastUpdatePostDateStruct":79,"startDateStruct":82,"completionDateStruct":84,"leadSponsor":86,"locationsCount":29},{"fullName":5,"class":6},"Instituto de Investigación Sanitaria de la Fundación Jiménez Díaz","OTHER",[8,15,19],{"label":9,"type":10,"description":11,"interventionNames":12},"Laser + Regenerative topical treatment","EXPERIMENTAL","The treatments used in this arm are the following:\n\n1. º Microfractionated laser treatment of C02, through the AcupulseDuo generator of the company Lumenis®. The treatment regimen would consist of three sessions in total with periodicity of 4 weeks, between the first and the second, and 6 weeks between the second and third. The application of laser energy will be carried out by vaginal and vulvar terminals. The dose applied will consist of monopulse shots distributed throughout the vaginal mucosa and vulvar skin of 10 mJ of energy and at a density of 10%.\n2. nd Topical treatment: It consists of the application of XCM® intim of the company Mucosa Innovations. The route of administration would be vulvo-vaginal. The dose applied would be 2 ml of total product every 12 hours during 36 months.",[13,14],"Device: C02 microablative laser","Combination Product: Regenerative topical treatment",{"label":16,"type":10,"description":17,"interventionNames":18},"Regenerative topical treatment","In this arm, only the regenerative treatment of XCM® intim of the company Mucosa Innovations will be used. The route of administration would be vulvo-vaginal. The dose applied would be 2 ml of total product every 12 hours. The total duration of treatment would be 36 months.",[14],{"label":20,"type":10,"description":21,"interventionNames":22},"Laser treatment","The treatments used in this arm are the following:\n\n1. º Microfractionated laser treatment of C02, through the AcupulseDuo generator of the company Lumenis®. The treatment regimen would consist of three sessions in total with periodicity of 4 weeks, between the first and the second, and 6 weeks between the second and third. The application of laser energy will be carried out by vaginal and vulvar terminals. The dose applied will consist of monopulse shots distributed throughout the vaginal mucosa and vulvar skin of 10 mJ of energy and at a density of 10%.\n2. ºPlacebo vulvo-vaginal topical gel, consisting of a watery base.",[13],[24,30],{"type":25,"name":26,"description":27,"armGroupLabels":28,"otherNames":29},"DEVICE","C02 microablative laser","The C02 microablative laser was the first to be used in the treatment of menopausal genitourinary syndrome. Its mechanism of action is based on the emission of light at a wavelength of 10600nm that is absorbed by the water molecules contained in the vaginal mucosa, leading to local remodeling of connective tissue and neoformation of collagen, elastic fibers and other components of the extracellular matrix.",[9,20],null,{"type":31,"name":16,"description":32,"armGroupLabels":33,"otherNames":29},"COMBINATION_PRODUCT","It is a moisturizing and regenerating gel whose active ingredients are olive oil, trimethylglycine and xylitol.",[9,16],[35],{"name":36,"affiliation":37,"role":38},"Amalia Cañadas Molina","Employee","PRINCIPAL_INVESTIGATOR",[40],{"name":36,"role":41,"phone":42,"phoneExt":29,"email":43},"CONTACT","+34 653422973","amalia.canadas@fjd.es",{"type":45,"investigatorFullName":29,"investigatorTitle":29,"investigatorAffiliation":29,"oldNameTitle":29,"oldOrganization":29},"SPONSOR",[47,50],{"name":48,"class":49},"Lumenis Be Ltd.","INDUSTRY",{"name":51,"class":49},"Mucosa Innovations, S.L.","100484241","a-laser-and-topical-treatment-combination-in-the-vulvo-vaginal-atrophy-management-in-breast-cancer-patients-100484241",false,"NCT05585476","A Laser and Topical Treatment Combination in the Vulvo-vaginal Atrophy Management in Breast Cancer Patients.","Effectiveness of C02 Microfractionated Laser in Conjunction With Topical Regenerative Therapy in the Management of Vulvo-vaginal Atrophy in Patients With a History of Breast Cancer. Randomized Experimental and Comparative Study.","Inclusion Criteria:\n\nPatients must meet ALL of the following criteria to be included in the study:\n\n1. Patients over 18 years of age\n2. Who have a history of breast malignancy, and are on adjuvant or neoadjuvant treatment with hormone therapy.\n3. That they suffer symptoms related to vulvo-vaginal atrophy and thus become evident to the gynecological examination (Vaginal Health Index\\\u003Có=15).\n4. That this clinic significantly affects your quality of life ( score in Sexual Function-Vaginal Changes Questionnaire less than or equal to 24 points).\n5. Who have not received any treatment for vulvo-vaginal atrophy in at least the previous 6 months. Purely moisturizing or emollient treatments that do not contain any regenerating substance (hyaluronic acid, gotu kola, vitamin E or rosehip oil) are not considered exclusive.\n6. That they agree to participate and give their written I consent.\n\nExclusion Criteria:\n\nPatients who present ANY of the following criteria may not be selected to participate in this study:\n\n1. Medical or surgical history that at the discretion of the researcher does not allow participation in the study.\n2. Refusal to participate in the study and to sign consent.\n3. Be on chemotherapy treatment at the time of inclusion in the study.\n4. Have completely completed the adjuvant hormonal treatment.\n5. Have a history of vulvar, vaginal and\u002For cervical malignancy.\n6. Have received radiation therapy to the pelvic and\u002For genital region.\n7. Sjögren's syndrome and other pathologies that occur with mucosal involvement.\n8. Present any type of disease that occurs with alteration of collagenogenesis.\n9. Intake of other cytotoxic drugs that lead to mucositis and alterations of tissue regeneration in the last 6 months.\n10. Have previously received laser and\u002For radiofrequency treatment for the treatment of genital atrophy or other pelvic floor dysfunctions.\n11. Active urinary and\u002For genital tract infection.\n12. Diagnosis of gestation at the time of recruitment.\n13. History of malignant neoplasm of the urinary tract.\n14. Have severe stress urinary incontinence (Sandvik test with a score equal to or greater than 8)\n15. Diagnosis of pelvic organ prolapse grade III or higher according to the POP-Q classification.\n16. Any other condition which, in the opinion of the investigator, means that the patient is not in a position to understand the implication of participating in the study and\u002For of following the established procedures.","FEMALE","18 Years","100 Years",{"count":63,"type":64},180,"ESTIMATED","INTERVENTIONAL",[67],"NA","The genito-urinary syndrome of menopause severely affects patients with a history of gynecological cancer, especially those diagnosed with breast cancer. At the present time, we do not have solid scientific evidence on treatments that can be effective and safe to address this pathology. Based on the above, we have developed our working hypothesis where it is postulated that the microfractionated laser treatment of C02, in conjunction with topical regenerative treatment, constitute an effective alternative in the management of vulvo-vaginal atrophy in oncological patients who have contraindicated hormonal treatments.",[70,71],"Female Urogenital Diseases","Breast Cancer Female",[73,74,75,16,76],"Vulvovaginal atrophy","Breast cancer","Hormone therapy","C02 microfractionated laser","NOT_YET_RECRUITING","2025-09-15",{"date":80,"type":81},"2025-09-19","ACTUAL",{"date":83,"type":64},"2025-10",{"date":85,"type":64},"2026-09",{"name":5,"class":6}]