[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"dermal-fillers\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:dermal-fillers":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,61],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":40,"overallStatus":48,"whyStopped":4,"lastUpdateSubmitDate":49,"lastUpdatePostDateStruct":50,"startDateStruct":53,"completionDateStruct":55,"leadSponsor":57,"locationsCount":60},"100593584","impact-of-nipple-reconstruction-in-mastectomized-patients-using-cross-linked-hyaluronic-acid-injection-100593584",false,"NCT07008339","Impact of Nipple Reconstruction in Mastectomized Patients Using Cross-Linked Hyaluronic Acid Injection.","RECHIAL","* Quantitative Phase\n* Inclusion Criteria:\n\nWomen over 18 years of age, or with parental or legal guardian consent.\n\nAt least one of the following criteria:\n\nWomen undergoing their first nipple-areola complex (NAC) reconstruction through micropigmentation and\u002For:\n\nNo previous neo-nipple surgery, either unilaterally or bilaterally.\n\nSurgical reconstruction of the areola.\n\nSurgical reconstruction of the NAC with subsequent retraction of the neo-nipple.\n\nMore than 6 months since their last surgery.\n\n\\- Exclusion Criteria:\n\nAllergy to hyaluronic acid.\n\nPoor tolerance to needle injections.\n\nWithdrawal Criteria:\n\nParticipant's voluntary decision.\n\nComplications associated with the technique (allergy, hematoma, etc.).\n\nClinical deterioration preventing the woman from continuing in the study.\n\n\\- Qualitative Phase\n\nParticipant Profile Characteristics: For the qualitative phase, women who have received NAC reconstruction with HA will be invited to participate, following the maximum variation criterion. To ensure the inclusion of participants with diverse characteristics and capture a wide range of perspectives and experiences on the phenomenon under study, women of varying ages, with different breast cancer diagnoses, and histories of various oncological, surgical, and therapeutic treatments will be selected.","FEMALE","18 Years",{"count":19,"type":20},138,"ESTIMATED","INTERVENTIONAL",[23],"NA","This study evaluates the impact of hyaluronic acid (HA) injection for nipple projection following mastectomy, as a complement to areola micropigmentation. While micropigmentation is standard in nipple-areola complex (NAC) reconstruction, HA use remains novel, with limited data on psychosocial, sexual, and aesthetic outcomes.\n\nA sequential explanatory mixed-methods design will be used. In Phase 1, a randomized controlled trial will compare two groups: one receiving NAC micropigmentation alone (control) and the other receiving micropigmentation plus HA-based nipple projection (intervention). A total of 138 participants will be recruited at the Areolar Micropigmentation Unit of Germans Trias i Pujol University Hospital (Barcelona) over 36 months. Outcomes will include psychosocial and sexual well-being, satisfaction with breast and nipple appearance, and nipple projection, measured using the Spanish BREAST-Q, a custom satisfaction tool, and calipers.\n\nPhase 2 will involve a qualitative phenomenological study using semi-structured interviews with a purposive sample from the intervention group. Thematic analysis will explore body image, emotional and social well-being, and overall satisfaction, using NVivo software.\n\nThis is the first study assessing HA nipple reconstruction by advanced practice nurses using validated patient-reported outcomes. While the BREAST-Q is appropriate, it may not fully capture emotional nuances, justifying qualitative exploration. HA durability is estimated at 6-9 months, but residual volume and satisfaction over time remain underexplored. HA's aesthetic footprint may allow reduced dosages in future applications.\n\nThis minimally invasive technique may reduce the need for surgical nipple reconstruction. Conducting the procedure in a nurse-led setting is novel and may enhance patient-centered care and the role of nursing in post-mastectomy recovery.\n\nThe study complies with the Declaration of Helsinki and Spanish biomedical regulations. Ethical approval was obtained. Participants will provide informed consent, and data will be anonymized and securely stored.",[26,27,28,29,30,31,32,33,34,35,36,37,38,39],"Breast Neoplasms","Mastectomy","Mammaplasty","Nipple Disorder","Tattooing","Hyaluronic Acid","Dermal Fillers","Reconstructive Surgical Procedures","Quality of Life","Self Concept","Body Image","Patient Satisfaction","Breast Reconstruction","Nipple Reconstruction",[41,27,38,42,39,43,31,32,44,30,36,34,45,46,37,47],"Breast Cancer","Nipple-Areola Complex Reconstruction","Areola Reconstruction","Micropigmentation","Postmastectomy Reconstruction","Cross-linked Hyaluronic Acid","Breast Cancer Survivors","RECRUITING","2025-06-04",{"date":51,"type":52},"2025-06-06","ACTUAL",{"date":54,"type":52},"2023-06-02",{"date":56,"type":20},"2029-07-02",{"name":58,"class":59},"Germans Trias i Pujol Hospital","OTHER",1,{"id":62,"slug":63,"hasResults":11,"nctId":64,"briefTitle":65,"officialTitle":66,"acronym":67,"eligibilityCriteria":68,"healthyVolunteers":69,"sex":70,"minAge":71,"maxAge":72,"enrollmentInfo":73,"targetDuration":4,"studyType":21,"phases":75,"briefSummary":77,"conditions":78,"keywords":80,"overallStatus":82,"whyStopped":4,"lastUpdateSubmitDate":83,"lastUpdatePostDateStruct":84,"startDateStruct":86,"completionDateStruct":88,"leadSponsor":90,"locationsCount":60},"100584164","phase-2-purpose-of-this-study-is-the-demonstration-of-safety-and-efficacy-of-the-dermal-fillers-dxp01-temporary-improvement-of-moderate-to-severe-nasolabial-folds-100584164","NCT06885775","Purpose of This Study is the Demonstration of Safety and Efficacy of the Dermal Fillers DXP01 Temporary Improvement of Moderate to Severe Nasolabial Folds","A Multicenter, Randomized, Evaluator- and Subject-blinded, Active-controlled, Paired, Confirmatory Clinical Trial to Compare and Evaluate the Efficacy and Safety of DXP01 Versus Juvéderm® ULTRA 3 in Adults Requiring the Temporary Improvement of Moderate to Severe Nasolabial Folds","DXP01","Inclusion Criteria:\n\n1. Males and females aged 19 to 70 years.\n2. Subjects with nasolabial folds (NLF) on both sides scored at 3 or 4 on the WSRS (Wrinkle Severity Rating Scale) as evaluated by the investigator at screening (both sides do not need to have the same score but must fall within the 3-4 range).\n3. Subjects with visually symmetrical nasolabial folds (NLF) on both sides.\n4. Subjects who can comply with the clinical trial procedures and will not undergo any facial cosmetic procedures\u002Fsurgeries contraindicated for combination therapy during the clinical trial.\n5. Males and females of childbearing potential who agree to use medically accepted contraception\\* during the clinical trial period. (\\*Hormonal contraception, intrauterine device (IUD) or intrauterine system (IUS), tubal ligation, double-barrier methods (such as combining cervical cap or diaphragm with male condom), or single-barrier methods combined with spermicide).\n6. Subjects who have received a detailed explanation of this clinical trial, understand it, voluntarily decide to participate, and provide written consent.\n7. For women of childbearing potential, individuals who test negative for pregnancy prior to the administration of the investigational product.\n\nExclusion Criteria:\n\n1. Subjects with localized wounds or active infections (such as cysts, acne, rashes, hives, etc.) in the nasolabial fold area.\n2. Subjects with acute, chronic, or recurrent skin conditions (whether infectious or non-infectious).\n3. Subjects with scars or abnormal skin findings (such as moles, erythema, or telangiectasia) in the nasolabial fold area that may affect treatment outcomes.\n4. Subjects with a history of keloid formation, hyperpigmentation, or hypertrophic scars.\n5. Subjects with a history of bleeding disorders (such as liver disease, clotting factor deficiencies, etc.).\n6. Subjects with a history of herpetic rash.\n7. Subjects with connective tissue diseases, autoimmune diseases, or suspected immune deficiencies (such as Sjögren's syndrome, systemic lupus erythematosus, etc.).\n8. Subjects with active sepsis, sarcoidosis, infective endocarditis, or confirmed infections regardless of location, type, or size.\n9. Subjects with known allergies or hypersensitivity reactions, either localized or systemic, to the components of the investigational medical device or amide-type local anesthetics.\n10. Subjects who tested positive in skin patch tests for either the investigational device or control device.\n11. Subjects with a significant history of allergies or anaphylaxis that could affect this clinical trial.\n12. Subjects with clinically significant disorders in the cardiovascular, gastrointestinal, respiratory, endocrine, or central nervous systems.\n13. Subjects with a history of malignancy within 5 years of screening (except for those with basal cell carcinoma, squamous cell carcinoma of the skin, carcinoma in situ of the cervix, thyroid cancer, or prostate cancer, provided there has been no recurrence for over 3 years after complete remission, as judged by the investigator).\n14. Subjects suffering from untreated epilepsy.\n15. Subjects suffering from porphyria.\n16. Subjects with a history of alcohol or drug addiction.\n17. Subjects with a history of psychiatric disorders that, in the investigator's opinion, could significantly affect this clinical trial.\n18. Subjects who have undergone cosmetic procedures contraindicated for this clinical trial within 24 weeks of screening (except for upper eyelid surgery, rhinoplasty performed more than 24 months postoperatively, or lower eyelid correction).\n19. Subjects who have undergone skin augmentation or permanent\u002Fsemi-permanent implant-based cosmetic surgery (such as fillers based on CaHA, PLLA, PMMA, etc.) or PCL fillers or HA fillers on the face within 12 months of screening - CaHA (calcium hydroxyl apatite), PLLA (poly L-lactide), PMMA (polymethyl methacrylate), PCL (polycaprolactone), HA (Hyaluronic Acid)\n20. Subjects who have taken any of the following medications within 1 week before the application of the investigational medical device or who are scheduled to take them within 3 days after application (however, if the medication is being taken at the time of screening and, in the investigator's judgment, a temporary discontinuation does not pose a medical risk, the individual may participate in the clinical trial after a 10-day wash-out period): \\*Anticoagulants, antiplatelet agents, thrombolytics (e.g., warfarin), oral\u002Finjectable corticosteroids, nonsteroidal anti-inflammatory drugs (NSAIDs) (low-dose aspirin up to 300 mg\u002Fday is permitted), and substances that delay blood coagulation time (such as vitamin E preparations of 400 IU\u002Fday or more, including multivitamins, garlic, and ginkgo biloba extracts).\n21. Subjects who have received systemic corticosteroids or immune-suppressants within 12 weeks of screening.\n22. Subjects who have applied oral or topical preparations or cosmetics with anti-wrinkle effects to the facial area within 12 weeks of screening (however, the use of sunscreen and certain cosmetics such as alpha hydroxyl acids, glycolic acids, retinol, or retinoic acids, which have been continuously used for more than 90 days prior to screening, is permitted).\n23. Subjects who have undergone chemotherapy within 12 weeks of screening.\n24. Subjects who have received botulinum toxin injections in the face within 24 weeks of screening.\n25. Subjects who have taken other investigational drugs or had investigational medical devices applied within 4 weeks of screening.\n26. Pregnant women, women planning to become pregnant during the clinical trial period, or breastfeeding women.\n27. Subjects who, for any other reason, are deemed unsuitable by the investigator for inclusion in this clinical trial.",true,"ALL","19 Years","70 Years",{"count":74,"type":20},80,[76],"PHASE2","Purpose of this study is the demonstration of safety and efficacy of the dermal fillers DXP01 Face for restoration of moderate to severe nasolabial folds",[32,79],"Nasolabial Folds, Wrinkles",[81,67],"NASOLABIAL FOLDS","NOT_YET_RECRUITING","2025-03-13",{"date":85,"type":52},"2025-03-20",{"date":87,"type":20},"2025-04-28",{"date":89,"type":20},"2027-12-01",{"name":91,"class":92},"DEXLEVO","INDUSTRY"]