[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"nasolabial-fold-correction\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:nasolabial-fold-correction":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,44,83],{"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":28,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":32,"lastUpdatePostDateStruct":33,"startDateStruct":36,"completionDateStruct":38,"leadSponsor":40,"locationsCount":43},"100619324","to-evaluate-the-safety-and-efficacy-of-poly-l-lactic-acid-implants-for-the-correction-of-nasolabial-folds-100619324",false,"NCT07343141","To Evaluate the Safety and Efficacy of Poly-L-lactic Acid Implants for the Correction of Nasolabial Folds","A Prospective, Randomized, Evaluator\u002FSubject-blinded, Single-center, Split-Face Controlled Clinical Study: To Evaluate the Safety and Efficacy of Poly-L-lactic Acid Implants for the Correction of Nasolabial Folds","Inclusion Criteria:\n\n1. Willing and able to provide written informed consent prior to any study-specific procedures.\n2. Male or female subjects aged between 19 and 65 years.\n3. Presence of bilateral nasolabial fold wrinkles with a Wrinkle Severity Rating Scale (WSRS) score of moderate (Grade 3) or severe (Grade 4) at baseline.\n4. Willingness and ability to comply with all protocol-required follow-up visits and procedures.\n\nExclusion Criteria:\n\n1. History of hypertrophic scarring or keloid formation.\n2. Presence of active infection or dermatologic conditions at or near the intended injection site that may interfere with the evaluation.\n3. Underwent major surgery within 3 months prior to study initiation.\n4. Diagnosed with autoimmune diseases, malignancies, psychiatric disorders, or poorly controlled chronic medical conditions.\n5. Prior treatment with or planned use of permanent dermal fillers at the intended injection site.\n6. Prior treatment with or planned use of temporary fillers, collagen stimulators, or thread lifting at the injection site within 12 months prior to screening or during the study period.\n7. Underwent or plans to undergo laser treatments to the mid- or lower face within 3 months prior to treatment or during the study period.\n8. Underwent or plans to undergo ultrasound or radiofrequency skin tightening procedures to the mid- or lower face within 6 months prior to treatment or during the study period.\n9. Known hypersensitivity to poly-L-lactic acid or any components of the investigational device, or any other significant allergy as deemed by the investigator to pose risk to the subject.\n10. Planned surgeries or medications during the study period that may cause significant weight changes.\n11. Pregnant or breastfeeding women, or women intending to become pregnant during the study period.\n12. Participation in another interventional clinical trial that has not concluded within 30 days prior to screening, or plans to participate in another interventional clinical study during the course of this study.\n13. Any other condition or situation that, in the opinion of the investigator, renders the subject unsuitable for study participation.","ALL","19 Years","65 Years",{"count":20,"type":21},121,"ESTIMATED","INTERVENTIONAL",[24],"NA","The goal of this clinical trial is to evaluate the safety and effectiveness of a poly-L-lactic acid (PLLA) dermal implant for the correction of nasolabial folds. The study also aims to determine whether the investigational product (FUYANMEI Poly-L-Lactic Acid) is non-inferior to the control product (Sculptra).\n\nThe main questions it aims to answer are:\n\n* Is the effectiveness rate based on the Wrinkle Severity Rating Scale (WSRS) at 6 months after injection for the investigational group non-inferior to that of the control group?\n* How does the investigational product perform in terms of global aesthetic improvement as assessed by blinded evaluators and by subjects?\n* What is the safety profile of the investigational product, including the incidence, severity, and relatedness of adverse events (AEs), serious adverse events (SAEs), and device deficiencies (DDs)?\n\nResearchers will compare the investigational PLLA implant to an approved PLLA implant using a prospective, randomized, evaluator- and subject-blinded, single-center, split-face controlled study design. Approximately 121 eligible participants will be enrolled.\n\nParticipants will:\n\n* Receive treatment with the investigational product and the control product according to the split-face design\n* Be followed for 24 months after injection\n* Return to the clinic at 1, 3, 6, 12, 18, and 24 months post-injection for follow-up visits\n* Undergo blinded evaluator assessments of WSRS and Global Aesthetic Improvement Scale (GAIS)\n* Complete subject self-assessments of GAIS and treatment satisfaction\n* Be monitored throughout the study for adverse events, serious adverse events, and medical device deficiencies",[27],"Nasolabial Fold Correction",[29,30],"Poly-L-lactic Acid","Nasolabial folds","NOT_YET_RECRUITING","2026-05-21",{"date":34,"type":35},"2026-05-26","ACTUAL",{"date":37,"type":21},"2026-06-01",{"date":39,"type":21},"2028-03-31",{"name":41,"class":42},"SciVision Biotech Inc.","INDUSTRY",1,{"id":45,"slug":46,"hasResults":11,"nctId":47,"briefTitle":48,"officialTitle":49,"acronym":50,"eligibilityCriteria":51,"healthyVolunteers":52,"sex":16,"minAge":53,"maxAge":18,"enrollmentInfo":54,"targetDuration":4,"studyType":22,"phases":56,"briefSummary":57,"conditions":58,"keywords":62,"overallStatus":72,"whyStopped":4,"lastUpdateSubmitDate":73,"lastUpdatePostDateStruct":74,"startDateStruct":76,"completionDateStruct":78,"leadSponsor":80,"locationsCount":43},"100606635","bridging-technique-validation-for-nasolabial-folds-jn-bridge-1-100606635","NCT07178119","Bridging Technique Validation for Nasolabial Folds JN-BRIDGE-1","A Prospective Clinical Evaluation of the Bridging Technique Using AILEENE Vol. 2 Dermal Filler for the Treatment of Nasolabial Folds","BRIDGING","Inclusion Criteria\n\nAdults aged 30 to 65 years, inclusive, at the time of screening.\n\nMale or female, able and willing to comply with study procedures.\n\nPresence of visible bilateral nasolabial folds (NLF), each with a score of 2 or higher on the Nasolabial Fold Severity Scale (NLFSS), as assessed by the Principal Investigator.\n\nWilling to undergo facial dermal filler treatment using the Bridging Technique with AILEENE Vol. 2.\n\nIn generally good health, without uncontrolled chronic illness or active skin disease that could interfere with treatment or healing.\n\nAble to provide written informed consent and understand the nature and purpose of the study.\n\nWilling to refrain from undergoing any other facial cosmetic procedures (e.g., dermal fillers, botulinum toxin, laser, surgery, or radiofrequency) during the six-month study period.\n\nAgree to photographic documentation of the treatment area and follow-up assessments, and willing to allow use of anonymized photographs for blinded evaluation and publication.\n\nFor women of childbearing potential: negative urine pregnancy test at baseline.\n\nFemale participants of childbearing potential will undergo a urine pregnancy test on the day of treatment as a safety precaution, since there is insufficient evidence on filler safety during pregnancy.\n\nExclusion Criteria Presence of NLF graded less than 2 on the NLFSS on either side of the face.\n\nKnown allergy or hypersensitivity to hyaluronic acid (HA), lidocaine, or any component of AILEENE Vol. 2.\n\nHistory of severe allergic reactions, anaphylaxis, or allergy to local anesthetics.\n\nPrior use of dermal fillers, permanent implants, or other cosmetic procedures in the NLF area or lower face within the past 12 months.\n\nUse of botulinum toxin, chemical peels, laser, radiofrequency, or cryotherapy in the mid- or lower face within the last six months.\n\nActive skin infection, inflammation, herpes simplex (cold sore), acne, or other dermatologic condition in the treatment area.\n\nUse of topical medications such as retinoids or corticosteroids on the face within 30 days prior to treatment.\n\nCurrent or recent use (within 14 days) of anticoagulant, antiplatelet, or non-steroidal anti-inflammatory drugs (NSAIDs) that may increase the risk of bruising or bleeding.\n\nHistory of bleeding disorders.",true,"30 Years",{"count":55,"type":21},60,[24],"The goal of this clinical study is to learn whether the Bridging Technique can safely and effectively treat nasolabial folds (NLF, also known as smile lines) in adults. The main questions are:\n\nDoes the Bridging Technique, which places very small amounts of filler in thin horizontal threads (less than 0.05 milliliters \\[ml\\] per retrograde placement), improve the appearance of nasolabial folds?\n\nIs the treatment safe, and are participants satisfied with the results?\n\nThe Bridging Technique is a new method of filler injection where very small amounts of hyaluronic acid (HA) filler are placed in thin horizontal lines under the fold using a blunt cannula. These small \"bridges\" of filler act like internal support, helping to lift and soften the fold without overfilling or distorting the natural shape of the face.\n\nParticipants will:\n\nReceive an HA dermal filler (AILEENE Vol. 2) injected with the Bridging Technique to both nasolabial folds.\n\nAttend follow-up visits at Week 2 (virtual safety check), Week 4, Month 3, and Month 6.\n\nHave photographs taken at baseline, Week 4, Month 3, and Month 6, which will be reviewed by independent observers who are blinded to the visit sequence.\n\nComplete short questionnaires about their satisfaction and experience.\n\nThe study includes 60 adults aged 30 to 65 years. Each participant may receive up to 1.0 ml of filler in total across both folds. An optional top-up treatment may be offered at Week 2 or Week 4 if clinically indicated, using only the remaining balance of the total 1.0 ml allowance. Any top-up will be performed with a new, sterile syringe, not with filler physically left over from the first visit. There is no cost to participants, and participation is voluntary.",[27,59,60,61],"Facial Aging","Skin Rejuvenation","Wrinkles Such as Nasolabial Folds",[63,64,65,66,67,68,69,70,71],"Hyaluronic Acid Filler","Dermal Filler","AILEENE Vol. 2","Bridging Technique","Minimally Invasive Aesthetics","Non-Surgical Facial Rejuvenation","Wrinkle Correction","Global Aesthetic Improvement Scale (GAIS)","Nasolabial Fold Severity Scale (NLFSS)","RECRUITING","2025-12-03",{"date":75,"type":35},"2025-12-04",{"date":77,"type":35},"2025-11-22",{"date":79,"type":21},"2026-11",{"name":81,"class":82},"Dr. Joseph M Novoa Libermann","OTHER",{"id":84,"slug":85,"hasResults":11,"nctId":86,"briefTitle":87,"officialTitle":88,"acronym":4,"eligibilityCriteria":89,"healthyVolunteers":11,"sex":16,"minAge":90,"maxAge":4,"enrollmentInfo":91,"targetDuration":4,"studyType":22,"phases":93,"briefSummary":94,"conditions":95,"keywords":96,"overallStatus":31,"whyStopped":4,"lastUpdateSubmitDate":98,"lastUpdatePostDateStruct":99,"startDateStruct":101,"completionDateStruct":103,"leadSponsor":105,"locationsCount":4},"100589979","a-study-in-adults-evaluating-polycaprolactone-microsphere-filler-for-treatment-of-moderate-to-severe-nasolabial-folds-100589979","NCT06961448","A Study in Adults Evaluating Polycaprolactone Microsphere Filler for Treatment of Moderate to Severe Nasolabial Folds","A Prospective, Multi-center, Evaluator-blinded, Randomized, Parallel-controlled, Superiority Clinical Trial to Evaluate the Safety and Efficacy of Polycaprolactone Microsphere Fillers for Correction of Moderate to Severe Nasolabial Folds","Inclusion Criteria:\n\n1. Aged 18 or above, with no gender restriction.\n2. Willing to receive treatment for correcting nasolabial fold.\n3. Treatment investigator evaluate those with a WSRS score of 3 or 4 for bilateral nasolabial folds;\n4. Willing to voluntarily participate in the clinical trial, accepting the obligation not toreceive all plastic surgery and cosmetic dermatology procedures or treatments during the trial。 Willing and able to undergo the required treatment and follow-up observations, and sign the informed consent form.\n\nExclusion Criteria:\n\n1. Allergy to polycaprolactone, hyaluronic acid products or any component of the investigational device or control device(such as streptococcal proteins), allergy to any local anesthetic (such as lidocaine or other amide-typeanesthetic), or history of severe allergic reactions and multiple severe allergic reactions.\n2. Previous surgery, cosmetic facial procedure, or plans to undergo cosmetic surgery in NLF area or lower face during the trial, inculding any of the following circumstances:\n\n   1. Received permanent fillers or prostheses (such as PMMA etc.) or semi-permanent dermal fillers (such as CaHA, PLLA, PCL, etc.).\n   2. Received temporary dermal fillers (such as HA and collagen etc.) within 12 months prior to screening.\n   3. Received anti-wrinkle surgery within 12 months prior to screening.\n   4. Receiving botulinum toxin injection, chemical stripping, radiofrequency laser, and liquid nitrogen freezing anti-wrinkle treatment within 6 months.\n3. Individuals who used topical agents (e.g., corticosteroids, steroids \\[excluding hydrocortisone\\], retinoids, or retinoid derivatives intended as medications but not as cosmetics) on the mid-to-lower facial area within 3 months prior to screening or plan to use them during the trial period, as well as those undergoing hydrocortisone treatment.\n4. Individuals with abnormal coagulation mechanisms \\[activated partial thromboplastin time (APTT) \\>1.5 times the upper limit of normal (ULN), etc.\\], or use of anticoagulants (e.g., warfarin, rivaroxaban), antiplatelet agents (e.g., aspirin, clopidogrel), thrombolytic agents (e.g., recombinant human urokinase) within 2 weeks prior to screening.\n5. Individuals with severe liver or kidney dysfunction, such as liver function markers (ALT, AST) exceeding 2 times the ULN or kidney function markers (creatinine) exceeding 1.5 times the ULN.\n6. Individuals with infectious diseases, including any positive test results for hepatitis B surface antigen, hepatitis C antibodies, HIV antibodies, or syphilis antibodies.\n7. Individuals with scars, unhealed wounds, deformities, defects, tattoos, or excessive pigmentation in the nasolabial fold area that may affect the efficacy assessment.\n8. Individuals with tumors, precancerous lesions, active skin lesions such as herpes, in the nasolabial fold area.\n9. Individuals with acute or chronic skin diseases such as infections or inflammation in the treatment area.\n10. Individuals with autoimmune diseases, such as psoriasis.\n11. Individuals with uncontrolled diabetets.\n12. Individuals prone to scarring, keloid formation, or hypertrophic scars.\n13. Individuals diagnosed with psychiatric disorders, lacking self-autonomy, or experiencing active episodes of anxiety or depression.\n14. Individuals with excessively high expectations of treatment outcomes or unwilling to accept potential short-term side effects such as bruising, swelling, or pain.\n15. Individuals who are pregnant, breastfeeding, or unwilling to use medically approved contraception (e.g., oral contraceptives, condoms, intrauterine devices) during the trial.\n16. Individuals who participated in other drug or medical device clinical trials within 3 months prior to screening.\n17. Individuals deemed unsuitable for trial participation by the investigator for other reasons.","18 Years",{"count":92,"type":21},208,[24],"The goal of this clinical trial is to evaluate the safety and efficacy of polycaprolactone microsphere filler (Lafullen) for the correction of moderate to severe nasolabial folds in adults aged 18 and above, regardless of gender.\n\nThe main questions it aims to answer are:\n\n* Does Lafullen improve wrinkle severity in the nasolabial fold area at 48 weeks post-injection (WSRS responder rate)?\n* Is Lafullen superior to the control product (Restylane, a hyaluronic acid filler) in terms of long-term wrinkle correction and safety? Researchers will compare Lafullen (polycaprolactone filler) with Restylane (modified sodium hyaluronate gel) to see if Lafullen provides superior wrinkle correction at 12 months post-injection.\n\nParticipants will:\n\n* Receive either Lafullen or Restylane via injection in the nasolabial fold area.\n* Optionally receive a touch-up injection at 4 weeks after the first treatment if needed.\n* Undergo regular follow-up visits at 4, 12, 24, 36, and 48 weeks post-treatment.\n* Subjects in the Lafullen group will continue follow-up up to 72 weeks to assess long-term efficacy and safety.\n* Be assessed through clinical photography, pain scale (VAS), satisfaction questionnaires, and safety evaluations (e.g., AEs, vital signs, lab tests).",[27],[97,30],"Polycaprolactone microsphere filler","2025-04-29",{"date":100,"type":35},"2025-05-08",{"date":102,"type":21},"2025-05-01",{"date":104,"type":21},"2026-11-01",{"name":106,"class":42},"Samyang Biopharmaceuticals Corporation"]