[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"wrinkles-such-as-nasolabial-folds\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:wrinkles-such-as-nasolabial-folds":32},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,1,0,[8],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":17,"sex":18,"minAge":19,"maxAge":20,"enrollmentInfo":21,"targetDuration":4,"studyType":24,"phases":25,"briefSummary":27,"conditions":28,"keywords":33,"overallStatus":43,"whyStopped":4,"lastUpdateSubmitDate":44,"lastUpdatePostDateStruct":45,"startDateStruct":48,"completionDateStruct":50,"leadSponsor":52,"locationsCount":5},"100606635","bridging-technique-validation-for-nasolabial-folds-jn-bridge-1-100606635",false,"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,"ALL","30 Years","65 Years",{"count":22,"type":23},60,"ESTIMATED","INTERVENTIONAL",[26],"NA","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.",[29,30,31,32],"Nasolabial Fold Correction","Facial Aging","Skin Rejuvenation","Wrinkles Such as Nasolabial Folds",[34,35,36,37,38,39,40,41,42],"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":46,"type":47},"2025-12-04","ACTUAL",{"date":49,"type":47},"2025-11-22",{"date":51,"type":23},"2026-11",{"name":53,"class":54},"Dr. Joseph M Novoa Libermann","OTHER"]