{"title":"Prospective Clinical Evaluation of Cross-Linked Hyaluronic Acid Dermal Filler (30 mg) for Facial Rejuvenation.","authors":"Debraj Shome, Devendra Khalsa, Bhargav Joshi, Depti Bellani, Ashwin Prabhughate, Alivia Basu, Atrey Pai Khot, Rinky Kapoor","doi":"10.1097/GOX.0000000000007149","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Cross-linked hyaluronic acid dermal fillers are being used increasingly for aesthetic enhancements, including lip enhancement, cheekbone augmentation, and nasolabial fold improvement. This study aimed to assess the safety and performance of a newly introduced dermal filler across different skin types.</p><p><strong>Methods: </strong>This is a prospective, single-arm clinical study that evaluates the safety and effectiveness of cross-linked sodium hyaluronate injection in patients undergoing treatment for facial wrinkles and lip enhancement. Participants underwent assessments at baseline; immediately at postoperative day 0; and at 3 months, 6 months, and 1 year after the procedure. The safety and effectiveness were evaluated through physical examinations, wrinkle severity ratings, full face global aesthetic assessments, cheekbone augmentation, nasolabial fold severity, and lip enhancement evaluations.</p><p><strong>Results: </strong>The study cohort included 122 participants, 41 men and 81 women, predominantly with Fitzpatrick skin types 3 (59%) and 4 (41%). Physical examinations revealed a significant reduction in facial wrinkles, with 81.14% (left side) and 84.42% (right side) of patients showing no wrinkles after 1 year. Full face aesthetic improvements were noted, with 36.88% of patients being \"very much improved.\" Cheekbone augmentation showed no wrinkles in 55.74% of patients (left side) and 72.13% (right side) at 1 year. Nasolabial fold severity decreased most significantly between 6 months and 1 year.</p><p><strong>Conclusions: </strong>The novel cross-linked hyaluronic acid dermal filler is safe and effective for enhancing lips, augmenting cheekbones, and improving nasolabial folds across various skin types. Significant improvements were observed in wrinkle severity, overall facial aesthetics, and specific enhancement areas.</p>","PeriodicalId":20149,"journal":{"name":"Plastic and Reconstructive Surgery Global Open","volume":"13 10","pages":"e7149"},"PeriodicalIF":1.8000,"publicationDate":"2025-10-03","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12494042/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Plastic and Reconstructive Surgery Global Open","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.1097/GOX.0000000000007149","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/10/1 0:00:00","PubModel":"eCollection","JCR":"Q3","JCRName":"SURGERY","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Cross-linked hyaluronic acid dermal fillers are being used increasingly for aesthetic enhancements, including lip enhancement, cheekbone augmentation, and nasolabial fold improvement. This study aimed to assess the safety and performance of a newly introduced dermal filler across different skin types.
Methods: This is a prospective, single-arm clinical study that evaluates the safety and effectiveness of cross-linked sodium hyaluronate injection in patients undergoing treatment for facial wrinkles and lip enhancement. Participants underwent assessments at baseline; immediately at postoperative day 0; and at 3 months, 6 months, and 1 year after the procedure. The safety and effectiveness were evaluated through physical examinations, wrinkle severity ratings, full face global aesthetic assessments, cheekbone augmentation, nasolabial fold severity, and lip enhancement evaluations.
Results: The study cohort included 122 participants, 41 men and 81 women, predominantly with Fitzpatrick skin types 3 (59%) and 4 (41%). Physical examinations revealed a significant reduction in facial wrinkles, with 81.14% (left side) and 84.42% (right side) of patients showing no wrinkles after 1 year. Full face aesthetic improvements were noted, with 36.88% of patients being "very much improved." Cheekbone augmentation showed no wrinkles in 55.74% of patients (left side) and 72.13% (right side) at 1 year. Nasolabial fold severity decreased most significantly between 6 months and 1 year.
Conclusions: The novel cross-linked hyaluronic acid dermal filler is safe and effective for enhancing lips, augmenting cheekbones, and improving nasolabial folds across various skin types. Significant improvements were observed in wrinkle severity, overall facial aesthetics, and specific enhancement areas.
期刊介绍：
Plastic and Reconstructive Surgery—Global Open is an open access, peer reviewed, international journal focusing on global plastic and reconstructive surgery.Plastic and Reconstructive Surgery—Global Open publishes on all areas of plastic and reconstructive surgery, including basic science/experimental studies pertinent to the field and also clinical articles on such topics as: breast reconstruction, head and neck surgery, pediatric and craniofacial surgery, hand and microsurgery, wound healing, and cosmetic and aesthetic surgery. Clinical studies, experimental articles, ideas and innovations, and techniques and case reports are all welcome article types. Manuscript submission is open to all surgeons, researchers, and other health care providers world-wide who wish to communicate their research results on topics related to plastic and reconstructive surgery. Furthermore, Plastic and Reconstructive Surgery—Global Open, a complimentary journal to Plastic and Reconstructive Surgery, provides an open access venue for the publication of those research studies sponsored by private and public funding agencies that require open access publication of study results. Its mission is to disseminate high quality, peer reviewed research in plastic and reconstructive surgery to the widest possible global audience, through an open access platform. As an open access journal, Plastic and Reconstructive Surgery—Global Open offers its content for free to any viewer. Authors of articles retain their copyright to the materials published. Additionally, Plastic and Reconstructive Surgery—Global Open provides rapid review and publication of accepted papers.
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