Plastic and reconstructive surgery. Global open · 2025
Prospective Clinical Evaluation of Cross-Linked Hyaluronic Acid Dermal Filler (30 mg) for Facial Rejuvenation.
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Shome Debraj, Khalsa Devendra, Joshi Bhargav, Bellani Depti, Prabhughate Ashwin, Basu Alivia, Pai Khot Atrey, Kapoor Rinky
Аннотация
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.
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.