A prospective, open‐label, multicentric, single‐arm, post‐marketing clinical study to evaluate effectiveness and safety of Cross‐Linked Sodium Hyaluronate 24mg with Lidocaine 3mg Injection in subjects undergoing treatment for facial wrinkles and lip augmentation
Abstract:Background
Hyaluronic acid (HA) fillers are quite commonly used since several years for soft tissue augmentation.
Aim
The purpose of this study was to evaluate primarily the safety and secondarily the clinical effectiveness of Cross‐Linked Sodium Hyaluronate 24 mg with Lidocaine 3 mg (Jeunesso 24L) injection, in subjects undergoing treatment for facial wrinkles and lip augmentation.
Method
Patients between the age groups of 18 and 75 years, who were seeking soft tissue augmentation treatment on the face and wi… Show more
“…Most studies addressing the efficacy and longevity of lip filler injection have used subjective evaluation measures such as patient satisfaction surveys and physician observation [ 5 , 24 ]. Validated photonumeric lip fullness scales have also been used to objectively compare lip augmentation results in several clinical studies [ 24 , 25 , 26 , 27 ]. However, only a few studies [ 13 , 14 ] have used quantitative measurements to assess the volume enhancement effects of lip filler injections.…”
The study aimed to compare the volume enhancement and the lifting capacity of two different hyaluronic acid gels for lip injection. Thirty-six Korean female patients were randomized into two groups according to the cross-linking degree of the hyaluronic acid filler injected. Using a fixed injection protocol, patients were injected with 1 mL of hyaluronic acid filler in the lips and followed up at four and 12 weeks after injection. Lip volume, lip projection, and columella–labial angle were measured using a 3-dimensional imaging system at each time point. Follow-up values were compared with baseline. Compared with pre-treatment values, there was a statistically significant increase in mean lip volume and lip projection at four and 12 weeks after injection, with no significant differences between the two groups. Lips injected with hyaluronic acid filler of intermediate cross-link density resulted in more acute angles than lips injected with lightly cross-linked hyaluronic acid. The difference was statistically significant at each follow-up time point. No serious complications were observed throughout the study period. Our results imply that in patients who want a prominent upper lip lift, lip injections using hyaluronic acid fillers with intermediate cross-linking density can be a good option due to their lift capacity. The degree of cross-linking may not be a significant determinant of simple lip volume augmentation when other variables are constant.
“…Most studies addressing the efficacy and longevity of lip filler injection have used subjective evaluation measures such as patient satisfaction surveys and physician observation [ 5 , 24 ]. Validated photonumeric lip fullness scales have also been used to objectively compare lip augmentation results in several clinical studies [ 24 , 25 , 26 , 27 ]. However, only a few studies [ 13 , 14 ] have used quantitative measurements to assess the volume enhancement effects of lip filler injections.…”
The study aimed to compare the volume enhancement and the lifting capacity of two different hyaluronic acid gels for lip injection. Thirty-six Korean female patients were randomized into two groups according to the cross-linking degree of the hyaluronic acid filler injected. Using a fixed injection protocol, patients were injected with 1 mL of hyaluronic acid filler in the lips and followed up at four and 12 weeks after injection. Lip volume, lip projection, and columella–labial angle were measured using a 3-dimensional imaging system at each time point. Follow-up values were compared with baseline. Compared with pre-treatment values, there was a statistically significant increase in mean lip volume and lip projection at four and 12 weeks after injection, with no significant differences between the two groups. Lips injected with hyaluronic acid filler of intermediate cross-link density resulted in more acute angles than lips injected with lightly cross-linked hyaluronic acid. The difference was statistically significant at each follow-up time point. No serious complications were observed throughout the study period. Our results imply that in patients who want a prominent upper lip lift, lip injections using hyaluronic acid fillers with intermediate cross-linking density can be a good option due to their lift capacity. The degree of cross-linking may not be a significant determinant of simple lip volume augmentation when other variables are constant.
Background: One of the most challenging areas for facial rejuvenation is the lower eyelid. Apart from the protruding orbital fat causing lower lid bags, a discrete entity called the "tear trough deformity" is distinguishable in this area.
Aim:The objective of this study is to compare and evaluate the standard technique of tear trough deformity correction with the lateral injection technique using a high G prime filler to establish a guideline for the safe and effective correction of tear trough deformity.
Methods: A prospective, double-blind, study was carried out from Dec 2017 to 2019 including 30 participants in the age range of 35-60 years. The participants were divided into two groups of 15 patients each. In group A patients, conventional technique with a low G Prime filler was used, whereas in group B, lateral injection technique with a high G Prime filler was used.Results: Marked improvement was seen in appearance and skin quality on both the sides in all the patients. As compared to our technique (lateral injections) where a mean of 0.5 ml of filler was used to lift the cheek and reduce the tear trough, the standard technique (Mauricio de Maio's 3-point tear trough reshape technique) required a mean of 1.2 ml of filler for the same. Post-procedure complications including bruising and Tyndall effect were much higher (statistically significant) using the standard medial technique for the correction tear trough.
Conclusion:Aesthetically satisfying results for the tear trough correction are possible, without actually injecting the tear trough directly, based on the knowledge of the underlying anatomy.
K E Y W O R D Sdermal filler, high G prime filler, lateral injection technique, tear trough treatment, under eye dark circle treatment How to cite this article: Vadera S, Shome D, Kumar V, Doshi K, Kapoor R. Innovative approach for tear trough deformity correction using higher G prime fillers for safe, efficacious, and long-lasting results: A prospective interventional study. J
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