Safety and Effectiveness of Juvéderm Ultra Plus Injectable Gel in Correcting Severe Nasolabial Folds in Chinese Subjects

Dong, Li; Xie, Yun; Qin, Li; Sun, Jiaming; Jiang, Ping; Jia, Yi; Murphy, Diane K.; Li, Qingfeng

doi:10.1097/gox.0000000000001133

Cited by 15 publications

(19 citation statements)

References 16 publications

(22 reference statements)

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“…The performance of RES and PER for NLF correction is well established on the basis of extensive investigations in split-face designed, randomized controlled studies. 26 , 27 In such studies, WSRS responder rates for the correction of NLFs at 6 months after treatment have ranged from approximately 70%–85% with RES and 63%–88% with PER, 26 – 30 while those were comparatively low in our studies, 56.14% with RES and 48.15% with PER. This difference between studies may be the result of differences in the timing of touchup treatment and/or the total volume injected into the NLFs.…”

Section: Discussioncontrasting

confidence: 51%

“…Although our studies were conducted in an Asian population, there have been no reported differences in the performance or safety of RES/PER used for NLF correction in Asian and non-Asian populations. 27 , 29 , 30 We therefore expect that YC and YV will have similar risk–benefit profiles when used for NLF correction in Asian and non-Asian ethnic groups.…”

Section: Discussionmentioning

confidence: 99%

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Two Randomized Controlled Trials of Hyaluronic Acid Fillers for the Correction of Nasolabial Folds

Yang

Shin

Lee

2020

Plastic and Reconstructive Surgery - Global Open

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Background: YVOIRE Classic s (YC) and Restylane (RES) have similar rheological properties, which suit mid-dermis injection, while the rheological properties of YVOIRE Volume s (YV) are comparable to those of Perlane (PER), which suit deep dermis injection to treat deep wrinkles. Two similarly designed studies aimed to evaluate the performance and safety of YC and YV injected into the nasolabial folds (NLFs). Methods: These were split-face designed, evaluator-blind, noninferiority studies. Fifty-eight subjects with moderate-to-severe NLFs were enrolled in the first study and treated with YC and RES, and 57 subjects were enrolled in the second study and treated with YV and PER. The Wrinkle Severity Rating Scale ranged from 1 (no visible fold) to 5 (extremely deep and long folds), and subject satisfaction was evaluated. Results: The least squares mean Wrinkle Severity Rating Scale scores (standard error) at week 26 were 2.56 (0.09) for both YC- and RES-treated NLFs and 2.89 (0.08) and 2.91 (0.08) for YV- and PER-treated NLFs, respectively. The difference between the groups was 0 and 0.02, and the lower limit of its 95% confidence interval was −0.0725 and −0.0125, which was greater than the predefined margin (−0.29), proving the noninferiority of YC and YV to RES and PER, respectively. The safety profiles and subject satisfaction of YC and YV were similar to those of RES and PER, respectively. Conclusion: YC is comparable to RES and YV is comparable to PER in terms of performance and safety profiles, with NLF-correcting effects lasting for up to 26 weeks.

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Section: Discussioncontrasting

confidence: 51%

Section: Discussionmentioning

confidence: 99%

Two Randomized Controlled Trials of Hyaluronic Acid Fillers for the Correction of Nasolabial Folds

Yang

Shin

Lee

2020

Plastic and Reconstructive Surgery - Global Open

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“…The volume injected was chosen by the investigator and depended on the depth of NLF to be corrected. Median volumes used in the current investigation were similar to volumes used in the RL efficacy study in Chinese subjects for correction of severe NLFs (1.00 mL) 10,11…”

Section: Discussionmentioning

confidence: 54%

Safety and effectiveness of hyaluronic acid dermal filler in correction of moderate-to-severe nasolabial folds in Chinese subjects

Dai

Peterson

et al. 2019

CCID

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BackgroundModified sodium hyaluronate gel for injection, Princess® VOLUME (PV), has been on the European market since 2009 to correct deeper wrinkles and folds, increasing or restoring volume of the face, and remodeling facial contours.ObjectiveTo evaluate the safety and effectiveness of PV in correction of moderate-to-severe nasolabial folds (NLF) in Chinese subjects.MethodsIn this prospective, split-face, randomized, evaluator and subject-blinded, multicenter, noninferiority trial, 120 subjects were randomized to bilateral NLF treatment with PV administered in one NLF and Restylane® (RL) administered in the other NLF. NLFs were evaluated using the validated 5-point Wrinkle Severity Rating Scale with scores ranging from 1= none (no visible NLF) to 5= very severe (extremely deep and long NLF). Response was defined as ≥1 point improvement at Week 24 assessed by the blinded independent review committee (IRC) and the reduction of NLF severity, assessed by subjects and IRC based on the Global Aesthetic Improvement Scale.ResultsAmong the 115 subjects who completed the study, median initial and touch-up volumes (mL) were 1.00 for both groups with a maximum dosage per NLF of 2.00 and a minimum of 0.30 for PV and 0.60 for RL. At week 24, the Wrinkle Severity Rating Scale improvement rate, as assessed by the IRC, reached 68.70% for PV and 52.17% for RL. The results indicate that PV is noninferior to RL (p<0.001). Most frequently reported adverse events for both devices were injection site swelling and procedural pain. The severity of the majority of the adverse events was mild.ConclusionThis study confirms that PV is a safe and effective treatment for the correction of moderate-to-severe NLFs in Chinese subjects.

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“…The percentage of greater than mild incidents = (16/1800) × 100 = 8.8%. In contrast, the incidence of greater than mild adverse events for Juvederm has been reported at 25%, 82%, and 29.9% and for Restylane at 96.3% and 43.1% …”

Section: Discussionmentioning

confidence: 99%

A multi‐center, open‐label, pilot study of allograft adipose matrix for the correction of atrophic temples

Gold

Kinney

Kaminer

et al. 2020

J of Cosmetic Dermatology

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Background Autologous fat grafting (AFG) and synthetic fillers are currently used in esthetic and reconstructive surgery. Challenges in AFG include inconsistent graft retention, donor site morbidities, insufficient harvest, and excessive harvesting times. An allograft adipose matrix (AAM) has been developed as an off‐the‐shelf alternative to AFG and synthetic fillers. Aims To evaluate the clinical safety and retention of an AAM over 24 weeks after treatment of bilateral atrophic temples. Patients/Methods Ten subjects (nine females, one male, aged 47‐69 years) with temple atrophy were enrolled in the IRB‐approved study. AAM (Renuva®, MTF Biologics, Edison, NJ) was injected (<3 mL) bilaterally into the atrophic temples of each subject. Volume retention, global improvement, and safety were evaluated at 1, 4, 8, 12, 16, 20, and 24 weeks. Biopsy specimens were obtained for adipogenic and angiogenic histological evaluation. Results The mean temple volume improved over the baseline and was retained throughout the study period. Fullness (measure of volume) increased immediately from 0 pretreatment to 2.8 post‐treatment (scale 0‐4 = none‐maximum). Fullness varied from 0.8 to 2.2 from weeks 1 through 12 and was 2.7‐3.0 from weeks 16‐24, around 75% increase from baseline. Furthermore, skin tone, smoothness, texture, and overall appearance also improved with 71% of subjects being satisfied to very satisfied with the results. Adverse events were minimal and histology revealed native tissue incorporation and remodeling. Conclusion AAM is safe and well tolerated, provides at least 6‐month volume retention, improves skin quality, and supports adipose tissue remodeling after treatment into temples.

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Safety and Effectiveness of Juvéderm Ultra Plus Injectable Gel in Correcting Severe Nasolabial Folds in Chinese Subjects

Cited by 15 publications

References 16 publications

Two Randomized Controlled Trials of Hyaluronic Acid Fillers for the Correction of Nasolabial Folds

Two Randomized Controlled Trials of Hyaluronic Acid Fillers for the Correction of Nasolabial Folds

Safety and effectiveness of hyaluronic acid dermal filler in correction of moderate-to-severe nasolabial folds in Chinese subjects

A multi‐center, open‐label, pilot study of allograft adipose matrix for the correction of atrophic temples

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