Biphasic Hyaluronic Acid Filler Research Articles

Comparison of the efficacy and safety between a new monophasic hyaluronic acid filler and a biphasic hyaluronic acid filler in correcting facial wrinkles

Background The longstanding and common use of hyaluronic acid (HA) has driven the expanded development of various commercial HA fillers. However, differences in the components of these HA fillers lead to variations in their effect. We compared the <i>in vivo</i> safety and efficacy of biphasic HA (BHA) and a new monophasic HA (MHA) for improving facial wrinkles. We investigated differences in outcomes after their injection into nasolabial folds (NLFs) using the Wrinkle Severity Rating Scale (WSRS), patient satisfaction using the Global Aesthetic Improvement Scale (GAIS), and pain using a visual analog scale (VAS). We also performed a safety assessment of the two fillers.Methods This matched-pair, double-blind, randomized study compared the degree of temporal wrinkle improvement in the NLFs of 91 participants using the BHA filler versus the new MHA filler. Safety and efficacy were compared at 8 and 24 weeks.Results At 24 weeks after application, the average WSRS scores were 2.17±0.72 (BHA) and 2.07±0.71 (MHA) (P=0.034). The average GAIS scores, as measured by a treating investigator at 8 weeks and 24 weeks, were 0.94±0.76 (BHA) and 0.98±0.78 (MHA) at 8 weeks (P=0.181), and 0.44±0.64 (BHA) and 0.49±0.69 (MHA) at 24 weeks (P=0.103). The VAS pain score was 0 points at 30 minutes after filler application in both groups.Conclusions Both the BHA filler and the new MHA filler were safe and effective for improving facial wrinkles in NLFs, but the new MHA filler was more effective for the cosmetic improvement of wrinkle severity than the BHA filler.

Monophasic and Biphasic Hyaluronic Acid Fillers for Esthetic Correction of Nasolabial Folds: A Meta-Analysis of Randomized Controlled Trials.

Hyaluronic acid (HA) fillers have become the most popular dermal fillers for esthetic nasolabial folds (NLFs) correction. Based on the cross-linking method, they can be classified as monophasic or biphasic types. The aim of this meta-analysis is to compare the efficacy and safety of monophasic HA fillers with that of biphasic HA fillers for treatment of NLFs. PubMed, Embase, Cochrane Library, Web of Science, ClinicalTrials.gov, and Chinese databases were searched from inception to January 2021. Randomized controlled trials (RCTs) that compared treatment outcomes of a monophasic HA filler with a biphasic HA filler for esthetic NLF correction were selected. Twenty-two RCTs with totally 1848 subjects were included to this meta-analysis. A significantly higher improvement of NLF severity score was seen for monophasic fillers than biphasic fillers at 2 (p = 0.005), 8 (p <0.0001), 12 (p = 0.03), 16 (p = 0.005), 24 (p <0.00001), 36 (p = 0.007), and 52 week (p <0.0001) after treatment. The effect was retained regardless of ethnicity, total injection volume, and baseline NLF severity. More subjects preferred monophasic fillers over biphasic ones (≤7 months: RR = 3.45, 95% CI 1.17 to 10.11; >7 months: RR = 2.37, 95% CI 1.45 to 3.86). Rate of post-injection pain was significantly lower for monophasic fillers (RR = 0.85, 95% CI 0.78 to 0.92, p <0.0001), but no statistical difference was observed for other post-injection adverse events. Compared to biphasic HA fillers, monophasic HA fillers were associated with a greater and more durable esthetic NLFs improvement, a lower rate of post-injection pain, and were favored by more patients. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

A Single-Center, Randomized, Double-Blind Clinical Trial to Compare the Efficacy and Safety of a New Monophasic Hyaluronic Acid Filler and Biphasic Filler in Correcting Nasolabial Fold.

Hyaluronic acid (HA) fillers have been widely used in humans since 1958 because of their biomedical safety. Restylane® was introduced in the1990s as a favorable temporary filler option for facial augmentation. Subsequently, many new HA filler products, including the Sardenyashape®, have been introduced, but comparative studies of these products are limited. Here, we compared tolerability (wrinkle severity rating scale, WSRS), pain (visual analog scale, VAS score), satisfaction (global esthetic improvement scale, GAIS), and safety of a new monophasic HA (MHA) filler (Sardenyashape®) containing lidocaine, used to correct nasolabial folds (NLFs), with those of biphasic HA (BHA) filler (Restylane LYFT®) containing lidocaine. We enrolled 96 participants with visible NLFs in this randomized, double-blind, single-center clinical study. Participants were injected with a new MHA filler in one NLF and a BHA filler and were reassessed for cosmetic changes at 8 and 24 weeks. Wrinkle severity was assessed using the 5-point WSRS. At week 24, the mean improvement in WSRS compared to baseline was 1.92 ± 0.75 and 2.24 ± 0.66 for MHA and BHA fillers, respectively, and corresponding average pain values using the VAS score 30min after the procedure were 0.04 ± 0.25 and 0.02 ± 0.15, respectively, showing no significant difference. Average GAIS values 8 weeks after the procedure with MHA and BHA fillers were 1.89 ± 0.77 and 1.40 ± 0.82, respectively (p < 0.001). Both fillers were well tolerated, with mild adverse reactions. The evaluation of the effect of Sardenyashape® with lidocaine on NLF in this study proved its effectiveness and safety for use in correcting NLF. This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266 .

A comparison of the safety, efficacy, and longevity of two different hyaluronic acid fillers in filler rhinoplasty: A multicenter study.

Filler rhinoplasty is a popular procedure in Asia, and it is of great importance to understand the clinical efficacy and durability of the different filler products that serve this purpose. Here, we aimed to evaluate and compare the safety, efficacy, and longevity of two different hyaluronic acid (HA) fillers in improving the nasal profile in Asians. A multicenter comparative trial was performed for 48 weeks after a single injection of a popular monophasic monodensified, and a newly developed biphasic HA filler. Assessments including patient satisfaction and three-dimensional (3D) imaging analysis were performed before, immediately after, 2 weeks, 12 weeks, 24 weeks, and 48 weeks after filler rhinoplasty. Twenty-eight Korean women underwent structured rhinoplasty were divided into monophasic monodensified (n = 14) and biphasic (n = 14) groups. There were significant changes in the facial profile following filler rhinoplasty throughout the study period. Overall, an increase of 1.75 mm in nose height, increase of 3.66° in the nasofrontal angle and 2.77° in the nasolabial angle, and radix elevation of 1.24 mm was noted at week 48 which was statistically different from the baseline values (P < .05). Between the different filler types, statistical difference was only noted in radix elevation (per milliliter of filler material) immediately after filler injection. No serious adverse event occurred during treatment or follow-up. Nonsurgical rhinoplasty with the specific HA filler products led to significant changes in the facial profile which persisted for 48 weeks. Overall, the clinical efficacy and safety were comparable between the two filler types except for radix elevation which was more prominent with C-C immediately after filler injection. J-V was superior to C-C in maintaining the radix elevation long term.

Ex vivo magnetic resonance imaging using hyaluronic acid fillers: Differences between monophasic and biphasic fillers.

Hyaluronic acid (HA) is an anionic, non-sulfated glycosaminoglycan distributed throughout the human skin and injectable HA fillers are the most commonly used in aesthetic field. This study aimed to determine if differences in physical characteristics of HA products (monophasic or biphasic fillers) affect the patterns of magnetic resonance imaging (MRI). Twenty biphasic fillers and nine monophasic fillers were obtained from a commercial source, and examined with a 3.0Tesla MRI scanner. Visual assessments and measurements of signal intensity for region of interest (ROI) were performed. A non-parametric Wilcoxon rank sum test was used to compare the ROI values. Visual assessments by a radiologist did not show significant differences between the two types of fillers. While the signal intensity between the two types of filler did not differ significantly for T1-weighted images, the signal intensity of the biphasic filler was lower than that of the monophasic filler for T2-weighted images (P<.01). Monophasic and biphasic HA fillers exhibited different MRI properties. Our findings may provide better insights into the use of in vivo MRI to evaluate aesthetic, procedure-related complications.

Effect of molecular weight of hyaluronic acid (HA) on viscoelasticity and particle texturing feel of HA dermal biphasic fillers.

BackgroundHyaluronic acid (HA) dermal biphasic fillers are synthesized for their efficacy in correcting aesthetic defects such as wrinkles, scars and facial contouring defects. The fillers consist of crosslinked HA microspheres suspended in a noncrosslinked HA. To extend the duration of HAs within the dermis and obtain the particle texturing feel, HAs are crosslinked to obtain the suitable mechanical properties.ResultsHyaluronic acid (HA) dermal biphasic fillers are prepared by mixing the crosslinked HA microspheres and the noncrosslinked HAs. The elastic modulus of the fillers increased with raising the volume fraction of the microspheres. The mechanical properties and the particle texturing feel of the fillers made from crosslinked HA (1058 kDa) microspheres suspended in noncrosslinked HA (1368 kDa) are successfully achieved, which are adequate for the fillers.ConclusionsDermal biphasic HA fillers made from 1058 kDa exhibit suitable elastic moduli (211 to 420 Pa) and particle texturing feel (scale 7 ~ 9).

Efficacy and safety of a new monophasic hyaluronic acid filler in the correction of nasolabial folds: a randomized, evaluator-blinded, split-face study

Background: Hyaluronic acid (HA) fillers are frequently used for the correction of facial soft-tissue defects. Objective:To compare the efficacy and safety of a novel monophasic HA filler (mono-HA), and a well-studied biphasic HA filler (bi-HA), in the treatment of moderate to severe nasolabial folds. Methods: In this randomized, evaluator-blinded, split-face comparative study, subjects were randomized for injections with mono-HA or bi-HA on the left or right side of the face. Efficacy was determined by calculating the change in the Wrinkle Severity Rating Score (WSRS) relative to baseline. Local safety was assessed on the basis of subject diary entries which recorded erythema, swelling, induration, pruritus, irritation, mass, hematoma, pain, and dryness. Results: At week 24, the mean improvement in the WSRS from baseline was 2.18 ± 0.42 for the mono-HA side and 2.16 ± 0.41 for the bi-HA side. Both fillers were well-tolerated and adverse reactions were mild and transient in most cases. Conclusions: Mono-HA has a non-inferior efficacy to bi-HA in the treatment of moderate to severe nasolabial folds.

Efficacy, Safety, and Patient Satisfaction of a Monophasic Cohesive Polydensified Matrix Versus a Biphasic Nonanimal Stabilized Hyaluronic Acid Filler After Single Injection in Nasolabial Folds

Intradermal injection of hyaluronic acid (HA) is currently the criterion standard to reduce the appearance of nasolabial folds (NLF). Effects of a monophasic HA filler using cohesive polydensified matrix (CPM) technology were compared with those of nonanimal stabilized HA (NASHA). In a double-blind, half-side comparison, 20 subjects (ages 35-65, mean 52±5.6) with symmetric NLF grade 3 to 4 were randomized to contralateral treatment with a monophasic polydensified filler (CPM) and a biphasic HA filler (NASHA). Efficacy was assessed at baseline and after 2, 24, and 48weeks using a wrinkle severity rating scale (WSRS) for NLF, subject questionnaire, and biophysical in vivo methods. All subjects showed significant improvements with both fillers up to day 365. Subject questionnaires confirmed significantly less injection pain for the CPMHA, significantly greater patient satisfaction after 2weeks with both fillers, and after 24 and 48weeks significantly greater improvement with the CPMHA compared to baseline. WSRS and skin surface topography parameters improved significantly up to 48weeks with both fillers. A single intradermal injection of a monophasic CPMHA and a biphasic NASHA filler showed significant improvements in WSRS and measured wrinkle depth up to 48weeks for both fillers and significant differences in injection comfort and patient satisfaction in favor of CPMHA.

Comparative study of hyaluronic acid fillers by in vitro and in vivo testing

Numerous hyaluronic acid (HA) fillers seem to have similar characteristics, although manufacturers insist that monophasic and biphasic HA fillers are different in many ways. Little information regarding this is available in the literature. To determine characteristics of monophasic fillers vs. biphasic fillers. We tested three different (two biphasic and one monophasic) HA fillers both in vitro and in vivo. In the in vitro assay, cell toxicity, resistance to enzyme degradation, syringeability and morphology of particles were tested. In vivo, the efficacy and safety were investigated in the dorsal skin of hairless mice. There was no cell toxicity in any of the three HA fillers. Resistance to enzymatic degradation and syringeability were better in the two biphasic HA fillers than in the monophasic filler. In particle morphology test, gel type monophasic HA filler was also found as a particle type, although there was a slight difference. Volume assessment in animal skin was superior with the monophasic than with the two biphasic HA fillers. Biphasic HA fillers have some advantages in hyaluronidase resistance, syringeability and lower risk for overcorrection, while monophasic HA fillers may be more suitable for volume augmentation due to swelling capacity.

Efficacy and Durability of Two Hyaluronic Acid-Based Fillers in the Correction of Nasolabial Folds: Results of a Prospective, Randomized, Double-Blind, Actively Controlled Clinical Pilot Study

This pilot study compared a monophasic hyaluronic acid dermal filler with a biphasic filler for the correction of nasolabial folds. Participant- and assessor-blinded, randomized clinical trial involving participants with moderate to severe nasolabial folds. Split-face design comparing a monophase hyaluronic acid (HA) filler (mono-HA) with a biphasic HA filler (bi-HA). Injection with touch-up after 1 month. Wrinkle improvement was measured before and after injection and after 1, 2, 4, and 7 months, using the Wrinkle Severity Rating Scale and the Global Aesthetic Improvement Scale as outcome criteria. An optional treatment was offered at the end of the study, with participants allowed to choose one of the products. Evaluation of efficacy and safety of both products. Both products showed immediate, good results after injection and touch-up and demonstrated good durability over time. Participant preference for optional treatment at the end of the study favoured mono-HA. Both products were well tolerated, without serious adverse events. The effect after injection of mono-HA and bi-HA is generally comparable, although there was a trend in favor of mono-HA. Materials and funding for this study were provided by Teoxane, Geneva, Switzerland.