Correction Of Folds Research Articles

Evaluation of the long-term safety and biodegradability of hyaluronic acid dermal fillers (YVOIRE® ) for the correction of nasolabial folds: Two multicenter, prospective, observational cohort studies.

The therapeutic effects of hyaluronic acid dermal fillers to correct facial wrinkles and folds usually last up to 6-12months. Few studies have evaluated their long-term safety. To evaluate the long-term safety and biodegradability of two hyaluronic acid dermal fillers (YVOIRE® classics and YVOIRE® volumes) for the correction of nasolabial folds (NLFs) in two prospective, observational studies. Subjects scheduled to receive the injections of YVOIRE® classics (N=503) or YVOIRE® volumes (N=503) at NLFs were followed up until complete clinical biodegradation, defined as a change in Wrinkle Severity Rating Scale (WSRS) score of ≥0 from baseline. The primary biodegradation endpoint was the proportion of subjects with complete clinical biodegradation during or after the 104-week post-treatment period. Complete clinical biodegradation was observed in 93.5% [95% CI 91.0%-95.5%] of 494 assessable YVOIRE® classics recipients and 98.5% [95% CI 97.0%-99.4%] of 469 YVOIRE® volumes recipients during the 104-week post-treatment period. In most subjects, complete clinical biodegradation was observed within 52weeks of the last treatment. Treatment-related adverse events (AEs) (mostly mild local injection-site reactions) occurred within 52weeks post-treatment, in 68.2% and 75.0% of YVOIRE® classics and YVOIRE® volumes recipients, respectively. During the 12 to 18months after YVOIRE® volumes injection, 0.6% of subjects had treatment-related AEs (local injection-site reactions). No treatment-related AEs occurred 12 to 24months after YVOIRE® classics injection. YVOIRE® classics and YVOIRE® volumes can be safely used to correct NLFs. Total clinical biodegradation tends to occur within 12months of injection.

A randomized, participant- and evaluator-blinded, matched-pair prospective study to compare the safety and efficacy between polycaprolactone-based fillers in the correction of nasolabial folds.

Polycaprolactone (PCL)-based fillers are widely used for skin rejuvenation and wrinkle reduction. The objective of this study is to compare the efficacy and safety of newly developed PCL-based fillers (SYB filler®; SF-01) and widely used existing PCL-based fillers (Ellansé-M®) for correction of moderate-to-severe nasolabial folds. In a randomized, participant-and evaluator-blinded, matched-pair, prospective study, participants were randomized for injections of SF-01 or Ellansé-M® in both nasolabial folds. Efficacy was evaluated using the Wrinkle Severity Rating Scale (WSRS), Global Esthetic Improvement Scale (GAIS), and a three-dimensional (3D) scanner. All adverse events (AEs) were examined and reported. At month 12, both SF-01-and Ellansé-M®-treated groups showed statistically significant improvements in the WSRS, GAIS, and 3D scanner scores compared to baseline. The difference in changes in WSRS scores at month 12 between the two groups was 0.08 ± 0.34 compared to baseline. The upper limit of the 95.0% confidence interval was 0.0031, which was lower than the predefined margin for non-inferiority (0.35). All AEs were injection site-related (swelling, pain, and erythema) and disappeared within 30 min after the procedure. SF-01 was non-inferior to Ellansé-M® and demonstrated favorable efficacy and safety at 12 months after correcting moderate-to-severe nasolabial folds.

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 .

Efficacy and safety of two hyaluronic acid fillers withdifferent injection depths for the correction of moderate-to-severe nasolabial folds: A 52-week, prospective, randomized, double-blinded study in a Chinese population.

Hyaluronic acid (HA) fillers are known to be effective for the correction of facial wrinkles and folds, but there is no clinical study that compares the efficacy of small-to-medium-particle HA fillers and large-particle HA fillers for the correction of nasolabial folds (NLFs). Moreover, injection depth also plays an important role in the correction of NLFs as well as improvement of facial aesthetics. To assess the efficacy, safety, and durability of a small-to-medium-particle HA filler, Restylane, and a large-particle HA filler, Yishumei, as well as the effect of injection depth in the correction of moderate-to-severe NLFs and facial aesthetics in a Chinese population. This 52-week, prospective, randomized, double-blind study enrolled 100 participants with moderate-to-severe NLFs. The participants were randomized to receive either Restylane (Group A) or Yishumei (Group B). Group A and Group B were further randomly divided into a superficial injection group (Group A1 & B1) and a deep injection group (Group A2&B2) according to injection depth. Improvement in the Wrinkle Severity Rating Scale (WSRS) score and Global Aesthetic Improvement Scale (GAIS) and participants' satisfaction were evaluated as endpoints. All adverse events were monitored throughout the study. The treatments were well tolerated by all the participants. All four groups showed a reduction in their mean WSRS scores and GAIS scores by week 12. At week 24, the WSRS and GAIS scores did not change in Group A1 and A2, while participants in Group B1 and Group B2had higher WSRS and GAIS scores than those in the previous weeks. By week 52, the WSRS scores in all the groups returned to almost baseline levels. The mean FACE-Q scores increased compared with the baseline scores in all groups through week 24. Most participants were satisfied with their treatment, and no meaningful differences were found between the fillers in terms of participant satisfaction. The most common adverse events were swelling, redness, and tenderness at the injection site, but they resolved spontaneously without treatment. The two HA fillers had good therapeutic effect on NLFs in the early stage of treatment, but Restylane had a more prolonged effect. Moreover, compared with the superficial injection, the deep injection provided slight midface lifting and improved facial aesthetics.

Safety and Efficacy of Polymethylmethacrylate-Collagen Gel Filler for Correction of the Pre-jowl Sulcus: A 24-month Prospective Study.

BackgroundPolymethylmethacrylate (PMMA)-collagen gel is approved for the correction of nasolabial folds and severe atrophic, distensible facial acne scars on the cheek. However, fillers are often used off-label in clinical practice, necessitating additional study of safety and efficacy.ObjectivesTo determine the safety and efficacy of PMMA-collagen gel for the correction of lower face aging, specifically the pre-jowl sulcus.MethodsIn this prospective, single-center, 1-year study (N = 20) and additional 1-year extension (N = 10), 20 patients with a pretreatment score of 2, 3, or 4 on the 5-point Merz Aesthetic Scale for jawline at rest were eligible for treatment with PMMA-collagen gel. Efficacy was measured by blinded review using the jawline scale, Subject and Physician Global Aesthetic Improvement Scale (GAIS) and Subject Satisfaction scores, collected at weeks 4, 12, 26, 52, and 104.ResultsImprovement in jawline score was significant at all posttreatment time points up to 104 weeks (P < 0.01). The percentage of patients with subject-reported GAIS ratings of “improved” or “much improved” was 79% at 12 weeks and ratings were maintained at 76% at 52 weeks and increased to 90% at week 104. At 52 and 104 weeks, 82% and 100% of patients, respectively, were at least “somewhat satisfied.” All adverse events were minor.ConclusionsPMMA-collagen gel is well tolerated and effective for durable correction of the pre-jowl sulcus and jawline.Level of Evidence: 4

Monophasic versus biphasic hyaluronic acid filler for correcting nasolabial folds: a systematic review and meta-analysis.

Hyaluronic acid (HA) fillers are the most popular dermal fillers for wrinkle correction and facial rejuvenation. Recently, there has been an interest toward classifying HA fillers based on the cross-linking properties into monophasic (MHA) and biphasic (BHA) fillers. We aimed to compare the efficacy and safety outcomes between MHA and BHA fillers for the correction of nasolabial folds (NLFs). We searched Medline, Embase, and CENTRAL for randomized controlled trials (RCTs) that compared MHA filler to BHA filler for individuals with moderate-to-severe bilateral NLFs. We sought to evaluate the following outcomes: Wrinkle severity rating scale (WSRS), pain on visual analog scale (VAS), global aesthetic improvement scale (GAIS), and adverse events. The standardized mean difference (SMD) was used to represent continuous outcomes while risk ratio (RR) was used to represent dichotomous outcomes. A total of 11 RCTs that enrolled 935 participants deemed eligible. MHA filler revealed a significant improvement in the overall WSRS score and GAIS score compared to BHA filler (SMD=-0.38, 95% CI -0.49 to -0.27 and SMD=0.34, 95% CI 0.24-0.45, respectively). No significant difference was noted between MHA and BHA fillers in terms of pain score or adverse events (SMD=-0.39, 95% CI -0.81-0.03 and RR=1.00, 95% CI 0.89-1.12, respectively). MHA filler showed discernable cosmetic results and comparable effective and tolerability to BHA filler.

Using New Autologous Tissue Filler Improved Nasolabial Folds-Single-Armed Pilot Study.

To evaluate the clinical efficacy and safety of the new autologous tissue filler derived from autologous skin and hairs for correction of nasolabial folds. The new injectable soft tissue filler is prepared from autologous fibroblasts and keratin gel. A total of 40 patients were enrolled in this single-armed pilot study, all of them received the new filler injection treatment for correction nasolabial folds. Following up with the patients, collection of their clinical features, including photographs, satisfaction, and information on adverse events at the 1st, 3rd, 6th, 12th, and 24th months after injection. The clinical efficacy of each patient was evaluated by masked evaluators and independent expert panels, based on the Wrinkle Severity Rating Scale (WSRS) at different time points after the injection. Thirty-two patients completed the 24-months follow-up, obtaining at least 93.8% improvement, and 75% of them had significantly improved. Base on the self-satisfaction assessment (SSA) indicated that all of them were satisfied with the results. No adverse effects of filler injection treatment were observed during the follow-up. The combination of autologous keratin and fibroblasts as a new tissue engineering soft tissue filler has shown safety and long-term efficiency in correcting nasolabial folds, with high satisfaction and desirable result. 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 .

Commentary on: Skin Tightening With Hyperdilute CaHA: Dilution Practices and Practical Guidance for Clinical Practice.

Since 2006 calcium hydroxylapatite (CaHA; Radiesse, Merz North America, Raleigh, NC) has been approved by the FDA for correction of facial wrinkles and folds, for human immunodeficiency virus–associated facial wasting, and, since 2015, for hand augmentation. The commercial product is composed of approximately 30% CaHA and 70% carrier gel, providing a dual effect—filling/volumizing tissue and biostimulating the tissue’s own fibroblasts. Nondiluted product is characterized by high viscoelastic properties and is therefore particularly suited to lifting and revolumizing aging soft tissue in the midface. The current FDA-approved mixing protocol produces a final lidocaine concentration of 0.3%. Although not yet FDA-approved, dilute (1:1) and hyperdilute (1:2 and higher) CaHA have become widely used for skin tightening as a novel technique that takes advantage of the biostimulatory properties of CaHA.1 The first studies used hyperdilute CaHA in the neck and décolletage to improve the mechanical properties of skin and stimulate neocollagenesis. Several histologic studies have shown that CaHA stimulates neocollagenesis, neoelastogenesis, angiogenesis, and fibroblast proliferation, thereby significantly reducing skin laxity and improving contours and firmness in individuals with age-associated skin changes—effecting these changes without producing any volumizing effect.2

Cable-Stayed Face Lift: An Innovative Short-Scar Lift for Better Correction of Nasolabial Folds in East Asians.

The improvement of nasolabial folds by either lateral superficial musculoaponeurotic system rhytidectomy or minimal access cranial suspension lift alone is commonly performed, but patient satisfaction is often limited in East Asians. An innovative technique, termed the cable-stayed face lift, which combines the strengths of lateral superficial musculoaponeurotic system rhytidectomy and minimal access cranial suspension lift, was developed for improved results. Between 2016 and 2019, 20 cable-stayed face lifts were performed in a single hospital. Two plastic surgeons independently evaluated postsurgery outcomes using a five-point Likert scale, where 5 = excellent, 4 = good, 3 = fair, 2 = no change, and 1 = worse. Patient satisfaction was assessed by relevant items from the FACE-Q questionnaire. Twenty patients with a mean age of 51 years underwent face-lift surgery. The mean follow-up ± SD was 11.3 ± 9.8 months. The five-point Likert scale score evaluated by surgeons was 3.65 ± 1.08. Patient-perceived age visual analogue scale (7.8 ± 4.4) exhibited a difference between preoperative actual age and postoperative apparent age. Patients demonstrated high satisfaction with outcome (67.5 ± 16.2) and satisfaction with lower face and jawline (76.2 ± 14.9). No major complication, hematoma, or seroma was observed. The authors' approach-cable-stayed face lift-offers a good alternative to provide a more effective effacement of nasolabial folds, by lifting the nasolabial folds with parallel vector and lower face and neck with the vertical vector. Therapeutic, IV.

25987 A randomized, evaluator-blinded, multicenter study to evaluate safety and effectiveness of a biostimulatory poly-L-lactic acid injectable implant after changes in reconstitution

Objectives: To evaluate safety and effectiveness of a biostimulatory poly-L-lactic acid (PLLA) injectable implant for correction of nasolabial folds after changes in reconstitution and injection procedures compared with US label.

A Randomized Study on PLLA Using Higher Dilution Volume and Immediate Use Following Reconstitution.

The reconstitution volume of a PLLA-containing injectable device has gradually increased in clinical practice, often in combination with adding lidocaine to the solution. This study, SCRIPT (Sculptra Contemporary Reconstitution &amp; Injection Procedure Trial) evaluated PLLA for correction of nasolabial folds after changes in reconstitution and injection procedures. Primary endpoint for effectiveness was change from baseline of nasolabial folds, assessed by blinded evaluation using a validated wrinkle assessment scale (WAS), at week 48. Subjects were treated to optimal correction of nasolabial folds at a single treatment regimen consisting of &le;4 injection sessions, with PLLA reconstituted with 8 mL or 5 mL sterile water for injection (SWFI), randomized 2:1. The 8 mL product included an additional 1 mL 2%-lidocaine and was injected immediately following reconstitution. Assessments included wrinkle severity, aesthetic improvement and safety. A total of 80 subjects were included in the study. Most subjects were female (95%), mean age was 51.5 years. Primary endpoint was met and subjects from both study groups demonstrated high WAS responder rates (&ge;1-grade improvement from baseline) at week 24 (&ge;75%) and week 48 (&ge;67%). Aesthetic improvement was high (&ge;86%) throughout the study. Adverse events related to study product or injection procedure were mostly mild and transient. PLLA reconstituted with 8 mL SWFI demonstrated a comparable treatment effect to that of the reference group in reducing wrinkle severity of nasolabial folds. Safety was not compromised using a higher reconstitution volume including lidocaine, injected immediately after reconstitution. J Drugs Dermatol. 2021;20(7):&nbsp;760-766.. doi:10.36849/JDD.6034THIS ARTICLE HAD BEEN MADE AVAILABLE FREE OF CHARGE. PLEASE SCROLL DOWN TO ACCESS THE FULL TEXT OF THIS ARTICLE WITHOUT LOGGING IN. NO PURCHASE NECESSARY. PLEASE CONTACT THE PUBLISHER WITH ANY QUESTIONS.

A Randomized, Evaluator-Blind, Split-Face Study Evaluating the Safety and Efficacy of Calcium Hydroxylapatite for Jawline Augmentation.

Jawline augmentation with calcium hydroxylapatite has not yet been evaluated in a prospective study with a split-face design. This study aims to perform the first randomized controlled, split-face study on the efficacy and safety of calcium hydroxylapatite for jawline augmentation using the needle and cannula technique. To perform the first randomized controlled, split-face study on the efficacy and safety of calcium hydroxylapatite for jawline augmentation using the needle and cannula technique. This is a single-site, randomized, evaluator-blind trial enrolling a total of 10 healthy subjects with at least Grade 1 (mild) on a 4-point Jawline Scale. One side of the face was randomized to receive 1 to 2 syringes of calcium hydroxylapatite with lidocaine (total of 3 mL) for correction of wrinkles and folds along the jawline using both the cannula and needle method, and a balancing treatment will be performed 1 month later. Blinded investigator and subject evaluations will be performed immediately after treatment and at the 30-, 60-, and 90-day visits. Ten subjects were enrolled and completed the trial. There was a improvement in the degree of wrinkling and skin sagging in the 4-point Jawline Scale, with an average of a 1.3-point improvement in the scale on the day of treatment and at the Day 30 visit, which remained improved greater than baseline after 3 months as graded by blinded investigators. The Clinician Global Aesthetic Improvement Score for the treated side versus control, as assessed by blinded investigators, demonstrated a improvement with a 2.3-point improvement on the 5-point scale, and by the final visit on Day 90, most patients had a much improved appearance from baseline. This study demonstrates that calcium hydroxylapatite is effective and safe for restoration and augmentation of the jawline using the unique needle and cannula technique.

European Multicenter Prospective Study Evaluating Long-Term Safety and Efficacy of the Polycaprolactone-Based Dermal Filler in Nasolabial Fold Correction.

Age-related changes affecting facial areas can be corrected using minimally invasive dermal fillers. The use of polycaprolactone-dermal filler (PCL-filler) in aesthetics is increasing. To evaluate the long-term safety and efficacy of the PCL-filler, in a European, multicenter, prospective study. Subjects (n = 90) with moderate/severe nasolabial folds (Wrinkle Severity Rating Scale [WSRS]: 3 to 4) were treated on Day 0 with a single injection of similar volume on each side; safety and efficacy assessments were performed over an 18-month period. In 1 of the 3 study centers, safety was evaluated at 30 months. At Month 12 (M12; primary endpoint), 84% of subjects showed a ≥1-point improvement on the WSRS (M6: 92%; M18: 64%). From the investigator/subject's evaluation, from Day 7 to M12, Global Aesthetic Improvement was reported for >90% of subjects, with the effect maintained for up to 18 months in >80% of patients. Subjects/investigators reported high satisfaction and skin quality improvement. Most of the immediate injection-site reactions disappeared after 2 to 4 days. No severe or unexpected adverse events were reported. This study demonstrated the long-term safety and efficacy of the PCL-filler, with safety confirmed for up to 30 months.

Medial Epicanthoplasty Using a Lower Palpebral Margin Incision Combined With a Tiny Triangular Flap.

The incidence of epicanthus is extremely high in Asians. Although many techniques have been introduced to remove the epicanthus, there are still some complications. Herein, we introduced a method involving an incision on the lower palpebral margin combined with a tiny triangular flap for correction of epicanthal folds, which is always performed in combination with double eyelid plasty. After making an incision, the ectopic medial canthal ligament was removed. The ligament pulling the medial canthus was cut along the lower palpebral margin incision, so the medial canthus could be repositioned upward. The tiny triangular flap of the medial canthus would naturally move downward and cover the lower palpebral margin incision. The skin folds on the lower palpebral margin were trimmed and sutured. After epicanthoplasty was completed, double eyelid plasty was performed using the incision or non-incision method. A total of 547 epicanthoplasties were performed during the past 7 years. The follow-up time ranged from 1 month to 5 years. Ninety-eight percent of the patients were satisfied with the results of the epicanthoplasty. The scars in the medial canthal area were tiny, the enlargement of the medial canthus was obvious, and the double eyelid line in the medial canthal area was natural and smooth. The introduced method is simple in design and can preserve the original shape of the medial canthus while widening the palpebral fissure, which is a particularly suitable approach for epicanthoplasty in Asian 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 .

Comparison of 2.5% agarose gel vs hyaluronic acid filler, for the correction of moderate to severe nasolabial folds.

BackgroundAgarose gel filler is a natural hydrocolloid with a three‐dimensional structure similar to the extracellular matrix, with gel formed by hydrogen bonds and electrostatic interactions rather than through chemical cross‐linking or polymerization.ObjectiveTo determine efficacy and safety of 2.5% agarose gel filler for the correction of nasolabial folds.MethodsIn this split‐face study, efficacy, safety, and usability of 2.5% agarose gel were compared to those of NASHA‐L. Assessments included the nasolabial fold (NLF) Wrinkle Severity Rating Scale (WSRS), Global Aesthetic Improvement Scale (GAIS [blinded investigator]), subject satisfaction, safety (adverse events), and usability.ResultsSixty‐six subjects were treated, and 46/66 (66.7%) were available for evaluation at 3 months, when mean change in WSRS was identical for both products (−1.1 ± 0.4 for 2.5% agarose; −1.1 ± 0.4 for NASHA‐L). Scores for each product remained similar across all time points and began to return to baseline between 7 and 8 months. GAIS score followed a similar pattern, rising between months 7 and 8 (2.7 ± 0.6 for 2.5% agarose at month 7‐3.3 ± 0.5 at month 8 and 2.7 ± 0.6 for NASHA‐L at month 7‐3.3 ± 0.5 at month 8). Ultrasound confirmed the longevity of both fillers between 7 and 8 months. All adverse events were transient in nature and resolved within 15 days. Most events were mild in nature, and the number of events was similar between the two fillers.ConclusionTreatment with 2.5% agarose gel resulted in improvement that persisted for between 7 and 8 months. The treatment effect was equivalent to NASHA‐L.

The use of resected SMAS as autologous graft for the correction of nasolabial folds during rejuvenating procedures.

Background and aim:Despite several techniques are proposed, treatment of nasolabial folds is often challenging. During rejuvenation procedures, the SMAS could be redraped or partially resected during the procedure. The aim of this study is to investigate the use of obtained SMAS strip as autologous graft, because of its solid but pliable consistence and fatty composition, to correct nasolabial folds during procedures with SMAS resection.MethodsBetween 2015 and 2018, 23 patients underwent SMAS graft for nasolabial fold correction. All procedures were performed under local anesthesia and no other cosmetic treatments, including HA fillers, have been done in the past 12 months.Results:22 patients were declared eligible for the study. 20 patients were female, accounting for 90,91%. Mean age was 53 years old. Ancillary procedures were performed in 17 patients, including upper blepharoplasty (3, 13,63%), upper and lower blepharoplasty (5, 22,73%) and submental neck lift with platysma plication (15, 68,18%). Mean follow-up was 9 months. No major complications have been recorded: only 1 case of minimal hematoma in the retroauricular region have been recorded and 1 patient required laser treatment for pathological scars. At follow-up, graft is completely integrated into the mid-fat compartment. As evinced from the FACE-Q analysis, the overall satisfaction rate is extremely high. These are very convincing data regarding the effectiveness of the technique and, despite a little bit longer downtime, is not invasive and led to natural long-lasting results event during motion.Conclusions:The use of SMAS graft during face-lift as nasolabial fold filler results in a satisfactory but natural filling of the folds, reducing the need for lateral tension and therefore assuring more natural results. Since its nature, SMAS, reduced in width to properly fit into the nasolabial fold, can be considered as an optimal autologous graft for replenish loss volumes of the face with aging. (www.actabiomedica.it)

A 12-Month Study to Evaluate Safety and Efficacy of Polymethylmethacrylate-Collagen Gel for Correction of Midface Volume Loss Using a Blunt Cannula as Measured by 3-D Imaging

BACKGROUND Although polymethylmethacrylate (PMMA)-collagen gel is approved for correction of nasolabial folds, there are no reports characterizing safety and efficacy in the midface, an area where fillers are often used in clinical practice. OBJECTIVE To determine the safety and efficacy of PMMA-collagen gel for long-term volume restoration in the midface. METHODS In this prospective, single-center, 12-month study, 23 subjects with a pretreatment Midface Volume Deficit Scale (MFVDS) grade of 3, 4, or 5 were treated with PMMA-collagen gel. Efficacy was measured by the investigator and blinded reviewers using the MFVDS at 3, 6, and 12 months. Subject Global Aesthetic Improvement Scale (SGAIS) and physician GAIS (PGAIS) ratings were collected at 3, 6, and 12 months. RESULTS Improvement in the MFVDS score from baseline was significant at all post-treatment time points (p &lt; .0001). All subjects with baseline MFVDS grades of 5 (severe) or 4 (significant) had a grade of 0 (none) or 1 (minimal) at 12 months. Subject GAIS (SGAIS) and PGAIS ratings of improved or much improved were 100% at Month 3 and were maintained at 12 months (PGAIS = 100%, SGAIS = 91.3%). All adverse events were minor. CONCLUSION Polymethylmethacrylate-collagen gel is safe and effective for long-lasting correction of midface volume deficit.

Efficacy and safety of a new hyaluronic acid filler for nasolabial folds: A 52-week, multicenter, randomized, evaluator/subject-blind, split-face study.

Hyaluronic acid fillers are known to be effective for correction of nasolabial folds. Recently, a novel biphasic hyaluronic acid filler incorporating lidocaine, DIVAVIVA medium has been introduced. We compared the efficacy and safety between DIVAVIVA medium and Restylane Perlane Lidocaine for moderate to severe nasolabial folds. This was a multicenter, randomized, evaluator/subject-blind, active-controlled, split-face study. A study 1 evaluated the efficacy and safety until 24weeks. Extension study, study 2, included subjects who wanted to enroll and evaluated the efficacy and safety until 52weeks. The Wrinkle Severity Rating Scale (WSRS) score, Global Aesthetic Improvement Scale, and Visual Analogue Scale measuring pain were evaluated. All adverse events were monitored. The mean change of WSRS at week 24 was -0.61±0.54 in DIVAVIVA medium group and -0.59±0.49 in Restylane Perlane Lidocaine group. The difference between two groups was 0.08, which was lower than noninferior limit. In study 2, the mean change of WSRS score at week 52 from baseline was -0.01±0.62 in DIVAVIVA group, 0.06±0.57 in Restylane Perlane Lidocaine group. The primary and secondary efficacy outcomes were also achieved in study 1 and 2. There was no significant difference in the incidence of adverse events between the two groups. DIVAVIVA medium has comparable efficacy and safety with Restylane Perlane Lidocaine for correction of moderate to severe nasolabial folds.

A physicochemical model for rationalizing SARS-CoV-2 concentration in sewage. Case study: The city of Thessaloniki in Greece

Detection of SARS-CoV-2 in sewage has been employed by several researchers as an alternative early warning indicator of virus spreading in communities, covering both symptomatic and asymptomatic cases. A factor that can seriously mislead the quantitative measurement of viral copies in sewage is the adsorption of virus fragments onto the highly porous solids suspended in wastewater, making them inaccessible. This depends not only on the available amount of suspended solids, but also on the amount of other dissolved chemicals which may influence the capacity of adsorption. On this account, the present work develops a mathematical framework, at various degrees of spatial complexity, of a physicochemical model that rationalizes the quantitative measurements of total virus fragments in sewage as regards the adsorption of virus onto suspended solids and the effect of dissolved chemicals on it. The city of Thessaloniki in Greece is employed as a convenient case study to determine the values of model variables. The present data indicate the ratio of the specific absorption (UV254/DOC) over the dissolved oxygen (DO) as the parameter with the highest correlation with viral copies. This implies a strong effect on viral inaccessibility in sewage caused (i) by the presence of humic-like substances and (ii) by virus decay due to oxidation and metabolic activity of bacteria. The present results suggest days where many fold corrections in the measurement of viral copies should be applied. As a result, although the detected RNA load in June 2020 is similar to that in April 2020, virus shedding in the city is about 5 times lower in June than in April, in line with the very low SARS-CoV-2 incidence and hospital admissions for COVID-19 in Thessaloniki in June.

A prospective, open label, multicenter, postmarket study evaluating Princess VOLUME Lidocaine for the correction of nasolabial folds.

The aim of this study was to investigate the safety and performance of Princess VOLUME Lidocaine in nasolabial fold correction. In this prospective, open label, multicenter, postmarket study subjects received injections of Princess VOLUME Lidocaine into both NLF at Baseline (Day 0) and if considered necessary by the investigator, at Week 2 (touch-up treatment). This study was conducted in Austria at the Department of Dermatology and Venereology, Medical University of Graz, at the medical aesthetic center MÄZ WIEN, and at the medical aesthetic center Ordination Dr. Bartsch, Vienna. The 62 mainly female (95.2%) subjects had a median age of 52 years with two fully visible, approximately symmetrical NLFs, each scoring grade 2 or 3 on the nasolabial fold severity rating scale (NLF-SRS) developed by Croma-Pharma. The nasolabial fold severity was assessed by NLF-SRS and Global Aesthetic Improvement Scale (GAIS) 4, 24, and 36 weeks later. Adverse events (AEs) were recorded throughout the investigation. With 95.1% of subjects showing an improvement of at least 1 grade of the NLF-SRS at 24 weeks after the treatment, the primary endpoint was achieved, and clinical performance was demonstrated. Princess VOLUME Lidocaine was well tolerated, with only mild AEs, mainly injection site reactions, reported. Subject satisfaction (≥93.5%) and GAIS scores (≥93.5% improvement) were high. Princess VOLUME Lidocaine was effective in reducing NLFs as shown by an improvement in the severity of NLFs by at least one grade in 95.1% of subjects at Weeks 4 and 24.