Global Aesthetic Improvement Scale Research Articles

A clinical study on the efficacy of high frequency therapy on nasolabial and periorbital wrinkles

ABSTRACT The high-frequency generator is considered a collagen stimulator and skin revitalizer, however there are few studies exploring its effects in the field of rejuvenation and aesthetics. Thus, this study aimed to investigate the impact of high frequency generator therapy on facial aging. A total of 26 participants aged between 50 and 60 years were selected and received high frequency generator treatment for eight weeks. The evaluation was conducted using a combination of photographic records and assessment tools, including Rosenberg scale, perception and satisfaction with treatment evaluation, overall aesthetic improvement scale, and modified Fitzpatrick scale. The analysis conducted by the Global Aesthetic Improvement Scale yielded significant results. The Modified Fitzpatrick Wrinkle Scale showed that high frequency therapy led to statistically significant improvements in the appearance of nasolabial wrinkles (right T0: 1.48, T8: 0.87; left T0: 1.51, T8: 1.05) and periorbital wrinkles (right T0: 1.69, T8: 1.05; left T0: 1.71, T8: 1.08). In conclusion, high frequency generator therapy can be a highly effective tool for treating skin aging on the face, however, we recommend that future research includes control groups, and adopts objective measures to expand knowledge about the effects of high frequency.

Effectiveness and Safety of a Hyaluronic Acid Filler for Chin Augmentation and Correction of Chin Retrusion: A Multi-center, Prospective, Randomized Controlled Trial.

The chin significantly influences facial aesthetics, contributing to the overall balance and harmony of the face. This study aimed to assess the effectiveness of the hyaluronic acid filler Hyamax® Volumizer for chin augmentation and correction of chin retrusion compared to a no-treatment control. Participants aged 18-55 years with mild to moderate chin retrusion were randomized in a 3:1 ratio to receive either the treatment group (n = 150) or control group (n = 50). Evaluations included blinded assessments using the validated Galderma Chin Retrusion Scale, Global Aesthetic Improvement Scale for aesthetic enhancement, and safety follow-up. The Galderma Chin Retrusion Scale responder rate (≥1 grade improvement) was significantly higher for the treatment group (70%) compared to the control group (0%) at 6 months (p < 0.0001), and remained higher at 12 months (54.67% vs. 0%; p < 0.0001). Aesthetic improvement rates were consistently high as reported by both blinded evaluating investigator (≥89.33%) and subjects (≥91.33%). Treatment-related adverse events were mild to moderate. Hyamax® Volumizer treatment is safe and effective when injected in the chin to treat chin retrusion, with results lasting through 1 year. 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 .

Cell-Free Fat Extract with Anti-melanogenic Property Improves the Appearance of Infraorbital Dark Circles: A Preliminary Clinical Study.

The formation of infraorbital dark circles involves various factors including hyperpigmentation, skin aging and laxity. This study is to investigate whether cell-free fat extract (CEFFE) inhibits melanin synthesis and improves the appearance of infraorbital dark circles. Imaging systems analysed the melanin content in three groups of zebrafish embryos treated with 0 (CTRL), 100, and 200μg/mL of CEFFE. Eleven patients with infraorbital dark circles were enrolled and received intradermal injections of autologous CEFFE. Clinical trial assessments included subjective assessments (Global Aesthetic Improvement Scale and Likert satisfaction scale) and objective assessments (standard two-dimensional photographs, VISIA® photographs, and infraorbital skin colour measurement). In the experiment of zebrafish embryos, the melanin content of CEFFE treatment was significantly reduced. In clinical trial, 72.73% of patients considered CEFFE treatment for infraorbital dark circles to be effective, and more than half of the patients were satisfied with the treatment. In the evaluation of skin colour at the inner, middle, and outer edges of the infraorbital dark circles, there was a gradual improvement in infraorbital skin colour after each treatment and at the 3-month follow-up, with a statistically significant improvement in skin colour on the outer edge of the infraorbital dark circles (p < 0.05). Simultaneously, we observed a reduction in periocular wrinkles, with a significant difference at the 3-month follow-up (p < 0.05). The events observed included bruising, erythema, and oedema, which resolved spontaneously. Our study demonstrated that CEFFE inhibits melanogenesis and is a safe and effective treatment for infraorbital dark circles. 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 .

Double-Layer Cogged Thread Lifting Technique: A Superficial- and Deep-Layer Lifting Method.

Although thread lifting is a widely performed method, the degree of initial lifting and sustainability varies based on how the threads are inserted into the skin layers. This study aimed to perform thread lifting on 43 patients to achieve maximum lifting effects using thicker threads in the deeper layers of the subcutaneous fat layer and thinner threads in the shallower layers. Immediately after the procedure, we measured the depth of the inserted threads using ultrasonography and evaluated the results based on patient satisfaction and the global aesthetic improvement scale (GAIS). At the end of the procedure, an upright position was employed to check for dimples or irregularities, and intraoral observation was also conducted. Patient satisfaction significantly increased immediately after the procedure compared to that before the procedure. High GAIS scores were maintained even after 6months, indicating high satisfaction with the procedure. Inserting threads into multiple layers was deemed more effective than inserting them into a single layer. Thread lifting on 43 patients was used to maximize lifting effects by utilizing thicker threads in deeper subcutaneous fat layers and thinner threads in shallower ones. Our procedure maintained high global aesthetic improvement scale (GAIS) scores even after 6months, indicating patient satisfaction. Multiple layers were shown to be more effective than a single layer for thread insertion. 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 .

Microfocused Ultrasound With Visualization (MFU-V) and Hyperdilute Calcium Hydroxylapatite (CaHA-CMC) of the Lower Face and Submentum to Treat Skin Laxity: A Pilot Study Demonstrating Superiority of MFU-V First Followed by Hyperdilute CaHA-CMC.

Microfocused ultrasound with visualization (MFU-V) and hyperdilute calcium hydroxylapatite-carboxymethylcellulose (CaHA-CMC) dermal injections are effective for improving skin laxity in the lower face and submentum by stimulating neocollagenesis and neoelastogenesis. Combining these treatments in an optimal order may inform best practices in aesthetic dermatology. Despite their frequent concurrent use, no study has evaluated the impact of treatment order. This study aimed to determine the optimal sequence for administering MFU-V and hyperdilute CaHA-CMC. Twelve healthy women aged 35-65 were randomized into two groups. Group A received MFU-V followed by hyperdilute CaHA-CMC six weeks later, while Group B received the treatments in the opposite order. Evaluations included histological assessments, aesthetic outcomes, and safety measures. Group A showed greater improvements in subjective global aesthetic improvement scale (sGAIS), investigator global aesthetic improvement scale (iGAIS), and FACE-Q patient-perceived age visual analog scale (VAS) scores. Both groups exhibited similar improvements in FACE-Q Satisfaction with Lower Face and Jawline scores. Histologically, both groups demonstrated significant elastin production at the 120-day follow-up. Group A showed a 143% relative increase in elastin coverage, compared to a 63% increase in Group B. Consequently, Group A exhibited superior qualitative and histologic improvements. Administering MFU-V first, followed by hyperdilute CaHA-CMC six weeks later, is the optimal sequence for this combination therapy. Although both groups experienced increased elastin synthesis and aesthetic improvements, the order of treatments significantly impacted the outcomes, favoring the sequence used in Group A. This finding provides valuable insight for optimizing combination therapies in aesthetic dermatology.

Clinical Outcomes and Safety Profile of a Dextranomer-Hyaluronic Acid Hybrid Filler: A Case Series Analysis.

The demand for aesthetic treatments targeting the middle and lower face is on the rise, especially because of changes in appearance associated with aging. This study aimed to assess the use of a hybrid filler for sculpting and contouring of the chin, jaw, and malar region. A retrospective analysis was performed on patients who underwent jaw and chin contouring and cheek augmentation using a hybrid filler (hyaluronic acid and dextranomer). The evaluation focused on the naturalness of appearance, enhancement in volume, and the durability of the results, employing a 5-point scale. Both patient satisfaction and physician evaluations were measured using the Likert scale and the Global Aesthetic Improvement Scale (GAIS), respectively. Follow-up with patients extended up to 6 months after treatment, during which any treatment-related adverse events (AEs) were meticulously recorded and analyzed. Nineteen patients participated in the study, receiving an average injection volume of 2.4 ± 0.9 mL to attain the desired outcomes. The evaluation of natural appearance, volumizing effects, and durability at the analyzed time point consistently scored above 4. All 19 patients' aesthetic improvement was evaluated as "very much improved" and "much improved", at the GAIS score. All patients report improvement in their appearance, with 89.5% rating it as "very much improved" or "much improved" on the Likert scale. Only expected AEs such as mild pain and lower swelling were registered. The hybrid filler proved effective and safe for facial contouring, with significant patient satisfaction and minimal adverse effects.

SPLASH: Split-Body Randomized Clinical Trial of Poly-l-Lactic Acid for Adipogenesis and Volumization of the Hip Dell.

Injectable poly-l-lactic acid (PLLA-SCA) increases extracellular matrix to improve skin quality. The hip dell is an underappreciated element of gluteal aesthetics. Adipose tissue has roles in aesthetics and skin functioning. To investigate the efficacy of PLLA-SCA treatment to induce adipogenesis and volumize the hip dell. This was a double-blinded, split-body trial of 15 women with hip dell volume deficits. Each subject was randomized to have 1 hip dell treated with 150 mg of PLLA-SCA while the contralateral hip dell received the equivalent volume of saline. Subjects received 3 treatments at 1-month intervals and were followed for 9 months. Assessments included physician global aesthetic improvement scale, ultrasonography, and histologic examination. Blinded investigators rated PLLA-SCA-treated hip dells as improved and much improved. The dermis and adipose layers increased in thickness by 26.1% and 27%. These measures, in addition to collagen and elastic fiber quality, were significantly improved compared with saline-treated hip dells, which did not change from baseline. Subject satisfaction was also significantly greater on the PLLA-SCA-treated side. No subject experienced significant adverse effects. Poly-l-lactic acid is a safe and effective method for durable volumization and aesthetic improvement of the hip dell. PLLA-SCA may promote adipogenesis and elastogenesis.

Safety and efficacy of the amino acid crosslinked hyaluronic acid in the treatment of temple hollowing.

Loss of volume in the temples is an early sign of aging and often gives the impression of a gaunt and emaciated appearance. The authors conduct a clinical study to investigate the safety and effectiveness of the amino acid crosslinked hyaluronic acid (ACHA) for the treatment of temple hollowing. 75 subjects with Temple Hollowing Scale (THS) from 2 to 4 were enrolled and assigned according to the ratio of 2 (ACHA group, n=50): 1 (no treatment control group, n=25). All subjects were assessed at the 12-month follow-up visit using the THS, Global Aesthetic Improvement Scale (GAIS), ultrasound, and three-dimensional scanning. Subjects were instructed to report any adverse events (AEs) within 14 days after the ACHA treatment. An average volume of 4.72±1.13ml was injected into the temples. We received 18 treatment-related AEs reported by 10 subjects. Compared with the control group, THS, GAIS, and soft tissue thickness were significantly improved in the ACHA group at 1 month, 6, and 12 months after injection. Three-dimensional scanning showed that ACHA could maintain a certain volume in the temple 12 months after ACHA injection. ACHA is an effective and safe hyaluronic acid for patients with minimal to severe temple hollowing.

Non-invasive system delivering microwaves energy for localized adiposity reduction, skin laxity, and cellulite: Clinical evidence

Localized adiposities are the accumulation of subcutaneous adipose tissue resulting in an alteration of the body silhouette. This study evaluates the efficacy and safety of a non-invasive microwaves (MWs) device for the treatment of localized adiposities of the thighs and abdomen. Sixteen women enrolled underwent four sessions with the study device at intervals of 30 days. Clinical evaluation, anthropometric evaluation, ultrasound evaluations, and 3D photographs were performed. Cellulite and skin laxity were evaluated. Patients filled 4-points Global Aesthetic Improvement Scale (GAIS) and 10-points Visual Analog Scale. The mean abdominal circumference significantly (P &lt;0.05) decreased 4 weeks after the last treatment, and the mean culotte/thighs circumference significantly (P &lt; 0.05) decreased 4 weeks after the last treatment. Both cellulite and skin laxity were improved. The GAIS scores showed satisfactory results. No adverse effects were observed. This MWs system has been found to be safe and effective in the reduction of body circumferences.

Microneedling With RF-Assisted Skin Penetration Improves the Hard-to-Treat Periorbital Wrinkles: Nonrandomized Clinical Trial.

This prospective study evaluates the efficacy and safety of minimally invasive radiofrequency microneedling (RFMN) for the correction of periorbital wrinkles. This study aimed to address the challenges posed by the periorbital region's unique anatomy and the limitations of existing non-surgical treatments. Twenty-four subjects, ranging from 34 to 54 years old with Fitzpatrick skin types II-V, underwent a series of treatments using the Voluderm RF microneedling device. Participants were divided into two groups based on the severity of their wrinkles and treated with customized protocols over four sessions, with a 3-month follow-up to assess outcomes. Efficacy was determined through comparisons of pre-treatment and post-treatment wrinkle severity, using the Lemperle Classification of Facial Wrinkles (LFW) and the Global Aesthetic Improvement Scale, evaluated by both the investigators and the patients. Safety and tolerability were assessed through adverse event reporting and a Visual Analog Scale for treatment discomfort. The results demonstrated a statistically significant reduction in periorbital wrinkle severity, with an average 49% decrease of LFW score and improvements noted across all skin types in both groups. The aggregated facial LFW score decreased from baseline mean 13.00 ± 4.75 to 6.09 ± 3.90 (p < 0.05). The treatment was well tolerated without anesthetics, with minimal downtime and few adverse events, which were transient and resolved without intervention. The efficacy of Voluderm RF microneedling in improving periorbital wrinkles of variable severity was demonstrated in patients with diverse skin types. The unique RF-assisted mechanism of the skin penetration granted a high tolerability of the treatments, negligible downtime, and minimum number of adverse events with self-resolution.

Micro-Coring: A Novel Approach to Perioral Rejuvenation.

A long philtrum and poor perioral skin quality are stigmata of the aging face. Micro-Coring is a novel technology that allows for scarless skin removal. In this study we aimed to determine whether micro-coring can shorten the philtrum and improve perioral skin quality. A retrospective cohort study was performed on patients who underwent facelift with perioral micro-coring and age- and BMI-matched controls who underwent facelift alone. Preoperative and postoperative 3-dimensional facial imaging was performed. Standard perioral distances and percentage of change were calculated. Perioral skin quality was evaluated by blinded raters with the Scientific Assessment Scale of Skin Quality (SASSQ) and Global Aesthetic Improvement Scale (GAIS). Thirteen patients and 13 controls were included, with a mean follow-up of 8.9 months (range 3.0-21.5). Patients had significantly shorter mean philtrum length postoperatively compared to preoperatively, with an average decrease of 6.18% (±2.25%; P < .05). Controls did not experience significant changes in philtrum length (P > .05). There were no significant changes in other perioral measurements. Perioral skin elasticity and wrinkles significantly improved in patients compared to controls and patients had significantly greater GAIS scores (P < .05). Micro-Coring can achieve perioral rejuvenation through measurable shortening of the philtrum and observable improvement in skin quality. Nonsurgical techniques continue to find new ways to achieve aesthetic goals without significant recovery or scarring and offer value to patients and clinicians.

Effectiveness and Safety of IPN-20-SENSE LIDOCAINE for Lip Volume Augmentation and/or Redefinition (SMILE Study): A Non-inferiority Randomized Double-Blinded Controlled Study.

Hyaluronic acid (HA) is a widely used dermal filler for lip augmentation. IPN-20-SENSE LIDOCAINE (Laboratoires VIVACY) is a monophasic gel consisting of cross-linked HA and includes lidocaine hydrochloride for the reduction of injection-associated pain. The SMILE study was designed to assess the non-inferiority of IPN-20-SENSE LIDOCAINE compared to HA-RK-Lido in improving aesthetic lip appearance. The secondary objectives were to evaluate the effectiveness and safety of IPN-20-SENSE LIDOCAINE against the chosen similar active control device. This was a prospective, multicenter, double-blinded, randomized active controlled parallel group study undertaken in two investigational sites between May 2021 and July 2022 (14 months). The primary endpoint of this study was the proportion of subjects reporting an improvement on the Global Aesthetic Improvement Scale (GAIS) 3 months after treatment initiation. Regarding the primary endpoint, the difference between the treatment arms in the proportion of improved subjects was +7.0[-2.2;17.7]. The lower limit of this 90%CI, being above the non-inferiority margin of -15 and below zero, demonstrated the non-inferiority of IPN-20-SENSE LIDOCAINE vs. HA-RK-Lido. The secondary outcomes reported by subjects and the blinded live evaluators supported this result. All injection site reactions and device-related adverse events reported in this study were expected, already described and were mostly mild and transient. The study demonstrated the non-inferiority of IPN-20-SENSE LIDOCAINE to HA-RK-Lido in the aesthetic improvement of the lips. The effect of both treatments decreased over time. Nonetheless, aesthetic improvement was sustained longer in the IPN-20-SENSE LIDOCAINE arm. 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 .

Eyebrow reconstruction by simple elliptical excision with beveled incision – A case series of twelve patients

Patients seeking reconstructive facial surgery desire aesthetically pleasing outcomes with minimal visible scarring. For scalp incisions, bevelled angle of 45° is typicallypreferred to preserve hair follicles. However, no consensus exists regarding the ideal incision angle for the brow area. This observational study analyzed the surgical outcomes of 12 patients with eyebrow defects treated using a simple elliptical excision with a bevelled incision, addressing various indications such as posttraumatic scars, post-burn scars, and tumors. Outcomes were evaluated using the Physician Global Esthetic Improvement Scale at 7 days and 3 months post-surgery. At 7 days, 50% of patients showed very good improvement, and the other 50%showed moderate improvement. By 3 months, 33% of patients exhibited exceptional improvement, 50% showed very good improvement, and 17% demonstrated moderate improvement. This study concludes that direct excision and approximation with an angled incision along the hair follicle direction provide favorable aesthetic results for eyebrow reconstruction.

Therapeutic Performance of Needle Injection Versus Needle-Free Jet Injector System for Polynucleotide Filler in Skin Rejuvenation.

Polynucleotide (PN) filler often causes pain and can lead to delivery inaccuracies when applied via intradermal injection using a traditional needle. To evaluate the efficacy of treatment and the pain during the procedure using conventional needle injection versus a needle-free jet system for intradermal PN filler application. In this split-face clinical trial, 10 Korean subjects were enrolled. Each subject received an intradermal injection of PN filler on one side of the face and a needle-free jet injection using CureJet on the other side. Assessments included global and 3D skin imaging at each visit. Pain intensity was evaluated using visual analogue scale (VAS) scores during the injection. Additionally, patient satisfaction and adverse events were documented. Findings revealed that Global Aesthetic Improvement Scale scores and patient satisfaction were significantly higher with the CureJet compared to the needle injection method. VAS scores were notably lower on the CureJet side. Improvements in both pore and wrinkle indices were observed from baseline, with a more pronounced improvement rate on the CureJet side compared to the needle injection side. Needle-free injection of PN for aging skin was found to be effective in enhancing pore and wrinkle improvement, while reducing associated discomfort.

HArmonyCa™ hybrid filler to restore connective tissue: An Italian real-life retrospective study.

Facial aging and dermal conditions may negatively influence the quality of life, leading patients to seek aesthetic procedures to restore a more satisfying appearance. HArmonyCa™ is a recently developed hybrid filler that combines the actions of the most common dermal fillers, hyaluronic acid (HA) and calcium hydroxylapatite (CaHA). This study investigates the efficacy and safety of HArmonyCa™ in patients affected by chrono- and photoaging and several facial skin conditions. One hundred and twenty-nine patients, affected by chrono- and photoaging, and skin conditions such as oily and acne-prone skin, rosacea, or scarring, were treated with HArmonyCa™. Injections followed the retrograde linear fanning technique. A physicians' consensus identified five optimal entry points. The physician and patients assessed treatment outcomes using the Global Aesthetic Improvement Scale (GAIS) 9 months after treatment (including immediate lift effect, skin firmness, and elasticity), and 3D images were taken for documentation. Adverse events (AEs) were evaluated immediately after the procedure and after 9 months. According to the physician's assessments, all patients displayed an improvement in facial appearance, particularly during movement, with the patients' evaluation showing agreement. Only minor AEs were reporte, which resolved spontaneously. Moreover, HArmonyCa™ treatment proved compatible with different medications and aesthetic procedures. This study shows that one treatment with HArmonyCa™ yields highly satisfactory outcomes in patients affected by skin conditions. For the first time, we show that HArmonyCa™ is a dynamic filler that improves facial laxity during movement. The treatment proved to be safe and fully compatible with other cosmetic procedures and medications.

Safety and Effectiveness of Synchronized Monopolar Radiofrequency and HIFES in Patients Injected With Botulinum Toxin.

Botulinum toxin (BT) has become one of the most frequently sought aesthetic procedures for wrinkle reduction. This study investigated the effectiveness and safety of a novel device using radiofrequency (RF) and high-intensity facial muscle stimulation (HIFES) in patients injected with BT. Twelve patients were divided into an Active (N=10) and a Control group (N=2), where the Active received four treatments and the Control none. The facial expressions documented by digital photographs (neutral) and videos (frown, smile, surprise expressions) were taken at all visits (baseline, after last Tx, 1 and 3-month follow-ups) and were evaluated using the Global Aesthetic Improvement Scale (GAIS) and 3D automated analysis. The subject's therapy comfort and satisfaction were assessed. The Active group reported high satisfaction with treatment comfort (6.3&plusmn;0.2 points on the 7-point Likert scale). 3D analysis showed reduced wrinkle severity (37.4%) and volume increase (+1.5 mL) on the cheeks at 3 months. GAIS evaluation demonstrated the most prominent improvement in smiling facial expression by 2.2&plusmn;0.1 points. No adverse events were observed. The study results suggest that the combination of HIFES and synchronized RF is a safe and effective treatment for improving facial appearance and muscle tone in patients injected with BT. J Drugs Dermatol. 2024;23(11):937-942.&nbsp; doi:10.36849/JDD.7938.

Pilot Study: Use of Stem Cell Therapy and Diced Cartilage in Secondary Rhinoplasty Cases Clinical Outcomes: The Golden Turkish Delight.

Although many techniques in the secondary rhinoplasty field have been developed in recent years, there are debates regarding achieving results with a high satisfaction rate. We aimed to share the surgical use technique in secondary rhinoplasty patients by enriching the Turkish delight technique with mesenchymal stem cells, which we described as the golden Turkish delight (GTD) technique, and the long-term patient satisfaction results. The study was planned as prospective research, and 30 secondary rhinoplasty patients who presented to our service for rhinoplasty were included. The GTD technique was applied to these patients. The patient's satisfaction with the surgical procedure was evaluated at least 9-12 months after the surgery, and the Global Aesthetic Improvement Scale (GAIS) was used as a measurement tool. Of the participants, the satisfaction levels of 30 patients were evaluated with a 1-year follow-up on average, and the rate of those who improved was found to be 80% using the GAIS score. The rate of those with high GAIS scores and those with high satisfaction levels was approximately 56%. Twenty percent of the patients were not satisfied with the result. When we evaluate the postoperative 1-year results of our patients in terms of satisfaction and complications, we may state that the absorption that may occur in the Turkish delight technique over time could give better results with the GTD technique. In addition to GTD and fat graft support, regenerative medicine products such as stromal vascular fraction are very effective in obtaining favorable results.

Pilot Study: Single-depth Superficial Ultrasound with Subdermal Injections of Diluted Calcium Hydroxylapatite for Improving Lower Face Skin Quality.

The lower face can be challenging to treat. We assessed the effectiveness of combining single-depth superficial microfocused ultrasound with visualization (MFU-V, Ultherapy; Merz North America, Inc. Raleigh, N.C.) and subdermal injections of diluted calcium hydroxylapatite (CaHA, Radiesse; Merz North America, Inc. Raleigh, N.C.) in a single session for improving skin quality in the lower face. This study enrolled women with moderate-to-severe fine lines and skin unevenness on the lower face who desired nonsurgical intervention. Single-depth MFU-V treatment (10 MHz/1.5 mm) was followed by subdermal injections of diluted (1:1) CaHA. Subjects were followed up for 24 weeks posttreatment. Objective skin quality assessments (Rv: wrinkle depth; R3z: skin unevenness) were performed using LifeViz Micro (QuantifiCare, Sophia Antipolis, France). Subjective assessments included the modified Fitzpatrick Wrinkle Scale visual analog scale, Global Aesthetic Improvement Scale, and global satisfaction scale. Twelve subjects completed the study. The mean Rv value, mean R3z value, and mean modified Fitzpatrick Wrinkle Scale visual analog scale score improved significantly from baseline to week 24 (mean differences: -0.0321 mm, -0.0684 mm, -1.1667; all P < 0.001). All subjects were rated by the investigators as having demonstrated improvement in their overall aesthetic appearance as early as week 4. All subjects were "very satisfied" or "satisfied" with their treatment from week 12 onwards. No unexpected adverse events were reported. Combination treatment with single-depth superficial MFU-V and diluted CaHA in a single session significantly improved lower facial skin quality, as assessed by both objective and subjective outcome measures.

Long-term duration and safety of Radiesse (+) for the treatment of jawline.

Calcium hydroxyapatite (CaHA)-carboxymethylcellulose (CMC)+ has unique properties that make it optimal for lifting, contouring, and defining the jawline. This long-term follow-up of a randomized, multicenter, rater-blinded trial reports efficacy and safety of CaHA-CMC(+) through 48 and up to 60 weeks post-treatment. Eligible patients were randomized (2:1) to the treatment or the control/delayed treatment group to receive CaHA-CMC(+) injections in both jawlines. While touch-ups were permitted 4 weeks post-treatment for both groups, only the treatment group was eligible for optional retreatment after 48 weeks. The primary outcome was ≥1-point improvement on both jawlines on the Merz Jawline Assessment Scale (MJAS); secondary endpoints included the Subject Global Aesthetic Improvement Scale (SGAIS) among others. Post hoc analysis included pooling up to 48-week data from the combined treatment and control/delayed groups and 60-week data for the treatment group. Overall, 175 received treatment. MJAS responder rates were 77.9%, 78.7%, and 62.9% at 12, 24, and 48 weeks post-treatment, respectively. Responder rate on the MJAS at 60 weeks was 74.6% for those who received retreatment and 43.5% for those patients who received only the initial and touchup treatments. SGAIS scores demonstrated 93.4%, 85.6%, and 68.5% of patients rated themselves very much improved after 12, 24, and 48 weeks, respectively. Adverse events consisted of procedure or CaHA-CMC(+)-related events that were mostly resolved and overwhelmingly mild. CaHA-CMC(+) produced clinically meaningful and long-lasting improvements in jawline contour and was well tolerated in patients through 60 weeks. ClinicalTrials.gov Identifier: NCT03583359.

A Multicenter, Randomized, Double-Blind, Parallel-Grouped, Positive-Controlled, Non-Inferiority Clinical Study to Evaluate the Efficacy and Safety of Injectable Calcium Hydroxylapatite Microsphere Hydrogel Fillers in the Correction of Nasolabial Fold in Chinese Subjects.

Soft tissue fillers are used to improve the appearance of nasolabial folds (NLFs). This study aimed to compare the efficacy and safety of a new calcium hydroxylapatite microsphere hydrogel filler (Aphranel) versus Restylane for correcting NLFs. In this multicenter, randomized, double-blind, parallel-grouped, positive-controlled, non-inferiority trial, 210 subjects were randomized to bilateral NLF treatment with Aphranel and Restylane on either side of the NLF. NLF was assessed before and right after injection and at the first week, first month, third, sixth, and 12 months. The primary efficacy endpoint was the WSRS improvement rate for the NLF, defined as ≥ 1 point improvement at Week 24. The secondary efficacy endpoints include the WSRS score assessed by investigators and the independent review committee (IRC) and the Global Aesthetic Improvement Scale (GAIS) evaluated by the subjects, investigators, and IRC over time. Randomization was performed using a computer-generated randomization list. To ensure the double-blind nature of the study, neither the physicians administering the injections nor the patients receiving them were aware of the specific product being used. All syringes were identical in appearance, with labels coded instead of indicating the product name. The preparation of the injection products was handled by nurses who were not involved in the treatment process, thereby maintaining the blinding of both the physicians and the patients to the treatment assignment. A total of 188 subjects (168 women and 20 men) completed the 12-month follow-up. The investigator-evaluated improvement rates using WSRS at 24 weeks were 84.04% for Aphranel and 78.72% for Restylane. The IRC-evaluated improvement rates using WSRS at 24 weeks were 72.34% for Aphranel and 70.21% for Restylane. Aphranel was shown to be statistically non-inferior to Restylane (P>0.05). Both the investigator and IRC-assessed WSRS scores over time showed that the mean scores for Aphranel were non-inferior to the mean scores for Restylane (all P>0.05). There was no difference between the Aphranel and Restylane groups according to the subjects, investigators, and IRC-assessed GAIS score at any time point (all P>0.05). Both devices' most frequently reported adverse events were injection site swelling and procedural pain. This study confirms that Aphranel is an effective and safe treatment for correcting NLFs in Chinese subjects. 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 .