Dermal Fillers Research Articles

Facial Filler Injections– Questions Patients Ask and Where They Find Answers

Introduction: The most pressing questions patients ask about facial fillers and the sources to which patients are directed remain incompletely understood. Methods: The search engine optimization tool Ahrefs was utilized to extract Google metadata on searches performed in the United States. The most frequently asked questions were categorized by topic, while websites were categorized by authoring organization. JAMA benchmark criteria were used for website information quality assessment. Results: A total of 300 questions for the term “fillers” were extracted. The majority of search queries (24.0%) and monthly search volume (39.3%) pertained to procedural costs. The mean JAMA score for private practice sources (1.1 ± 0.57) was significantly lower than that of corporate sources (2.6 ± 0.55, p= 0.0003) but not significantly lower than academic pages (1.6 ± 1.34, p=0.483). With respect to monthly search volume, queries concerning lip fillers have been increasingly asked at a rate that exceeds other injection sites. Conclusion: Online searches for facial fillers often involve the topic of cost, and frequently direct patients to websites that contain inadequate information on authorship, attribution, disclosure and currency. When compared to other anatomic sites, search queries involving lip fillers have increased over the last three years.

Patient Safety: Acknowledging Acute Angioedema Following Cosmetic Injections

To report a case of acute angioedema following hyaluronic acid filler and onabotulinumtoxinA injection in an individual with allergies, recent viral vaccination, and polymyalgia rheumatica. This is a retrospective case report. A 63-year-old female with a history of allergies, asthma, and polymyalgia rheumatica on lisinopril presented with angioedema 4 hours following facial filler injection and botulinum toxin injection. The patient was successfully treated with epinephrine, diphenhydramine, and methylprednisolone. Although cosmetic injections are commonly performed, clinicians must be vigilant about rare, yet serious side-effects such as angioedema. This case underscores the importance of thoroughly evaluating medical histories before cosmetic injections and addressing patient concerns after the procedure.

Clavicular Contouring with a Novel Subperiosteal Filler Injection Technique: A Single-Case Study.

Injectable cosmetic procedures are increasingly popular among beauty seekers as rapid technology and material advancements making it easier to achieve desired results through minimal trauma. The technique of subperiosteal injection, which is not yet introduced to the field of medical esthetics, may achieve more satisfying results. This study confirms the possibility of subperiosteal injection of dermal filler, using the clavicle area as the validation region, and has been validated by ultrasound examinations. This novel injection technique combining sharp and cannula successfully achieves subperiosteal filling injections, aiming to shape clear contours by utilizing subperiosteal filling and addressing the displacement issues of conventionally injected dermal filler, thereby achieving long-term reliable results. The new technique involves linear limited subperiosteal dissection using a cannula, followed by further expansion of the periosteum through injection pressure to complete the injection of dermal filler and retain it beneath the periosteum. The conclusion drawn from clinical observation and ultrasound validation confirms that the dermal filler is indeed injected at the subperiosteal level and provides very stable support. The results at the 6-month follow-up remain ideal. This subperiosteal injection technique is easy to practice and conductive to promotion. In terms of results, it achieves long-term stable outcomes that traditional injection methods cannot achieve. Although the clavicle area was used as the validation region, this technique can also be applied to many conventional facial injection sites. 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 https://www.springer.com/00266 .

Best Practices for the Use of High-Frequency Ultrasound to Guide Aesthetic Filler Injections—Part 2: Middle Third of the Face, Nose, and Tear Troughs

The midface is a key area in facial aesthetics, highly susceptible to age-related changes such as fat pad absorption, bone resorption, and loss of skin elasticity. These changes lead to the formation of prominent folds, such as the nasolabial fold. In addition, critical vascular structures and non-vascular components, such as the facial artery, angular artery, and parotid gland, make this region prone to complications during filler injections. High-frequency ultrasound (HFUS) offers real-time, radiation-free visualization of facial anatomy, enabling injectors to accurately target the desired treatment planes and avoid critical structures. This article is the second in a series of articles on ultrasound-guided facial injections and focuses on the midface. It provides a detailed overview of the sonographic anatomy of key areas, including the nose, tear trough, nasolabial fold, zygomatic, and preauricular regions. Step-by-step techniques for ultrasound-guided filler injections are described, emphasizing the importance of scanning both before and during injections to ensure safe filler placement. By using ultrasound in this area, injectors can possibly minimize risks such as vascular occlusion and other complications, such as the Tyndall effect and intra-parotid injection. With ongoing advancements, ultrasound-guided injections are expected to become more refined, enhancing both aesthetic outcomes and patient safety.

Hyamax® Monophasic Volumizer Dermal Fillers for Chin Restoration: A Prospective, Single-Center, Investigator-Blinded, Randomized Controlled Trial

Hyamax® Monophasic Volumizer Dermal Fillers for Chin Restoration: A Prospective, Single-Center, Investigator-Blinded, Randomized Controlled Trial

Vascular Labeling of Extracranial Head and Neck Vessels Using Silicone Dye Injection: An Effective Method for Cadaver-Based Facial Surgery Training

Abstract Background Silicone dye injection is a well-described technique for studying vascular anatomy. Plastic surgeons routinely participate in cadaveric workshops and are involved in the preparation of vascular-labeled cadavers. However, sparse literature is available on dye studies of extracranial head and neck vessels, even with anatomists, and the preparation of these cadavers is a daunting task. Materials and Methods In this study, we describe a straightforward technique of silicone dye injection for extracranial head and neck vasculature and its application for filler injection training and other plastic surgical procedure demonstrations on cadavers. We used six soft-embalmed cadavers. The common carotid arteries and internal jugular veins were cannulated with infant feeding tubes. The vessels that could lead to dye extravasation into intracranial vessels and upper limbs were ligated. The vasculature was irrigated with water and then injected with color-coded silicone dyes (red: arterial; blue: venous). The solvent-to-catalyst ratios were varied to identify the ideal combination. Injected specimens were dissected 24 hours later to identify the staining quality. Results A clear demarcation of the extracranial head and neck vasculature in all cadavers was seen. The best solvent-to-catalyst ratio was identified in cadavers with the best staining of both large and small-sized blood vessels (<1 mm) with no dye spillage from arteries to the veins. Conclusion Silicone dye injection with the described technique can give excellent and predictable results. The technique also uses less quantity of dye, and the intracranial structures are spared, which can be used for other studies; hence, there is more economical utilization of cadavers.

Successful Management of Parry-Romberg Syndrome With Lipografting: A Case Report

Parry-Romberg Syndrome (PRS), or progressive hemifacial atrophy, is a rare disorder marked by the progressive atrophy of skin and soft tissues, sometimes affecting muscles, cartilage, and bones. Typically manifesting in childhood, PRS has a 66% female predilection and sporadic occurrence. Diagnosis is clinical, supplemented by tests to exclude other conditions. Treatment options include bone/cartilage grafts, fat grafts, dermal fillers, and free tissue transplantation. Lipoinjection, using autologous adipose tissue enriched with stem cells, is a promising technique. A 33-year-old female with PRS exacerbated by pregnancy presented with severe right hemifacial atrophy. Initial lipoinjection elsewhere resulted in significant graft reabsorption. At our institution, a second lipoinjection was performed at age 34 after disease remission. Five months postoperatively, 30% graft reabsorption was noted, but significant improvement in facial symmetry was achieved. A second lipoinjection session further enhanced facial volume and skin quality. Four months postoperatively, the patient showed substantial improvement, with 90% facial symmetry and stable disease remission. Autologous lipoinjection is an effective treatment for PRS-related facial atrophy, offering minimal tissue rejection and satisfactory aesthetic outcomes. The presented case highlights the potential of this technique in achieving significant clinical improvement and facial symmetry in PRS patients.

Plain language summary of the pivotal study of calcium hydroxylapatite with lidocaine for improvement of jawline contour

Summary What is this article about? A study (ClinicalTrials.gov identifier: NCT03583359) that tested whether an injectable filler treatment called calcium hydroxylapatite with lidocaine, or CaHA (+), could improve the shape of the jawline.How was the study in this summary conducted? Loss of jawline shape is a change to jawline appearance, like sagging or deflating, that occurs as people get older. A total of 123 participants received CaHA (+) injections on day 1 of the study (immediate treatment). Fifty-seven participants did not receive CaHA (+) until week 12 (delayed treatment). Jawline shape at week 12 was rated on a five-point scale (0 = no loss of shape or volume; 4 = extreme loss). Researchers also looked at participants’ satisfaction and self-reported improvement, ratings of how old participants thought they looked, and side effects.What were the results of the study? In the immediate treatment group, 76% of participants had improvement in jawline shape at week 12 (compared with 9% of participants in the delayed treatment group), which typically lasted approximately 8 months, and 94% self-reported improvement in jawline appearance. The participants were more satisfied with their jawlines and reported looking approximately 3 years younger at week 12 compared with before treatment. Regardless of sex or skin tone, side effects were categorized as mostly mild or moderate reactions, like lumps or bruising, at the site where CaHA (+) was injected.What do the results of this study mean? The results showed that CaHA (+) injections improved jawline shape in most participants and caused only mild or moderate side effects regardless of sex or skin tone, suggesting that CaHA (+) is safe and works well for diverse groups of patients.Who should read this article? This summary is for patients and others interested in learning about how CaHA (+) works, its safety, and its ability to improve jawline shape.Who sponsored this study? The study was sponsored by Merz North America, Inc.

A case of bone resorption in the mentum caused by hyaluronic acid filler in a patient with skeletal Class II jaw deformity.

Chin augmentation by hyaluronic acid filler injection rarely causes abnormal bone resorption in the mentum. Thus, when taking the history of a patient with jaw deformity, it is imperative to check the history of treatment of the mentum. Hyaluronic acid (HA) filler injection is a common procedure in nonsurgical cosmetic chin augmentation. Due to its high biocompatibility and simple injection technique, HA filler injection is a popular procedure. However, adverse events such as allergic reactions and foreign body reactions have been reported in some cases. In this study, we report a case of skeletal Class II jaw deformity in which bone resorption was observed in the mentum after HA filler injection. The purpose of this study is to discuss the indications for HA filler injection in skeletal Class II cases that require orthognathic surgery. The patient was a 30-year-old woman. To improve retrusion of the mentum, she has been receiving HA filler injections in the mentum three times every 6 months in the cosmetic surgery clinic since 2015. However, the retrusion of the mentum did not improve, which prompted here to visit the orthodontic clinic. Radiographs and CT revealed bowl-shaped bone resorption surrounding the foreign bodies in the mentum. She was diagnosed with maxillary protrusion, vertical maxillary excess, mandibular retrusion, and bilateral condylar resorption. Bimaxillary orthognathic surgery (BOGS) and removal of residual HA fillers were planned after completion of the preoperative orthodontic treatment. After BOGS, the foreign bodies were completely removed, and the resorption cavities were filled with excess bone segments from the surgical sites. X-ray photoelectron spectroscopy analysis of the foreign bodies suggested the presence of HA. One year after the BOGS, no progression of condylar resorption occurred, and bone healing at the mentum had a good prognosis. Therefore, the patient underwent reduction and advancement genioplasty. She was satisfied with her facial profile and occlusal function. Unexpected bone resorption in the mentum caused by HA filler injection is often discovered incidentally. Although, patients may feel hesitant to confess their history of treatment of the mentum, it is important to ensure that they are carefully interviewed.

Comprehensive Assessment of Intradermal Responses to Hyaluronic Acid-Based Skin Injection Fillers through Multi-Pathway Dynamic Synergies

Skin injection filling products must undergo a rigorous evaluation before entering the market, and intradermal reactions are crucial for biocompatibility. However, current evaluation methods for skin injection fillers often lack precision. This study aims to explore a comprehensive evaluation method by incorporating additional indicators: dermoscopy, transepidermal water loss, moisture content, ultrasound, and histological observation. Experimental findings show sodium hyaluronate gel groups exhibited no noticeable erythema or abnormalities, except for skin swelling. The dynamic and quantitative assessment of water content and transdermal water loss provided insights into the injection site skin's edema status. Ultrasound imaging observed subcutaneous material occupation and measured skin protrusion height. Histopathological observations revealed edema and inflammation in positive groups but no significant reactions in any gel samples. The comprehensive use of these methods confirms that the intradermal response of injection fillers in this study is within an acceptable range. However, if solely evaluated based on existing standards, it may exceed the qualified range. Consequently, the study suggests that for sodium hyaluronate gel, a macromolecular injection filler for long-term subcutaneous space occupancy, the traditional intradermal reaction scoring method may be inadequate. The proposed comprehensive evaluation scheme in this study is considered a more objective approach.

Non-Surgical Medical Aesthetics and Patient Quality of Life: An Umbrella Review

Abstract Background Non-surgical cosmetic facial procedures have become popular treatment options for individuals seeking aesthetic improvements. Despite a breadth of literature on patient satisfaction with treatment outcomes, there is a lack of information specific to changes in quality of life outcomes. Objectives The objective of this umbrella review was to report the effectiveness of non-surgical facial aesthetic treatments on reported quality of life in cosmetic treatment seeking patients. We also aimed to identify gaps in the literature on measures of quality of life outside of patient satisfaction. Methods We completed a comprehensive, systematic search of review articles across six databases including Medline, CINAHL Plus, EMBASE, APA PsychINFO, Cochrane Reviews and Google Scholar. We included review-level studies examining the change in quality of life measures following treatment. Critical appraisal was completed for each review article included. Results A total of seven reviews included. One review was of strong quality, two moderate, and four were weak. Several non-surgical procedures were evaluated across reviews including injectable neurotoxins, dermal fillers and laser skin resurfacing. The majority of included studies reported increases in measures of quality of life, post treatment in the same patient or compared to controls. The most commonly reported measure was psychological wellbeing, followed by self-perception. There was a lack of measures outside of improvements to aesthetics, including those specific to mental health (e.g., depression). Conclusions Overall, studies that report on non-surgical treatments report increases in overall quality of life. This conclusion should be interpreted with caution as the majority of reviews included were of moderate to weak quality. A major gap in this literature includes mental health outcomes. Future research should focus on increasing the rigour of reporting for systematic reviews.

Decomposition and Changes in InVivo Post-HA Filler Injection: A Review.

Hyaluronic acid (HA) fillers are widely used in aesthetic medicine, but their invivo behavior and long-term effects are not fully understood. To review the decomposition and changes occurring in the body following HA filler injections, focusing on crosslinking agents, degradation processes, and tissue responses. This review analyzed oxidative and enzymatic degradation processes of HA fillers, evaluated the impact of 1,4-Butanediol Diglycidyl Ether (BDDE) crosslinking, and examined histological changes post-injection. Uncrosslinked HA degrades rapidly due to endogenous hyaluronidase, while crosslinked HA undergoes slower degradation via free radicals and hyaluronidase. Complete cross-linking (C-MoD) showed better durability compared to partially cross-linked BDDE (P-MoD). The concept of modification efficiency (MoE) was proposed to optimize filler safety and viscoelastic properties. Histological analysis revealed collagen capsule formation and autologous tissue replacement, affecting long-term outcomes. The degree of chemical modification (MoD) influences filler durability and safety, with concerns raised about potential delayed immune reactions from accumulated pendent BDDE. Clinicians should consider injection site, tissue conditions, and filler properties for safe and effective HA filler use. Emphasizing thorough BDDE removal and optimal crosslinking can enhance treatment safety and efficacy. The balance between achieving desired viscoelastic properties and minimizing potential risks is crucial. Future studies should include diverse ethnic groups to validate findings and further explore long-term tissue responses to HA fillers.

A.S.S.E.S.S. for Facial Fillers.

An in-depth and detailed facial assessment is critical in treating and achieving desirable dermal filler and neurotoxin results. An acronym called A.S.S.E.S.S. simplifies an often complex and overwhelming amount of data needed to assimilate when performing facial filler and neurotoxin injections. Applying this method to patients in six simple steps provides a starting point and offers a guideline to capture key details for a more comprehensive facial assessment. The A.S.S.E.S.S. acronym stands for animate, shape, side, external, symmetry, and shadows and is helpful in following a methodical approach in analyzing facial shape, profile, and natural facial curves in both static and dynamic states. Following a regimented A.S.S.E.S.S. approach prior to treating filler and neurotoxin patients allows providers a straightforward guide to achieve a desirable facial shape and profile. This stepwise facial assessment establishes a logical and detailed approach to ensure the important aspects of facial details are appreciated in creating reliable and pleasing filler and neurotoxin results.

The "4.3," A New Filler Lips Technique.

The "4.3" technique is a hybrid lip augmentation approach that combines the aesthetic benefits of the vertical-lip technique with the fewer entry points of the retrograde linear technique. This method aims to create natural-looking, harmonious, and defined lips using hyaluronic acid (HA)-based fillers, to enhance volume and contour. The objective of this study is to evaluate the effectiveness, safety, and reproducibility of the "4.3" technique in achieving natural lip augmentation with minimal filler volume and reduced injections. This technique is applied to improve the shape and volume of the lips while minimizing the risk of complications. The technique was applied to male and female patients with standard anatomical features who desired subtle enhancements in lip contour, projection, and volume. The procedure involved four injections in the upper lip and three in the lower lip, using a combination of retrograde linear and vertical techniques. A total of 0.7 mL of HA filler were used for each patient. The "4.3" technique achieved consistent and aesthetically pleasing results across all patients, with improvements in lip volume, shape, and definition. The reduced number of injections minimized discomfort and risk of vascular complications. The use of Tri-Hyal technology contributed to smooth, plump lips with harmonious proportions. The "4.3" technique is a standardized, intuitive, and reproducible method suitable for most patients, regardless of sex. It allows for natural-looking lip augmentation using a reduced volume of filler and fewer injections, making it a safe and effective option for enhancing lip aesthetics.

Clarification Regarding the Interpretation of Anatomical Safety Zones in Temple Filler Injections.

Clarification Regarding the Interpretation of Anatomical Safety Zones in Temple Filler Injections.

Comparison of Different Types of Poly-L-lactic Acid Microspheres In Vitro and In Vivo Studies

Abstract Background Biodegradable polymers are commonly used as dermal fillers in plastic surgery. Among these, poly-L-lactic acid (PLLA) distinguishes itself owing to its good biocompatibility, degradability, and ability to act as a collagen stimulator. Objectives In this study, the differential behavior of PLLA microspheres with varying microscopic morphology and surface hydrophilicity was investigated both in vitro and in vivo. Methods The introduction of short hydrophilic polyethylene glycol (PEG) chains into the PLLA molecule was employed to modify the morphology and enhance the surface hydrophilicity of the microspheres. The morphology and physicochemical properties of the PLLA and PLLA-b-PEG microspheres were characterized. Irregular PLLA particles, PLLA and PLLA-b-PEG microspheres were implanted into the subcutaneous tissue of rabbit models, and at 4, 26 and 52 weeks after implantation, biopsy samples were collected for hematoxylin and eosin (H&E) and Masson's trichrome staining to evaluate differences in the tissue response between different implants. Results The results of in vitro research demonstrated that while the addition of short-chain hydrophilic PEG afforded a smoother surface for the microspheres, it had no significant effect on the molecular weight and degradation rate of PLLA. The histological examination revealed that the PLLA-b-PEG microspheres exhibited enhanced biocompatibility compared to the pure PLLA microspheres, while the irregular PLLA particles showed the highest inflammatory response among the three materials. Conclusions In this study, we found that the properties of PLLA were improved upon modification by short-chain PEG without reducing the collagen regeneration ability, thereby affording a better histocompatibility.

Enhancing Athletic Recovery: Scar Treatment Using Microneedling, Dermal Fillers, and Lasers

Introduction and purpose: Scars represent a prevalent skin irregularity encountered by a significant portion of the population. Beyond merely impacting physical appearance, they can also contribute to the onset of depression and anxiety disorders, which may hinder athletic recovery. The treatment landscape for scars is diverse, spanning non-invasive to invasive procedures. This literature review endeavors to explore scar management, particularly focusing on methodologies involving microneedling, dermal fillers, and laser interventions. By examining these innovative approaches, we aim to provide insights into their efficacy and implications for clinical practice, with a particular emphasis on facilitating a faster return to sport and optimal athletic performance. Material and methods: The literature was conducted using "Pub Med" and "Google Scholar" databases with the keywords „scars”, „microneedling”, „dermal fillers”, „lasers” Brief description of the state of knowledge: Scar therapy using microneedling, dermal fillers, and lasers has shown high effectiveness and significantly improves the lives of patients undergoing treatment. Results and conclusions: Treating scars using microneedling, dermal fillers, and laser therapy has led to significant enhancements in both physical functioning and psychological well-being among patients with visible scars. These procedures exert their efficacy by promoting collagen synthesis and facilitating skin regeneration, thereby ameliorating skin redness, erythema, and scar tissue formation. However, it's important to note that the effectiveness of these interventions varies depending on factors such as the type and depth of the scar, as well as the age of the patient.

Quantitative Assessment of New Frontiers in Dermatochalasis and Periorbital Hyperpigmentation Treatment: The Role of Cross-Linked Porcine Collagen.

Collagen dermal fillers have shown efficacy in addressing age-related changes in facial appearance. However, their potential in rejuvenating the periorbital region remains unexplored. The aim of this study was to evaluate the effectiveness, clinical safety, and patient satisfaction associated with the utilization of collagen dermal fillers in individuals with dermatochalasis and periorbital hyperpigmentation. This study was reviewed and approved by the institutional review board of China Medical University Hospital (IRB No. CMUH107-REC2-157). Adults diagnosed with dermatochalasis or periorbital hyperpigmentation received periorbital injections of a sterile cross-linked highly-purified specific antigen free porcine dermal collagen (FACIALGAIN® Collagen Implant with Lidocaine, Sunmax Biotechnology Co. Ltd., Taipei, Taiwan) and were assessed for hydration, elasticity, pigmentation index, redness index, lightness value, and density with the DermaLab® Combo Multiparameter Skin Analysis System (Cortex Technology, Hadsund, Denmark) and Cutometer® Dual MPA 580 (Courage+Khazaka electronic GmbH, Köln, Germany). Data was collected prior to injection and at 1 week, 4 weeks, and 12 weeks after injection. Patient satisfaction on volume augmentation, decrease in hyperpigmentation, persistence, and overall satisfaction were also recorded. A total of 12 samples each were recruited for dermatochalasis and periorbital hyperpigmentation. For dermatochalasis subjects, hydration of the periorbital tissue significantly increased at week 1 and 4 (p = 0.011 and p = 0.015). Elasticity decreased by week 4 and persisted until week 12 (p = 0.001 and 0.014). For periorbital hyperpigmentation patients, lightness value increased significantly starting week 1 (p = 0.016), tapering off at week 12. Elasticity decreased by week 4 and persisted until week 12 (p = 0.002 and p = 0.002). Median overall patient satisfaction was 4 out of 5 for the dermatochalasis group and 4.5 out of 5 for the periorbital hyperpigmentation group, with a mild but insignificant decrease by week 12. DermaLab® Combo and Cutometer® Dual MPA 580 are considered effective methods for evaluating patients undergoing dermal filler injections. The utilization of cross-linked porcine collagen dermal filler injections can serve as a minimally invasive approach to enhance skin laxity in dermatochalasis and address discoloration in periorbital hyperpigmentation. However, it is important to note that regular treatments may be necessary to sustain the desired outcomes. 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/0026 .

The New Frontier of JAK Inhibitors: Significant Therapeutic Response to Tofacitinib in a Patient With Granulomatous Reaction to Filler in the Buttocks.

Recent research has demonstrated that Janus Kinase (JAK) inhibitors can be effective in treating refractory granulomatous diseases. We report the case of a 50-year-old woman who developed a granulomatous reaction following a filler injection in her buttocks. The patient was treated with tofacitinib, and after 1 year of therapy, the stiffness and swelling resolved without any side effects. Tofacitinib appears to be a viable option for the treatment of granulomatous reactions to fillers.

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 .