Polynucleotides HPT for Asian Skin Regeneration and Rejuvenation.

Introduction: Even lightly compromised skin may impact self-esteem and social behaviour. After intradermal infiltration, natural-origin Polynucleotides High Purification Technology (PN HPT) promote new collagen and extracellular matrix production, translating into a physiological correction of the ageing skin. The study aimed to explore the benefits of intradermal PN HPT on the four perceptual skin quality categories "Skin Tone Evenness", "Skin Surface Evenness", "Skin Firmness", and "Skin Glow" in a representative sample of 30 Asian subjects (mean age 40.2± 11.4 years old). Methods: Study protocol: three intradermal injections of a PN HPT-based Class III CE-marked medical device at T0 (baseline assessment and first treatment session), T1 (four weeks after baseline), and T2 (eight weeks after baseline), with efficacy and safety evaluations at T1, T2, T3 (four months after baseline) and T4 (six months after baseline). Quantitative and qualitative assessments: 3D skin analysis system QuantifiCare and Global Aesthetic Improvement Scale (GAIS, Investigator and Patient subscales). Results: PN HPT treatment led to a meaningful and statistically significant improvement of the skin surface, firmness, pigmentation, and radiance, with no early- or late-onset adverse events and benefits persisting up to the sixth-month visit in all subjects. At T4, 33% and 43% of treated subjects felt "Much Improved" and "Very Much Improved" (optimal result); 56% and 44% of treated subjects felt "Satisfied" or "Very Satisfied". At T4, the mean Investigator GAIS scores were 3.33 out of 5.0 for the "Skin Tone Evenness" skin quality perceptual category, 3.46 for the "Skin Surface Evenness" category, 3.61 for "Skin Firmness", and 3.45 per for the radiance determinant of the "Skin Glow" category. Conclusion: Intradermal treatment with the PN HPT-based medical device led to a meaningful improvement of the skin surface, firmness, pigmentation, and radiance with complete safety. The aesthetic benefits persisted up to the sixth-month visit in all subjects.

Self-perception of natural outcome, appearance, and emotional well-being after OnabotulinumtoxinA treatment for upper facial lines: Post hoc analysis across age and gender.

BACKGROUND: OnabotulinumtoxinA (onabotA) is indicated for upper facial lines (UFL). Fear of unnatural-looking outcomes is a frequently reported treatment barrier. AIMS: Examine patient-reported outcomes (PROs) after onabotA treatment for UFL. METHODS: A post hoc analysis was conducted on two 12-month pivotal studies of onabotA for forehead and glabellar lines (20 U each), with/without treatment of crow's feet lines (±24 U). This analysis used PROs from the Facial Line Satisfaction Questionnaire: Items 4 (natural look), 5 (treatment effect), 11 (met expectations), and Impact Domain (appearance and psychological impact). The analysis included 458 neurotoxin-naive adults achieving a ≥2-grade improvement in forehead line (FHL) severity on the Facial Wrinkle Scale at Day 30 (primary endpoint). [Corrections made on 28 December 2023, after first online publication: 'UFL' in the previous sentence has been corrected to 'forehead line (FHL)' in this version.] Data were further stratified into millennials and men. RESULTS: At Day 30, 90.5% of all participants, 94.6% of millennials, and 85.7% of men were satisfied with receiving a natural look. Millennials had higher odds of being satisfied with natural outcomes at Day 30. This measure remained > 80% for all groups throughout the 12 months. Additionally, ≥80% were satisfied with the treatment effect, and >90% reported results met expectations. At Day 30, ≥50% reported positive impacts on self-perceived appearance and psychological well-being, but millennials had higher, and men had lower odds of reporting these improvements. CONCLUSIONS: Participants achieving a ≥2-grade improvement in FHL severity after onabotA reported high satisfaction with natural outcomes and the treatment effect, with improved self-perceived appearance and psychological well-being. [Corrections made on 28 December 2023, after first online publication: 'UFL' in the previous sentence has been corrected to 'FHL' in this version.] These results may help aesthetic providers and patients address fears regarding unnatural results with onabotA.

Treating Glabellar Lines With Botulinum Toxin: Does Your Patient Need to Frown Steadily?

BACKGROUND: The variable relationship between the orbicularis supercilii and frontalis muscles may cause side effects with botulin toxin; steadily frowning is the usual recommendation. Eliminating the need to frown until all injections are over might enhance efficacy and lessen the neurotoxicity risks related to muscle exhaustion. OBJECTIVES: The goal of this study was to investigate whether the digital caliper-assessed distances between the medial and lateral corrugator injection sites and the midline differed significantly in patients persistently frowning from patients resting. METHODS: Seventy-six individuals with glabellar wrinkles treated with botulinum toxin in the authors' private practices for glabellar lines voluntarily contributed their retrospective data about the positions of injection sites. The investigators had freely chosen to inject the medial and lateral sections of the corrugator supercilii during persistent maximum frown or at rest. RESULTS: The mean differences in distances between the medial and lateral injection points and the estimated midline were clinically trivial (1.0 ± 1.28 and 1.5 ± 2.53 mm, respectively), although the distances between the relaxed and contracted medial and lateral injection sites exceeded 1.8 and 2.5 mm in 33.9% and 46.4% of patients, respectively. Distance differences, not significant before 40 years old, were statistically significant only for the lateral injections in older patients (on average, 1.9 ± 3.01 mm). CONCLUSIONS: The average distances from the medial and lateral injection points and the midline appear minimally different in patients who frown until all injections are over and, conversely, patients who rest. Persistently frowning might be advisable only in patients older than 40. Facial asymmetries may be a confounding factor.

Facial rejuvenation with the new hybrid filler HArmonyCa™: Clinical and aesthetic outcomes assessed by 2D and 3D photographs, ultrasound, and elastography.

OBJECTIVE: Facial aging is a complex process that involves genetic, biological, and environmental factors. This paper aimed to present the first aesthetic and safety outcomes of a hybrid filler that combines hyaluronic acid (HA) (20 mg/mL) and calcium hydroxyapatite (HA/CaHa). METHODS: Prospective and non-randomized interventional study conducted on consecutive healthy patients who attended the clinic for an aesthetic facial rejuvenation procedure. HA/CaHa was injected with 23G cannula (retrograde threads, 1.25 mL per side) in the preauricular region. Ultrasound examinations, elastography images, and 2D and 3D photographs were performed before and after treatment. The primary endpoint were the volumetric changes at Day 180. RESULTS: Fifteen patients were included in the study. At Day 180 after treatment, median (interquartile-range) volume increased by 2.1 (1.9-2.3) cc and 2.1 (1.8-2.2) cc in the right- and left-side, respectively, p < 0.0001 each. As compared to pretreatment values, facial-tension vectors significantly increased by 2.2 (1.6-2.2) mm and 2.0 (1.7-2.2) mm in the right and left side, respectively, p < 0.0001 each. Elastography images demonstrated an increase in collagen fibers at post-treatment Day 60, which was confirmed on Day 90, and reached the peak effect between Days 90 and 180. Regarding safety, there were no either unexpected or serious treatment-related adverse events. Most patients experienced a mild redness and inflammation that resolved within the first 48 h without treatment. CONCLUSIONS: The HA/CaHa hybrid filler (HArmonyCa™), besides its volumizing and lifting properties, was associated with an increase in the viscoelasticity, both at the level of the reticular dermis and the subcutaneous cellular tissue, which might be indicative of the formation of new collagen fibers.

Eyebrow lifting with barbed threads: A simple, safe, and effective ambulatory procedure.

INTRODUCTION: Changes in brow positioning are one of the first facial aging signs. A more beautiful and younger look can be achieved by repositioning the tissues involved in brow descent and sagging eyelids. METHODS: We report the outcome of eyebrow thread lifting in a series of patients who came to our clinic to improve their gaze. Response to treatment was assessed at 6- and 12-months using FACE-Q™ upperlids and eyebrow/forehead scales. RESULTS: A total of 38 patients with mild-to-moderate brow ptosis or without ptosis underwent eyebrow thread lifting (mean age 35.5, all female). No serious complications were observed during or after treatment. All patients were satisfied with the outcome of the intervention. Mean FACE-Q™ scores improved at six months compared with baseline. A statistically significant increase in mean FACE-Q™ scores was still seen at 12 months and was more evident in younger women. Patients were able to go back to their daily lives the day after the procedure. CONCLUSION: Eyebrow thread lifting is a minimally invasive procedure able to overcome mild-to-moderate ptosis with excellent aesthetic results. In the absence of ptosis, thread lifting is a good choice to reposition the brow and improve the gaze. The technique is simple to perform and safe.

Hyaluronic Acid Fillers, Needle Contamination by Fastidious Microorganisms, and Risk of Complications.

BACKGROUND: Complications are becoming ever more common with the increased use of hyaluronic acid (HA) fillers in aesthetic medicine. Complications due to needle contamination with fastidious microorganisms are no exception. OBJECTIVE: To perform, in a top Italian aesthetic medicine facility, what the authors think is the first monitoring program of microbial needle contamination of cross-linked HA gel fillers after the prefilled syringes with gel residues were stored for retouches after the first aesthetic procedure. METHODS: Needle contamination monitoring study, performed between January and November 2019, on 35 needles (caliber, 30 and 27 G) stored at 4°C in their resealed filler packages for possible retouch after a first aesthetic treatment involving the middle and lower facial thirds. Women's age: 35 to 70 years old. RESULTS: The search for contaminating agents of the 3 monitored bacterial contaminants ( Staphylococcus aureus , Streptococcus pyogenes , and anaerobes) as well as yeasts and molds always tested negative. In the days and months after treatment, no patients in post-treatment controls showed evidence of infection in the treated areas. CONCLUSION: The observational retrospective study confirms that good storage conditions, including monitored refrigeration, avoid the risk of contamination of partially used HA gel fillers by fastidious microorganisms.

The impact of headache symptoms in a population of Italian university students during the COVID period: an observational study based on 4926 cases.

We conducted an observational study of 4926 university students from all over Italy and different university courses, including health areas. Students were contacted through the most popular social networks and some student's course representatives also acted as intermediaries, from June 1 to August 31, 2021. A questionnaire has been carried out using "Google Forms" and MIDAS. The study confirmed how the headache was widespreaded among the student population and how much it was underestimated (only one-fifth of the interviewees had been to a specialist/headache center). The negative impact of habitual headache on school performance was confirmed by the attendance on courses and the overall study performance. The clinical phenomenon might have been impacted by the pandemic period and its changes in lifestyle, in the study methodology, and due to the stress increase. Finally, the means used in the study were very satisfactory: the use of peers of the interviewees and the social networks, obtaining a broad acceptance of the study and possibly offering a method which is likely to be used in the future. Students presenting habitual headaches must be aware of their condition and the need to search for an appropriate diagnosis and treatment.

Heterogeneous crow's feet line patterns and customized botulinum toxin rejuvenating treatment.

BACKGROUND: From early dynamic lines in smiling and squinting young people, crow's feet lines in the lateral canthal region evolve through prolonged tissue remodeling into mature, stable rhytids after the mid-to-late thirties, and requests for rejuvenating treatment. Because of the heterogeneous fanning behavior of crow's feet lines, individualizing neuromodulation with botulinum toxin injections might be a sound strategy to maximize aesthetic outcomes. AIMS: To investigate the prevalence of variable crow's feet line patterns at maximum contracture and while smiling and comment on the relative distribution of such patterns and the influence of aging. These considerations will be the basis and rationale for future studies that will individualize the total 24-unit dose according to the distribution of crow's feet lines. METHODS: Identifying CFL orientation at maximum frown and while smiling; assessment tool: the four-class 2015-version of Kane's classification further modified by converting the former "central fan pattern" into a new, more precisely defined "extended full-fan pattern" class. RESULTS: The 323 cohort subjects had a mean age of 51.5 ± 9.28 years. Although with some differences, outcomes in a central-southern real-world European Caucasian population appear similar to the distribution first studied in 2003 in a highly selected population in New England involved in double-blind clinical trials. The full-fan pattern predominated both at maximum contraction and when smiling, followed in prevalence by the upper-fan pattern at maximum contraction and the extended full-fan pattern while smiling. Age significantly influenced the crow's feet line pattern-lower-fan patterns were more frequent than other patterns in the real-world younger middle-age group (40-49 years old); full-fan and extended full-fan patterns progressively more prevalent with aging. CONCLUSIONS: The study confirms but somewhat modifies the previous evidence about the non-homogeneous distribution of crow's feet line fanning patterns in different age groups and reinforces the case to individualize the topography of botulinum toxin injections.

Botulinum Toxin Type A: Adverse Events and Management.

Aesthetic medicine is witnessing an increasing exploitation of all the procedures. The demand has never been higher than it is today. The number of practitioners is also increasing year by year. Consequently complications and other kinds of related troubles and procedures are also rising. Never like today is fundamental, in case of troubles, how to properly manage with the most frequent issues. In aesthetic medicine field, botulinum toxin procedures are the safest. Lot of patients are worried about botulinum toxin despite the available scientific literature. Rare short-term complications are observed. In the most of cases, nothing severe occurs if the international recommendations and the most recent guidelines are closely followed, the majority of them are injection related. This study is a review of rare or common problems that can occur and how to manage or solve the situations.

OnabotulinumtoxinA from lines to facial reshaping: A new Italian consensus report.

BACKGROUND: Botulinum neurotoxin type A is the most widely used nonsurgical treatment for esthetic improvement of the face and neck. In 2015, an Italian consensus panel met to discuss the optimal methods for using onabotulinumtoxinA. However, clinical practice continues to evolve and the original report is now considered obsolete. AIMS: To provide updated guidance on the esthetic uses of onabotulinumtoxinA in the face and neck. METHODS: A panel of 10 Italian specialists (including plastic and maxillofacial surgeons, dermatologists, and esthetic doctors) individually completed a questionnaire on their own clinical practice, and then met to discuss their responses and agree on a revised treatment consensus. RESULTS: Recommendations are provided on patient assessment, reconstitution of onabotulinumtoxinA, and preferred procedures (injection sites, doses, anatomical targets, safety precautions, etc.) across a variety of treatment areas, including glabellar, crow's feet, and forehead lines; brow lifting and shaping; lower eyelid hypertrophy; bunny lines; sagging nasal tip; gummy smile; masseter hypertrophy; perioral lines; marionette lines and "sad mouth;" mentalis hypertonia; and platysma bands. Some of the recommended doses are substantially increased from the previous consensus (particularly in the upper third and masseter) for the purpose of achieving longer lasting results without affecting safety. Furthermore, two increasingly popular techniques-the Nefertiti lift and Microbotox-are included in the consensus for the first time. CONCLUSIONS: Optimal practice with onabotulinumtoxinA requires a systematic approach to maximize safety and effectiveness across the range of potential uses. The present consensus was developed to support these aims.

PN-HPT® (Polynucleotides Highly Purified Technology) in facial middle third rejuvenation. Exploring the potential.

BACKGROUND: Wasting of soft tissues leads to flattening and deflation of the aging midface skin. Polynucleotides Highly Purified Technology (PN-HPT® ) demonstrated dermal hydration and elasticity as well as fibroblasts vitality and activity. AIMS: To probe the value of PN-HPT® in middle third rejuvenation in an open-design, exploratory prospective cohort study in 40 real-life ambulatorily treated women. METHODS: Three treatment sessions-at baseline (2-ml prefilled syringe containing 10 mg/ml PN-HPT® , 10 mg/ml hyaluronic acid, 200 mM mannitol) as intradermic gel, and after 3 weeks (2-ml prefilled syringe containing 20 mg/ml PN-HPT® intradermic gel) and 6 weeks (same treatment as baseline). The protocol allowed supplemental treatment with specifically formulated PN-HPT® (7.5 mg/ml) when needed in periocular and eyelid areas. ASSESSMENTS: sequential photographs of the facial middle third at baseline, third treatment session and 6-8 weeks after the third treatment session; scoring of overall skin quality and texture, skin quality determinants (wrinkles and skin roughness, skin elasticity, skin brightness), scar appearance, and subjective satisfaction with impromptu 10-cm Visual Analogue Scales. RESULTS: Significant improvement of overall skin quality and texture (from 7.0 ± 1.06 at baseline session to 7.8 ± 0.99 at follow-up), associated with highly significant improvements of wrinkles and skin roughness, elasticity, and brightness (-17.1%, +39.6%, and +51.1%, respectively). The severity scores of post-acne scars decreased from 7.6 ± 1.32 to 4.2 ± 2.13. Individual satisfaction score at the end of treatment: 0.8 ± 0.28. CONCLUSIONS: PN-HPT® candidate as a valuable option for facial middle third rejuvenation. Further trials will hopefully confirm these early results.

Mid-face reshaping using threads with bidirectional convergent barbs: A retrospective study.

BACKGROUND: Minimally invasive procedures, such as thread suspension techniques, are a growing trend for facial rejuvenation. However, not enough data are available on the efficacy, outcomes, and morbidity of suture suspension techniques in mid-face reshaping. AIMS: Our goal was to assess treatment outcomes and patient satisfaction following mid-face reshaping using threads with bidirectional convergent barbs (DefinisseTM free floating threads). PATIENTS/METHODS: We performed a retrospective analysis of 60 patients who underwent treatment for mid-face reshaping using DefinisseTM free floating threads. Response to treatment was assessed at 6 months using the mid-face-specific Mid-Face Volume Deficit scale (Allergan® ), Global Aesthetic Improvement and FACE-QTM scales. RESULTS: Sixty patients underwent mid-face treatment with the suspension thread technique (mean age 51.3, 90% female). No concomitant procedures were done. A reduction by one point or more in the Mid-Face Volume Deficit Scale (MDFVS) score treatment was seen in all patients after 6 months. Mean overall MFVDS and FACE-QTM scores were significantly improved. On the GAIS, most patients were rated as improved or better both by the evaluating investigators and during self-assessment. No major complications were observed, and none of the patients requested the removal of the threads (mean follow-up 9.8 months, range 6-14 months). CONCLUSION: Our results suggest that mid-face reshaping with DefinisseTM free floating threads is a safe and reliable procedure characterized by low complication rates and good esthetic results. This minimally invasive procedure is a good alternative for normal or combination skin patients who refuse or want to delay the need for traditional rhytidectomy.

Consensus report on the use of PN-HPT™ (polynucleotides highly purified technology) in aesthetic medicine.

BACKGROUND: Injective procedures using polynucleotides-based products to promote dermal rejuvenation and revitalization are steadily evolving, yet no structured protocols are available that discuss and provide guidance in aesthetic treatments with highly purified polynucleotides. The goal of this document was to provide consensus-based recommendations for the safe and effective use of Polynucleotides Highly Purified Technology™ (PN-HPT™) devices for skin rejuvenation. PATIENTS/METHODS: A team of eight experts with extensive experience in treatments for skin rejuvenation and revitalization integrated the best available evidence and clinical judgment and devised a series of practical guidance to support dermatologists, plastic surgeons, and aesthetic physician in the use of PN-HPT™ products, alone and in combination, in aesthetic medicine. RESULTS: For most items, the expert group achieved a majority consensus. "Recommendations" (consensus >80%) were reached for the face, periocular area, décolleté and neck, hands, scalp, and stretch marks. Recommendations include details of techniques, information on dosage, volumes to be injected, and the ideal number of required treatment sessions, as well as time intervals between them for different areas of face and body. A lower agreement level of 60% was reached on but one item related to the initial treatment cycle for the face, leading to a "Consensus statement" for that area instead of a full "Recommendation." CONCLUSION: The expert consensus illustrates the value of natural-origin, highly purified polynucleotides (PN-HPT™) as biostimulatory booster strategy for skin priming and revitalization of face and body and provides a detailed guide for the use.

Expert Consensus on Injection Technique and Area-Specific Recommendations for the Hyaluronic Acid Dermal Filler VYC-12L to Treat Fine Cutaneous Lines.

BACKGROUND: VYC-12L is a hyaluronic acid (HA) injectable gel designed to treat fine cutaneous lines and improve skin quality attributes such as hydration and elasticity. OBJECTIVE: Expert consensus was sought on VYC-12L injection technique and primary treatment target areas. METHODS: A multinational group of aesthetic medicine clinicians (n = 128) attended product training and each identified ~10 patients for VYC-12L. After treating their first and last patients, the clinicians completed a survey on preferred injection methodology/technique, including injection angle, volume, and spacing. An expert panel (n = 12) discussed survey results and their clinical experiences to obtain consensus on VYC-12L technique and appropriate treatment areas. RESULTS: Recommendations included micro-depot injections of VYC-12L into the deep dermis with a 32G ½ inch needle inserted at <45º to the skin, spaced 0.5‒1.0 cm apart, with 0.01‒0.05 mL volume per injection (full-face total volume: ~2 mL). Recommended primary treatment areas were the malar, perioral, neck, and décolletage regions. Injection techniques for different treatment areas/demographic characteristics were similar, with some variability in treatment approach. Patient selection criteria, pre- and post-treatment guidelines, and managing patient expectations are important components of treatment. CONCLUSION: These consensus recommendations may assist clinicians in optimizing the treatment of fine lines with VYC-12L.

A Topical Depigmentation Program Against Hyperpigmentation Enhances the Benefits of Previously Performed Chemical Peeling Procedures of the Face.

Chemical peeling can reduce skin hyperpigmentation; however, once exhausted its thinning action, the depigmentation process does not continue further. We carried out a monocentric, prospective, noncontrolled study aimed at the evaluation of the efficacy, safety, ease of use, pleasantness, and tolerability of a depigmentation topical treatment program in women submitted to a previous chemical peeling. The topical treatment has been administered daily for 30 days to 16 women submitted to a chemical peeling containing a fixed-dose combination of salicylic acid, pyruvic acid, and retinoic acid within 7 days before study inclusion. Target skin areas have been evaluated for melanin concentration and skin texture before peeling and at study visits 1 (after peeling) and 2 (after the 30-day treatment). The topical treatment program induced a decrease in melanin concentration between study visits 1 and 2 (-4.74%; p = 0.0008). It reduced melanin concentration even further between the prepeeling period and visit 2 (-7.8%; p < 0.0001). Patients rated the depigmentation topical treatment program as "very simple" (87.5%) and "simple" (12.5%) to use and as "pleasant" (56.25%) and "very pleasant" (43.75%). Results support the use of the home-based depigmentation topical treatment program to potentiate the effectiveness of a previous chemical peeling in hyperpigmentation reduction.

Efficacy, Patient-Reported Outcomes, and Safety in Male Subjects Treated With OnabotulinumtoxinA for Improvement of Moderate to Severe Horizontal Forehead Lines.

BACKGROUND: Men represent a growing segment of the facial aesthetic market. OBJECTIVE: To evaluate investigator-assessed efficacy, patient-reported outcomes, and safety after onabotulinumtoxinA treatment of forehead lines (FHL) in men. METHODS: Subjects with moderate to severe FHL received onabotulinumtoxinA (frontalis: 20 U; glabellar complex: 20 U, with/without 24 U in crow's feet regions) or placebo in 6-month, double-blind periods of 2 pivotal trials. Results for men were pooled. RESULTS: Men comprised 12% (140/1,178) of subjects. Day 30 male responder rates for achieving at least 1-grade Facial Wrinkle Scale (FWS) improvement at maximum eyebrow elevation and at rest were 98.2% and 93.3%, respectively; a significant difference in responder rates was maintained versus placebo (p < .05) through Day 150. Despite men having proportionately more severe FHL at baseline, 81.8% and 79.8% achieved Day 30 FWS ratings of none or mild at maximum eyebrow elevation and at rest, respectively (p < .05); significance versus placebo was maintained through Day 120. Men reported high satisfaction rates and improved psychological impacts. No new safety signals were detected. CONCLUSION: Standard dosing and administration of onabotulinumtoxinA significantly improved static and dynamic FHL appearance, despite men having proportionately more severe FHL at baseline. Men reported high satisfaction and appearance-related psychological impact improvements.

Improvements in satisfaction with skin after treatment of facial fine lines with VYC-12 injectable gel: Patient-reported outcomes from a prospective study.

BACKGROUND: VYC-12, a hyaluronic acid injectable gel, is designed to treat fine lines and provides improvements in other skin quality attributes. A prospective study demonstrated the safety and effectiveness of VYC-12 for the improvement of fine lines as measured by changes in skin texture. AIMS: To evaluate patient-reported outcomes in subjects treated intradermally with VYC-12 in the cheeks, forehead, and neck (optional) in the prospective study. METHODS: Subjects received an initial treatment of VYC-12 (N = 131), with a touch-up treatment, if deemed necessary, offered 30 days later, and optional repeat treatment 9 months after initial or touch-up treatment. Subjects completed the FACE-Q Satisfaction With Skin scale and assessed willingness to recommend treatment to a friend at baseline, months 1, 4, 6, and 9, and month 1 after repeat treatment. Subjects also evaluated their return to normal daily social activities. RESULTS: Satisfaction with skin improved from baseline in 90.8% of subjects at month 1, 88.4% at month 4, 83.6% at month 6, 76.4% at month 9, and 91.9% at month 1 after repeat treatment (P < .001, all time points). At least 94% of subjects returned to normal daily social activities one day after treatment (initial, touch-up, or repeat). More than 80% of subjects said they would recommend treatment to a friend at all time points through month 9 (97% at month 1 after repeat treatment). CONCLUSION: Treatment with VYC-12 significantly improved satisfaction with skin in the majority of subjects, with most subjects returning to normal activities 1 day after treatment.

VYC-12 Injectable Gel Is Safe And Effective For Improvement Of Facial Skin Topography: A Prospective Study.

OBJECTIVE: Evaluate safety and effectiveness of VYC-12 (Juvéderm Volite; an injectable crosslinked hyaluronic acid gel designed to improve skin quality attributes such as surface smoothness and hydration) for facial intradermal injection. MATERIALS AND METHODS: In a prospective, single-arm study, subjects with moderate/severe cheek skin roughness per Allergan Skin Roughness Scale (ASRS) received VYC-12 in the cheeks and forehead, and/or neck, with touch-up treatment to correct asymmetry 30 days later and optional repeat treatment 9 months after last treatment. The primary effectiveness measure was ASRS responder rate (percentage of cheeks with ≥1-point improvement from baseline) at month 1. Skin hydration was instrument-assessed. RESULTS: Of 131 subjects treated, 31 (23.7%) received touch-up treatment. ASRS responder rate was 96.2% at month 1, 76.3% at month 4, 34.9% at month 6, and 87.1% after repeat treatment. Responder rate in cheeks with severe baseline roughness was 93.8%, 83.1%, and 52.3% at months 1, 4, and 6, respectively. Skin hydration improved significantly (P<0.01) from baseline at all timepoints through month 9. Injection site responses were as expected. All treatment-related adverse events were mild/moderate. CONCLUSION: VYC-12 safely and effectively improved skin smoothness up to 6 months and hydration lasting 9 months.