Safety and Effectiveness of VYC-15L, a Hyaluronic Acid Filler for Lip and Perioral Enhancement: One-Year Results From a Randomized, Controlled Study

Background:The majority of aesthetic treatments today are nonsurgical or minimally invasive aesthetic procedures. Soft-tissue augmentation with hyaluronic acid (HA) is one of them. Lip fullness and definition are key aesthetic factors associated with attractiveness, which is the reason that lip augmentation with HA fillers has become so popular.Objective: To provide a systematic review of published medical literature on the effectiveness and safety of different HA fillers used to enhance overall lip fullness. Methods and materials:The literature search was conducted according to the Preferred Reporting Items for Systematic Reviews and Meta-Analyses (PRISMA) guidelines. Twenty-two studies were included in the qualitative synthesis, 9 of them with level of evidence (LOE) 1b (randomized controlled trials), 1 with LOE 2b (individual cohort study), and 12 with LOE 4 (case series, poor-quality cohort, and case-control studies). A total number of subjects included in all studies were 3965. Results:Hyaluronic acid fillers turned out to be an effective and safe treatment. The assessment methods (especially for efficacy) varied greatly from one study to another. Observed responses to the treatment in studies using different lip fullness scales varied between 71% and 93.2%. The most common adverse events were local reactions at the injection sites (swelling, contusion, bruising, pain, redness, and itching). Conclusion:Based on the results of the studies included in this systematic review, HA fillers are effective and safe to use. The majority of included subjects were satisfied with the result and their looks. K E Y W O R D S efficacy, filler, hyaluronic acid, lips, safety

Section: Resultsmentioning

confidence: 99%

“…In four randomized controlled studies, the authors defined severity and duration of AEs. Most subjects reported treatment‐related AEs as mild (range 71%‐88%) or moderate (range 11%‐16%) in severity.…”

Section: Resultsmentioning

confidence: 99%

Effectiveness and safety of hyaluronic acid fillers used to enhance overall lip fullness: A systematic review of clinical studies

Stojanovič

Majdič

2019

“…The duration of effects for hyaluronic acid fillers has been reported at 3 to 12 months, 1 year,18 months, and 2 years . A recent study of the use of injectable hyaluronic acid gel to correct volume loss of facial temporal fossa showed that the effects of the gel persisted at least 12 months in 98% of subjects .…”

Section: Discussionmentioning

confidence: 99%

A multi‐center, open‐label, pilot study of allograft adipose matrix for the correction of atrophic temples

Gold

Kinney

Kaminer

et al. 2020

Background Autologous fat grafting (AFG) and synthetic fillers are currently used in esthetic and reconstructive surgery. Challenges in AFG include inconsistent graft retention, donor site morbidities, insufficient harvest, and excessive harvesting times. An allograft adipose matrix (AAM) has been developed as an off‐the‐shelf alternative to AFG and synthetic fillers. Aims To evaluate the clinical safety and retention of an AAM over 24 weeks after treatment of bilateral atrophic temples. Patients/Methods Ten subjects (nine females, one male, aged 47‐69 years) with temple atrophy were enrolled in the IRB‐approved study. AAM (Renuva®, MTF Biologics, Edison, NJ) was injected (<3 mL) bilaterally into the atrophic temples of each subject. Volume retention, global improvement, and safety were evaluated at 1, 4, 8, 12, 16, 20, and 24 weeks. Biopsy specimens were obtained for adipogenic and angiogenic histological evaluation. Results The mean temple volume improved over the baseline and was retained throughout the study period. Fullness (measure of volume) increased immediately from 0 pretreatment to 2.8 post‐treatment (scale 0‐4 = none‐maximum). Fullness varied from 0.8 to 2.2 from weeks 1 through 12 and was 2.7‐3.0 from weeks 16‐24, around 75% increase from baseline. Furthermore, skin tone, smoothness, texture, and overall appearance also improved with 71% of subjects being satisfied to very satisfied with the results. Adverse events were minimal and histology revealed native tissue incorporation and remodeling. Conclusion AAM is safe and well tolerated, provides at least 6‐month volume retention, improves skin quality, and supports adipose tissue remodeling after treatment into temples.

“…Because the lips and perioral regions experience constant movement, selecting a product suitable for this area is crucial for achieving a natural‐looking result. Multiple studies have proven the efficacy and safety of different HA filler products for lip and perioral injection, such as nonanimal stabilized HA, or NASHA (Restylane® Vital and Restylane® Silk, Galderma); Hyacross HA (Juvederm® Ultra and Ultraplus, Allergan); and Vycross HA (Juvéderm® Volift™, Volbella™, and Volite™, Allergan) 8‐13 . Other HA products commonly used for lip augmentation or enhancement include Restylane® Refyne™ and Restylane® Kysse™ (Galderma); Stylage® LIPS (Vivacy); and Beletero ® Shape or Beletero ®Contour (Merz).…”

Section: Product Selectionmentioning

confidence: 99%

Classifications and injection strategy for lip reshaping in Asians

Peng

2020

Filler injections have become very popular in recent decades. Of the various injection procedures, lip injection is an important aspect of filler injection, especially for Caucasian patients. Asians tend to have fuller lips than Caucasians, necessitating a different approach to lip injection. Classification systems for the lip for aesthetic treatment purposes can help a physician assess a patient accordingly, and a simple classification of Asian lips into four types for injection approaches is proposed in this paper. Each patient type is discussed in terms of trait and categorization, injection area, injection techniques, injection goals, and sample patients with treatment results.