Volume loss of the face occurs over time; thus, volume enhancement of the midface can counteract the effects of aging. Hyaluronic acid (HA) fillers are often used for facial revolumization for a more ...youthful appearance due to their favorable outcomes and safety profiles. A patient‐centric approach, in which dynamic facial expressions are considered, is needed for optimal aesthetic results. In addition, injectors must be familiar with midface anatomy, how it is affected by the aging process, and must also consider the rheological and physical properties of fillers, including their stretch and dynamic strength.
In this article, optimal injection techniques are described for a new range of HA‐based fillers for midface revolumization using a needle, cannula, or both. The layering technique involves product placement in both the deep and superficial fat compartments to achieve natural‐looking outcomes at rest and during motion.
The Resilient Hyaluronic Acid (RHA®) line of fillers was designed to maintain their durability and integrity while adapting to the dynamic movements of the face. RHA 2 is applicable for superficial placement, whereas the balanced stretch and dynamic strength of RHA 3 render it more versatile. The novel rheological properties of RHA 4, with the highest dynamic strength and sufficient stretch, allow it to be injected superficially and into deep facial compartments.
Depending on patient characteristics, the appropriate RHA filler can be chosen to reach the goal of a natural, younger appearance and avoid overfilling.
BACKGROUNDSAKURA 3 was a Phase 3, open-label, repeat-dose safety study of DaxibotulinumtoxinA for Injection (DAXI); a component of the largest Phase 3 clinical development program of an aesthetic ...neuromodulator in glabellar lines.
OBJECTIVETo evaluate the use of DAXI (40U) up to 3 treatments for moderate or severe glabellar lines.
METHODSEligible subjects rolled over from the placebo-controlled trials (n = 477) or were de novo (n = 2,214) and received 1 to 3 treatments over a maximum of 84 weeks. Safety and efficacy were evaluated at least every 4 weeks up to Week 36 (Treatments 1 and 2) and Week 12 (Treatment 3). Select subjects could be retreated after Week 12 if glabellar lines returned to baseline.
RESULTSSafety results are reported for 2,691 subjects, of which 882 received a second treatment and 568 a third. Treatment-related adverse events (AEs) occurred in 17.8% of subjects, which were generally mild and resolved. No serious AEs were treatment-related. Eyelid ptosis occurred in 0.9% of treatments. Adverse events were consistent across treatments and no new safety signals were observed.
CONCLUSIONThe safety of DAXI in this large open-label safety study confirms the findings from the pivotal Phase 3 trials, providing reassurance in its overall safety profile.
DaxibotulinumtoxinA for Injection (DAXI) is a novel botulinum toxin type A formulation approved for the treatment of glabellar lines. The efficacy, safety, and extended duration of response of DAXI ...40 U for glabellar lines were demonstrated in 2 Phase 3, randomized, double-blind studies (SAKURA 1 and 2) and a Phase 3 open-label trial (SAKURA 3).
The aim of this study was to evaluate the efficacy and safety of the first DAXI 40 U treatment received in SAKURA 1, 2, or 3 across age and race subgroups.
Adults with moderate-to-severe glabellar lines (Investigator Global Assessment-Frown Wrinkle Severity IGA-FWS and Patient FWS PFWS scales) were evaluated for glabellar line severity for ≤36 weeks after the first DAXI treatment. Efficacy and safety were analyzed by age (18-45, >45-55, and >55 years) and race (Asian, Black and African American, and White).
Overall, 2785 patients were included in the efficacy analysis. The proportion of patients achieving none or mild glabellar line severity at maximum frown (IGA-FWS) after DAXI treatment was high in all age and race subgroups (>96% at Week 4). Glabellar line severity of none or mild by composite IGA-FWS and PFWS rating was maintained for a median of 24.0 weeks in all age subgroups, and for 27.0, 25.3, and 24.0 weeks in the Asian, Black and African American, and White subgroups, respectively. Treatment-emergent adverse events were similar across all subgroups.
Consistent with the overall study population, DAXI 40 U demonstrated a high response rate and duration of effect of ≥24 weeks across all age and race subgroups.
Background
Injectables that behave similarly to native tissue and preserve facial expressiveness represent a new frontier in aesthetic medicine. A range of fillers made of high molecular weight ...hyaluronic acid (HA) chains with low crosslinking have been specifically developed to complement facial dynamics.
Aims
The efficacy and safety of one of these resilient HA fillers, and its noninferiority to an effective comparator available in the US, were tested in the treatment of dynamic wrinkles.
Methods
A 15‐month, prospective, multicenter, controlled, randomized, double‐blind, within‐subject (split‐face) clinical trial was conducted on 140 subjects with moderate‐to‐severe nasolabial folds (NLF). Study endpoints included improvement on a proprietary Wrinkle Severity Rating Scale (WSRS) and Global Aesthetic Improvement Scale, according to Blind Live Evaluators (BLE), subjects, and treating investigators (TI). Subject perception was evaluated with FACE‐Q and satisfaction scales.
Results
The per‐protocol population included 88 subjects (92% women) of all Fitzpatrick phototypes, with a mean age of 57 years. WSRS improvement was significantly greater with the resilient HA than its comparator over 15 months, including at week 24 (primary endpoint), as rated by BLE and TI. Results demonstrated the noninferiority of the resilient HA filler to its comparator. Aesthetic improvement and subject satisfaction were durably high, with an overall trend toward higher scores for the resilient HA filler. Both treatments were safe and well tolerated.
Conclusion
The resilient HA filler made of long chains lightly crosslinked is at least equivalent to a well‐established comparator for the correction of NLF in subjects of diverse skin phototypes.
Abstract
Background
The impact of facial aesthetic treatments not only enhances physical appearance but also psychological well-being. Accordingly, patient-reported outcomes are increasingly utilized ...as an important measure of treatment success. Observer-reported outcomes are a relevant yet often overlooked measure of treatment benefit.
Objectives
The authors aimed to evaluate the impact of panfacial aesthetic treatment on the perception of an individual in a variety of social contexts.
Methods
A total 2000 men and women (aged 18-65 years) participated in an online study designed to capture the blinded observer’s social perception of pretreatment and posttreatment patients who received panfacial aesthetic treatment in the HARMONY study. Perceptions relevant to character traits, age, attractiveness, and social status were evaluated. Observers were divided into 2 groups. Single image respondents (n = 1500) viewed 6 single, randomized patient images (3 pretreatment, 3 posttreatment), and paired image respondents (n = 500) viewed 6 pretreatment and posttreatment image pairs.
Results
Single image respondents reported significantly (P < 0.05) higher levels of agreement that posttreatment subjects appeared to possess more positive character traits (eg, healthy and approachable), were more socially adept, younger, more attractive, more successful at attracting others, and possessed a higher social status. Paired image respondents also reported a higher level of agreement for posttreatment images being aligned with positive character traits, representative of a younger and more attractive individual, and one with a higher social status.
Conclusions
The results suggest that the positive impact of minimally invasive panfacial treatment extends beyond enhancing physical appearance and highlights the importance of social perception and observer-reported outcomes in aesthetic medicine.
Background: Acne vulgaris (acne) is the most common dermatologic disease seen in a racially, geographically, politically, culturally, and socioeconomically diverse Hispanic population. Despite their ...growing demographics in the US, there are few studies evaluating acne treatment in this population. Potential for skin irritation and dryness, as well as pigmentary changes are key concerns. The first lotion formulation of tretinoin was developed using novel polymerized emulsion technology to provide an important alternative option to treat these acne patients who may be sensitive to the irritant effects of other tretinoin formulations.
Objective: To determine the efficacy and safety of tretinoin 0.05% lotion in treating moderate-to-severe acne in a Hispanic population.
Methods: Post hoc analysis of two multicenter, randomized, double-blind, vehicle-controlled Phase 3 studies in moderate or severe acne. Hispanic subjects (aged 11 to 50 years, N=766) were randomized (1:1) to receive tretinoin 0.05% lotion or vehicle, once-daily for 12 weeks. Efficacy assessments included changes in baseline inflammatory and noninflammatory lesions and treatment success (at least 2-grade reduction in Evaluator’s Global Severity Score EGSS and clear/almost clear). Safety, adverse events (AEs), and cutaneous tolerability were evaluated throughout using a 4-point scale where 0=none and 3=severe.
Results: At week 12, mean percent reduction in inflammatory and noninflammatory lesion counts were 60.1% and 53.0%, respectively, compared with 51.1% and 38.7% with vehicle (P≤0.001) in the Hispanic population. Treatment success was achieved by 19.6% of subjects by week 12, compared with 12.7% on vehicle (P=0.015). The majority of AEs were mild and transient. There were four serious AEs (SAEs) reported (two each group) unrelated to treatment. Incidence of treatment-related AEs with tretinoin 0.05% lotion was lower than in the overall study population; the most frequently were application site pain (2.0%), dryness (1.4%), and erythema (1.2%). Local cutaneous safety and tolerability assessments were generally mild-to-moderate at baseline and improved by week 12. There were slight transient increases in scaling and burning over the first four weeks. Hyperpigmentation severity reduced progressively with treatment.
Conclusions: Tretinoin 0.05% lotion was significantly more effective than its vehicle in achieving treatment success and reducing inflammatory and noninflammatory acne lesions in a Hispanic population. The new lotion formulation was well-tolerated, and all treatment-related AEs were both mild and transient in nature.
J Drugs Dermatol. 2019;18(1):32-38.
Abstract
Background
A global approach to facial rejuvenation involves multiple treatment modalities.
Objectives
The aim of this study was to evaluate the impact of multimodal facial aesthetic ...treatment on self-reported psychological and social outcomes.
Methods
HARMONY, a prospective, multicenter, 4-month study, enrolled patients aged 35 to 65 years to receive on-label treatment with a combination of hyaluronic fillers (VYC-20L, HYC-24L, and/or HYC-24L+), onabotulinumtoxinA, and bimatoprost. Fillers were injected on Day 1, with touch-ups performed on Day 14. OnabotulinumtoxinA was injected at Month 3 into glabellar lines and/or crow’s feet lines. Patients applied bimatoprost to eyelashes once daily for 17 weeks. Mean change from baseline on FACE-Q Psychological Well-being and Social Confidence Scales, FACE-Q Aging Appearance Appraisal Scale, and FACE-Q Age Appraisal Visual Analog Scale were assessed.
Results
Of 100 patients treated, 93 were evaluated at 4 months posttreatment. Significant improvement vs baseline was observed on the FACE-Q Scales for Psychological Well-being (mean change, −19.9; P < 0.00001), Social Confidence (mean change, −18.2; P < 0.00001), and Aging Appearance (mean change, −28.5; P < 0.0001). On average, patients’ self-assessed age was 0.1 years older than actual age at baseline and 4.5 years younger at Month 4 (P < 0.001 vs baseline). Forty-two patients experienced adverse events, all mild to moderate.
Conclusions
Multimodal, full facial aesthetic treatment improves patients’ self-reported psychological well-being, social confidence, aging appearance, and perceptions of chronologic age.
Level of Evidence: 4
Abstract
Background
Individuals seeking aesthetic treatment have concerns regarding multiple facial areas.
Objectives
Assess the aesthetic impact and satisfaction achieved with a multimodal approach ...to aesthetic treatment using a combination of minimally invasive treatments.
Methods
Prospective, multicenter, rater-blinded, 4-month HARMONY study evaluated patient satisfaction and aesthetic impact of a combination of fillers (VYC-20L, HYC-24L, and HYC-24L+), onabotulinumtoxinA, and bimatoprost. Males and females aged 35 to 65 years received on-label, staged treatment with fillers, as needed per investigator assessment, on day 1, with touch ups allowed on day 14. Bimatoprost was self-administered once daily for 17 weeks. OnabotulinumtoxinA was injected into glabellar lines, crow’s feet lines, or both at month 3. Primary effectiveness measure was mean change from baseline on the FACE-Q 10-item Satisfaction with Facial Appearance Overall Scale.
Results
Of 100 patients treated, 93 underwent at least the 4-month posttreatment assessment and were assessed for efficacy. The FACE-Q Satisfaction with Facial Appearance Overall Scale total score increased from baseline (41.2) to month 4 (72.9; P < 0.00001; effect size, 2.7). Improvement following multimodal treatment was observed on FACE-Q individual items. Self-perceived age decreased from 0.2 years older than actual age at baseline to 4.6 years younger at month 4. Nearly all patients (99%) rated themselves as improved or much improved on the Global Aesthetic Improvement Scale. Investigator assessments also demonstrated improvement. Mild to moderate adverse events occurred in 42 patients.
Conclusions
Minimally invasive, multimodal treatment resulted in improvements in FACE-Q scores and perceived age, indicating a high degree of patient satisfaction and a younger facial appearance.
Level of Evidence: 4
Abstract
Background
VYC-15L (Juvéderm Volbella XC) is a nonanimal crosslinked hyaluronic acid (HA) gel with lidocaine.
Objectives
To evaluate safety and effectiveness of repeat treatment with VYC-15L ...administered 1 year after treatment for lip and perioral enhancement.
Methods
In this prospective multicenter study, 124 subjects with minimal, mild, or moderate lip fullness on the validated 5-point Allergan Lip Fullness Scale (LFS) who received initial/touch-up treatment with VYC-15L received repeat treatment with VYC-15L 1 year after initial treatment. Effectiveness endpoints included LFS responder rates (≥1-point improvement from baseline) and scores on the FACE-Q Satisfaction With Lips and Appraisal of Lip Lines scales at 1 month after repeat treatment. Subjects completed safety diaries for 30 days after repeat treatment.
Results
LFS responder rates were 86.2%, 80.3%, and 65.3% at months 1 and 3 and 1 year, respectively, after initial/touch-up treatment. The responder rate improved to 94.3% 1 month after repeat treatment with VYC-15L and required less median volume vs initial/touch-up treatment (1.5 vs 2.6 mL). FACE-Q scores doubled from baseline at 3 months, remained high through 1 year, and doubled from baseline after repeat treatment. At 1 month after repeat treatment, 96.7% and 89.3% of subjects showed improvement over baseline in FACE-Q Satisfaction With Lips and Appraisal of Lip Lines, respectively. Severe injection site responses were less frequent after repeat treatment than initial/touch-up treatment.
Conclusions
Repeat treatment with VYC-15L at 1 year was safe and effective for lip and perioral enhancement, and required less product volume to achieve similar effectiveness to initial/touch-up treatment.
Level of Evidence: 4
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