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1.
Aesthet Surg J ; 44(4): 412-420, 2024 Mar 15.
Article in English | MEDLINE | ID: mdl-37556827

ABSTRACT

BACKGROUND: People of color (POC) are often underrepresented in clinical studies evaluating the safety and effectiveness of aesthetic products, including hyaluronic acid (HA) fillers, for which there is to date limited clinical data in POC. OBJECTIVES: The aim of this study was to assess the safety and effectiveness of a new line of dynamic resilient HA fillers (RHA; Revance, Nashville, TN) for treating moderate-to-severe nasolabial folds (NLFs) in POC vs non-POC. METHODS: Post hoc subgroup analyses compared the efficacy and safety of POC vs non-POC subjects treated with RHA2, RHA3, or RHA4 for correction of moderate-to-severe NLFs in the pooled per-protocol population (N = 217) in 2 clinical trials. Evaluated population cohorts were classified by Fitzpatrick skin type (FST) (high FST [IV-VI] vs low FST [I-III]) and by subject-reported race (non-White vs White) relative to baseline at 6, 9, 12, and 15 months. RESULTS: POC consistently showed greater improvement in wrinkle severity and higher responder rates compared with non-POC, which reached statistical significance at several measured time points. Global Aesthetic Improvement Scale scores and subject satisfaction ratings were similar for POC and non-POC and remained high throughout the course of the study. Treatment-related adverse event rates were generally lower for high FSTs vs low FSTs, with no reported cases of keloidal scarring. CONCLUSION: The RHA line of dynamic fillers is well tolerated and effective for the correction of moderate-to-severe NLFs in POC and can be confidently used in this important and growing patient population.See the abstract translated into Hindi, Portuguese, Korean, German, Italian, Arabic, Chinese, and Taiwanese online here: https://doi.org/10.1093/asj/sjad251.


Subject(s)
Cosmetic Techniques , Dermal Fillers , Skin Aging , Humans , Hyaluronic Acid , Dermal Fillers/adverse effects , Nasolabial Fold , Cosmetic Techniques/adverse effects , Skin Pigmentation , Treatment Outcome
2.
Aesthet Surg J ; 2024 Aug 14.
Article in English | MEDLINE | ID: mdl-39141784

ABSTRACT

BACKGROUND: A randomized study was previously reported to demonstrate the safety and efficacy of hyaluronic acid filler VYC-25L for restoring jawline definition. OBJECTIVES: Evaluate patient-reported outcomes (PROs), objective changes in jawline profile, and safety and effectiveness measures by Fitzpatrick Skin Phototype (FST), gender, and age following VYC-25L treatment. METHODS: Adults were randomized to receive VYC-25L (n=157) or no treatment (control; n=49) for 6 months. PROs were assessed by FACE-Q Satisfaction with Lower Face and Jawline, FACE-Q Appraisal of Lines: Marionette, and participant satisfaction with treatment questionnaires. Changes in jawline profile linear depth and volume were calculated using 3D digital image analysis. Responder rates, PROs, and injection site responses (ISRs) were assessed by FST, gender, and age. RESULTS: At month 6, >70% of treated participants responded "somewhat/very satisfied" to FACE-Q Satisfaction with Lower Face and Jawline questions, and ≥78% of treated participants responded "satisfied/definitely satisfied" with treatment overall. For participants treated in the marionette lines, the FACE-Q Appraisal of Lines: Marionette questionnaire mean score improved by 32.6 (baseline to month 6). Mean change in linear depth in the prejowl sulcus in the treatment vs control groups was 4.6 mm vs 2.5 mm, respectively, and for jawline volume was 6.0 cc and -2.6 cc, respectively, (baseline to month 6). Subanalyses showed similar outcomes by FST, gender, and age except for a numerically higher ISR incidence in females vs males. CONCLUSIONS: Treatment with VYC-25L to improve jawline definition yielded high patient satisfaction, objective improvements in jawline profile, and comparable effectiveness across various demographics.

3.
Aesthet Surg J ; 43(2): 205-214, 2023 02 03.
Article in English | MEDLINE | ID: mdl-36087303

ABSTRACT

BACKGROUND: 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). OBJECTIVES: 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. METHODS: 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). RESULTS: 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. CONCLUSIONS: 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.


Subject(s)
Botulinum Toxins, Type A , Neuromuscular Agents , Skin Aging , Adult , Humans , Middle Aged , Forehead , Injections , Double-Blind Method , Immunoglobulin A , Treatment Outcome
4.
Aesthet Surg J ; 42(8): 920-934, 2022 08 01.
Article in English | MEDLINE | ID: mdl-35039828

ABSTRACT

Midface rejuvenation is among the most valuable indications of hyaluronic acid dermal fillers, because malar projection and full upper cheeks significantly contribute to a youthful appearance. Hyaluronic acid fillers have evolved over the past 2 decades to meet specific clinical needs such as strong projection capacity and adaptability to facial dynamism. As a result, they now represent the treatment of choice for midface rejuvenation throughout age ranges by offering the potential for noninvasive treatment, immediate results, and minimal downtime. Because the 5-layered structure of the midface plays a central role in the human face, injecting the midface area may also indirectly improve other aesthetic concerns such as infraorbital hollowing and nasolabial folds. Nonetheless, midface rejuvenation requires a tailored treatment approach and a thorough knowledge of anatomy to minimize procedural risks and achieve natural-looking results. This article provides an extensive anatomical description of the midface and of the usual course and depth of vascular structures circulating nearby to delineate a treatment area and minimize procedural risks. Furthermore, considering the differential mobility and mechanical constraints of each layer of the midface, a multilayer treatment algorithm is proposed for adapting the treatment strategy to patient specificities (including age, gender, skin type, and morphology). Emphasis is also placed on desirable filler properties to create deep structural support on the one hand and accompany facial movement on the other hand.


Subject(s)
Cosmetic Techniques , Dermal Fillers , Skin Aging , Adenosine Triphosphate , Humans , Hyaluronic Acid , Nasolabial Fold , Rejuvenation
5.
Aesthet Surg J ; 42(2): NP115-NP124, 2022 01 12.
Article in English | MEDLINE | ID: mdl-33751048

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.


Subject(s)
Cosmetic Techniques , Skin Aging , Aging , Esthetics , Humans , Hyaluronic Acid , Infant , Patient Satisfaction , Prospective Studies , Treatment Outcome
6.
Dermatol Surg ; 47(1): 42-46, 2021 01 01.
Article in English | MEDLINE | ID: mdl-32773447

ABSTRACT

BACKGROUND: SAKURA 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. OBJECTIVE: To evaluate the use of DAXI (40U) up to 3 treatments for moderate or severe glabellar lines. METHODS: Eligible 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. RESULTS: Safety 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. CONCLUSION: The 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.


Subject(s)
Botulinum Toxins, Type A/therapeutic use , Forehead , Neuromuscular Agents/therapeutic use , Skin Aging/drug effects , Adult , Aged , Aged, 80 and over , Botulinum Toxins, Type A/adverse effects , Female , Humans , Injections , Male , Middle Aged , Neuromuscular Agents/adverse effects
7.
J Drugs Dermatol ; 20(1): 23-29, 2021 01 01.
Article in English | MEDLINE | ID: mdl-33400414

ABSTRACT

BACKGROUND: Absorbable suspension sutures are an effective nonsurgical modality for correction of ptosis and tissue repositioning in the face and neck. The PLLA/PLGA suture is entirely absorbable and has a dual effect in that it both lifts tissues and induces collagenesis, thereby restoring contour. In clinical practice, nonsurgical modalities are rarely used in isolation, and combination treatments with fillers, neuromodulators, lipolysis, and energy-based devices are common. OBJECTIVES: The aim of this study was to share the authors’ extensive experience in safely combing absorbable suspension sutures with other modalities in order to achieve optimal aesthetic outcomes for patients. The current work provides guidance to physicians who wish to incorporate absorbable suspension sutures into their aesthetics practice. METHODS: The authors discuss patient selection and expectation setting, rationale for selection and ordering of treatments, and optimal treatment spacing. Technologies discussed include fillers, neuromodulators, microfocused ultrasound with visualization (MFU-V), radiofrequency, lasers and intense pulsed-light (IPL), microneedling, and lipolysis. RESULTS: The authors share their approaches for combining nonsurgical techniques and present case studies illustrative of outcomes achievable through combination treatment with absorbable suspension sutures. The technical considerations for safely combining treatments such that optimal additive or synergistic benefit is reached for a particular patient are discussed. CONCLUSIONS: By combining nonsurgical modalities that address each of the four Rs (Repositioning tissue, Relaxation of hyperkinetic musculature, Resurfacing, and Revolumization),1 nonsurgical patient outcomes can be further improved. Absorbable suspension sutures represent a unique technology in that they are able to provide significant support to ptotic tissue in the face and neck. J Drugs Dermatol. 2021;20(1):23-29. doi:10.36849/JDD.5684.


Subject(s)
Dermal Fillers/administration & dosage , Rhytidoplasty/methods , Suture Techniques/instrumentation , Sutures , Combined Modality Therapy , Esthetics , Female , Humans , Middle Aged , Neck , Patient Satisfaction , Patient Selection , Practice Guidelines as Topic , Rejuvenation , Rhytidoplasty/instrumentation , Rhytidoplasty/standards , Skin Aging , Treatment Outcome
8.
Aesthet Surg J ; 41(10): 1107-1119, 2021 09 14.
Article in English | MEDLINE | ID: mdl-33325497

ABSTRACT

The normal course of aging alters the harmonious, symmetrical, and balanced facial features found in youth, not only impacting physical attractiveness but also influencing self-esteem and causing miscommunication of affect based on facial miscues. With this evidence-based paper, the authors aim to provide a comprehensive overview of the latest research on the etiology and progression of facial aging by explaining the aging process from the "inside out," that is, from the bony platform to the skin envelope. A general overview of the changes occurring within each of the main layers of the facial anatomy is presented, including facial skeleton remodeling, fat pad atrophy or repositioning, changes in muscle tone and thickness, and weakening and thinning of the skin. This is followed by an in-depth analysis of specific aging regions by facial thirds (upper, middle, and lower thirds). This review may help aesthetic physicians in the interpretation of the aging process and in prioritizing and rationalizing treatment decisions to establish harmonious facial balance in younger patients or to restore balance lost with age in older patients.


Subject(s)
Face , Skin Aging , Adipose Tissue , Adolescent , Aged , Aging , Esthetics , Humans
9.
Aesthet Surg J ; 41(12): 1409-1422, 2021 11 12.
Article in English | MEDLINE | ID: mdl-33944905

ABSTRACT

BACKGROUND: PrabotulinumtoxinA is a 900-kDa botulinum toxin type A produced by Clostridium botulinum. OBJECTIVES: The authors sought to investigate the safety of prabotulinumtoxinA for treatment of glabellar lines. METHODS: This was a multicenter, open-label, repeat-dose, 1-year phase II safety study. Adults with moderate to severe glabellar lines at maximum frown, as assessed by the investigator on the validated 4-point photonumeric Glabellar Line Scale (0 = no lines, 1 = mild, 2 = moderate, 3 = severe), were enrolled. On day 0, patients received an initial treatment of 20 U prabotulinumtoxinA (4 U/0.1 mL freeze-dried formulation injected into 5 target glabellar sites). On and after day 90, patients received a repeat treatment (RT) if their Glabellar Line Scale score was ≥2 at maximum frown by investigator assessment. Safety was evaluated throughout the study. RESULTS: The 352 study patients received a median total dose of 60 U, that is, 3 treatments per year. Fifty-one patients (14.5%) experienced adverse events (AEs) assessed as possibly study drug related; 11.1% experienced study drug-related AEs after the initial treatment. With each RT, progressively lower percentages of patients experienced study drug-related AEs. Six patients (1.7%) experienced study drug-related AEs of special interest: 3 eyelid ptosis (0.9%), 2 speech disorder (0.6%), and 1 blepharospasm (0.3%). Seven patients (2.0%) experienced serious AEs; none were study drug related. Of the 2393 samples tested, 2 patients (0.6%) tested positive for antibotulinum toxin antibodies at a single postbaseline visit. CONCLUSIONS: The safety of RTs of 20 U of prabotulinumtoxinA for moderate to severe glabellar lines was first established in this early phase II study based on a broad range of outcomes.


Subject(s)
Botulinum Toxins, Type A , Neuromuscular Agents , Skin Aging , Adult , Botulinum Toxins, Type A/adverse effects , Double-Blind Method , Forehead , Humans , Treatment Outcome
10.
J Drugs Dermatol ; 18(1): 32-38, 2019 01 01.
Article in English | MEDLINE | ID: mdl-30681791

ABSTRACT

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.


Subject(s)
Acne Vulgaris/drug therapy , Facial Dermatoses/drug therapy , Keratolytic Agents/therapeutic use , Tretinoin/therapeutic use , Acne Vulgaris/ethnology , Acne Vulgaris/pathology , Administration, Cutaneous , Adolescent , Adult , Child , Double-Blind Method , Drug Administration Schedule , Facial Dermatoses/pathology , Female , Hispanic or Latino , Humans , Keratolytic Agents/administration & dosage , Male , Middle Aged , Randomized Controlled Trials as Topic , Severity of Illness Index , Skin Cream/administration & dosage , Skin Cream/therapeutic use , Treatment Outcome , Tretinoin/administration & dosage , Young Adult
11.
J Drugs Dermatol ; 18(9): 870-877, 2019 Sep 01.
Article in English | MEDLINE | ID: mdl-31524342

ABSTRACT

BACKGROUND: ATX-101 (deoxycholic acid) causes adipocytolysis when injected into subcutaneous fat. OBJECTIVE: Evaluate the long-term safety and efficacy of ATX-101 for submental fat (SMF) reduction. METHODS: Adults (N=165) with moderate-to-extreme SMF received ≤6 treatments of open-label ATX-101 (2 mg/cm2) and were evaluated up to 12 months after last treatment. Efficacy end points included improvements in SMF based on clinician or subject assessment, patient-reported outcomes, downtime (via subject questionnaire), and skin laxity. Safety was evaluated throughout the study. RESULTS: Twelve weeks after last treatment, most subjects achieved a ≥1-grade improvement in SMF based on clinician (86.8%) or subject (83.8%) evaluation; at 12 months, 90.4% and 80.7% of these responders, respectively, maintained the response. Overall, 84.9% of subjects were satisfied with the appearance of their face/chin. At 12 months, 82.9% of subjects had unchanged, and 10.1% had improved, skin laxity relative to 12 weeks after last treatment. Adverse events were mild to moderate and mainly involved the treatment area. During the 7 days after the first treatment, 13.3% of subjects missed work and 33.9% missed social/leisure activities. Following subsequent treatments, 2.4%­6.0% of subjects missed work and 10.0%­15.7% missed social/leisure activities. CONCLUSION: The safety and efficacy of ATX-101 were sustained over 12 months. ClinicalTrials.gov identifier, NCT01426373 J Drugs Dermatol. 2019;18(9):870-877.


Subject(s)
Cosmetic Techniques , Deoxycholic Acid/administration & dosage , Lipolysis/drug effects , Subcutaneous Fat/drug effects , Adult , Chin , Female , Follow-Up Studies , Humans , Injections, Subcutaneous , Male , Middle Aged , Patient Satisfaction , Subcutaneous Fat/metabolism , Treatment Outcome
12.
Aesthet Surg J ; 39(4): 413-422, 2019 03 14.
Article in English | MEDLINE | ID: mdl-29506034

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.


Subject(s)
Cosmetic Techniques , Dermal Fillers/administration & dosage , Hyaluronic Acid/administration & dosage , Lip , Adult , Aged , Cosmetic Techniques/adverse effects , Dermal Fillers/adverse effects , Female , Follow-Up Studies , Humans , Lidocaine/administration & dosage , Male , Middle Aged , Patient Satisfaction , Prospective Studies , Young Adult
13.
Aesthet Surg J ; 39(12): 1380-1389, 2019 11 13.
Article in English | MEDLINE | ID: mdl-30239596

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.


Subject(s)
Cosmetic Techniques/psychology , Esthetics/psychology , Social Perception , Adolescent , Adult , Aged , Face , Female , Humans , Male , Middle Aged , Patient Reported Outcome Measures , Young Adult
14.
J Drugs Dermatol ; 17(6): 647-655, 2018 06 01.
Article in English | MEDLINE | ID: mdl-29879252

ABSTRACT

A complete approach to facial rejuvenation includes restoration of the skin's surface, relaxation of muscles that contribute to hyperkinetic movement, revolumization, and repositioning/recontouring of descended tissues and fat pads. After receiving 510(k) clearance from the US Food and Drug Administration (FDA) in 2015, the Silhouette InstaLift™ absorbable suspension suture became the only available non-surgical technique for repositioning of facial tissue. In January 2017, a consensus paper presented a review of the literature on the efficacy and safety of absorbable suspension sutures and provided information on treatment procedures. Since that time, the clinical experience of the authors has further shaped their treatment practices, highlighting the need for additional guidelines to support an optimal treatment approach. This update will expand upon the 2017 consensus paper on the safety and efficacy of absorbable suspension sutures and provide guidance for obtaining consistently high patient satisfaction with the procedure. Recommendations are based on the extensive clinical experience of expert physicians with absorbable suspension sutures over the past 2.5 years. Here, the authors provide guidance on full face assessment and treatment to support maximum benefit and provide patient selection and procedural recommendations. In addition, the authors stress the benefits of the dual mechanisms of action within the absorbable suspension suture: the immediate lift and volumizing over time that together lead to the outcome of recontouring. J Drugs Dermatol. 2018;17(6):647-655.


Subject(s)
Consensus , Expert Testimony/standards , Rejuvenation , Rhytidoplasty/standards , Skin Aging/pathology , Suture Techniques/standards , Expert Testimony/methods , Humans , Patient Satisfaction , Postoperative Care/methods , Postoperative Care/standards , Rhytidoplasty/methods , Surgery, Plastic/methods , Surgery, Plastic/standards , Sutures/standards , Treatment Outcome
15.
Aesthet Surg J ; 38(5): 540-556, 2018 Apr 06.
Article in English | MEDLINE | ID: mdl-29244069

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.


Subject(s)
Bimatoprost/administration & dosage , Botulinum Toxins, Type A/administration & dosage , Cosmetic Techniques , Dermal Fillers/administration & dosage , Rejuvenation , Adult , Combined Modality Therapy/methods , Esthetics , Face , Female , Humans , Injections, Intramuscular , Injections, Subcutaneous , Male , Middle Aged , Patient Satisfaction , Prospective Studies , Self Concept , Skin Aging , Treatment Outcome
16.
J Drugs Dermatol ; 16(6): s84-s86, 2017 Jun 01.
Article in English | MEDLINE | ID: mdl-29028858

ABSTRACT

Aging gracefully has taken on a whole new meaning over the past few decades as new aesthetic treatments have been developed and are becoming more sophisticated by the day. The aging process, which is exacerbated by chronic UV exposure, results in dyspigmentation, loss of skin laxity, precancerous and cancerous skin lesions, fat loss and redistribution, and bone resorption. Laser and light devices can be used to treat dyspigmentation, while neuromodulators and soft tissue fillers can be used for rhytides and revolumization. Newer procedures include using resorbable polyglycolide/L-lactide suspension sutures with bidirectional cones for mid face revolumization, deoxycholic acid injections for submental fat reduction, and radiofrequency energy. Certain over-the-counter products can increase the risk of postprocedure bruising, while arnica and bromelain may help decrease this risk. Dermatologists continue to be at the forefront of aesthetic treatments, ready and willing to help the aging population look and feel their best.

J Drugs Dermatol. 2017;16(6 Suppl):s84-86.

.


Subject(s)
Cosmetic Techniques , Skin Aging , Aged , Health Services for the Aged , Humans
17.
J Drugs Dermatol ; 16(3): 260-264, 2017 Mar 01.
Article in English | MEDLINE | ID: mdl-28301622

ABSTRACT

Dermatologists treat actinic keratosis (AK) primarily because these lesions have the potential to progress to invasive squamous cell carcinoma. Patients, on the other hand, generally seek treatment to remove the lesions and achieve an improved appearance of their skin following treatment. In selecting a treatment option for AK, dermatologists should consider post-treatment cosmesis, because cosmetic outcomes differ across AK treatments. To obtain expert opinion on the cosmetic sequelae related to chronically photodamaged skin and the treatment of AK, an expert panel meeting among dermatologists was conducted in February 2016. These experts reviewed current treatment options for photodamage, including AK, and discussed the relative merits of the various cosmetic assessments commonly used by investigators and patients in both clinical trial and dermatology practice settings. A main goal of the expert panel meeting was to propose assessment tools that could be specifically designed to characterize cosmesis results after treatment of AK. The panel agreed that existing tools for measurement of cosmetic outcomes following treatment of photodamage could also be used to evaluate cosmesis after treatment of AK. Digital photography is probably the best method used for this, with validation by other technologies. Better measurement tools specifically for assessing cosmesis after AK treatment are needed. Once they are developed and validated, regulatory agencies should be educated about the importance of including cosmetic outcomes as a component of product labeling.

J Drugs Dermatol. 2017;16(3):260-265.

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Subject(s)
Consensus , Dermatologists/psychology , Esthetics , Keratosis, Actinic/drug therapy , Photochemotherapy/methods , Skin Aging/radiation effects , Sunlight/adverse effects , Carcinoma, Squamous Cell/etiology , Humans , Keratosis, Actinic/complications , Keratosis, Actinic/etiology , Patient Reported Outcome Measures , Photography , Practice Guidelines as Topic , Skin Aging/drug effects , Skin Neoplasms/etiology , Sunscreening Agents/therapeutic use , Treatment Outcome
18.
J Drugs Dermatol ; 16(7): 661-666, 2017 Jul 01.
Article in English | MEDLINE | ID: mdl-28697217

ABSTRACT

BACKGROUND: Signs of facial aging include wrinkles, loss of subcutaneous volume, decreased tone, texture, and sagging of the skin. The objective of this review is to determine whether facial suspension absorbable sutures are a safe and effective modality for facial rejuvenation.

METHOD: A group of US plastic surgeons and dermatologists who practice medical aesthetics convened to review evidence obtained from literature searches and to reach a consensus on clinical practice guidelines for the use of facial absorbable suspension sutures.

RESULTS: Currently, there are different types of lifting sutures available. Absorbable, facial suspension sutures allow for superior repositioning of tissue along a vector line together with the added benefit of volumization of the area. These benefits are for patients who have moderate facial aging and require treatment beyond the use of injectable products only.

CONCLUSIONS: Treatment with absorbable facial suspension sutures, when performed properly, is associated with minor and infrequent complications and offers a beneficial clinical alternative to traditional facial rejuvenation techniques.

J Drugs Dermatol. 2017;16(7):661-666.

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Subject(s)
Consensus , Cosmetic Techniques/trends , Rejuvenation/physiology , Rhytidoplasty/trends , Skin Aging/physiology , Absorbable Implants/standards , Absorbable Implants/trends , Cosmetic Techniques/standards , Dermatologists/standards , Dermatologists/trends , Humans , Rhytidoplasty/methods , Rhytidoplasty/standards , Surgery, Plastic/methods , Surgery, Plastic/standards , Surgery, Plastic/trends
19.
Dermatol Surg ; 42 Suppl 2: S177-91, 2016 May.
Article in English | MEDLINE | ID: mdl-27128246

ABSTRACT

BACKGROUND: The HARMONY study is the first clinical trial to assess the impact of a global approach to facial rejuvenation with several minimally invasive modalities, using patient-reported outcome measures. OBJECTIVE: Provide details of this treatment approach and describe investigators' experiences and recommendations based on this study. METHODS: This multicenter, 4-month study evaluated subject satisfaction with and psychological impact of combined treatment with VYC-20L (Juvéderm Voluma XC), HYC-24L (Juvéderm Ultra XC), HYC-24L+ (Juvéderm Ultra Plus XC), onabotulinumtoxinA (Botox), and bimatoprost 0.3% ophthalmic solution (Latisse). Treatment-naive adults with moderate-to-severe facial lines and folds and eyelash hypotrichosis received on-label, staged treatment with fillers. Bimatoprost was self-administered once daily for 17 weeks from day 1. OnabotulinumtoxinA was administered for glabellar lines, crow's feet lines, or both at month 3. RESULTS: Overall, 100 subjects received bimatoprost for eyelash hypotrichosis, 96 received onabotulinumtoxinA for glabellar lines and/or crow's feet lines, and 96 received VYC-20L for midface volume deficit. From 17 to 96 subjects received HYC-24L and/or HYC-24L+ for nasolabial folds, oral commissures, marionette lines, perioral lines, or radial cheek lines. Injections of filler generally progressed from cranial to caudal, with midface injected first. Investigator-reported factors that may have contributed to the potential benefits of this approach include the critical role of the midface in facial aesthetics, use of lower volumes of filler in individual facial areas, and anesthetic effects. CONCLUSION: The investigators' perspectives and experience with the injection pattern, sequencing, volumes, and techniques may provide valuable guidance for a multimodal approach to facial aesthetic treatment.


Subject(s)
Antihypertensive Agents/therapeutic use , Bimatoprost/therapeutic use , Botulinum Toxins, Type A/administration & dosage , Cosmetic Techniques , Dermal Fillers/administration & dosage , Neuromuscular Agents/administration & dosage , Skin Aging , Adult , Aged , Cosmetic Techniques/psychology , Drug Therapy, Combination , Eyelashes , Face , Female , Humans , Hyaluronic Acid/administration & dosage , Hypotrichosis/drug therapy , Male , Middle Aged , Prospective Studies , Single-Blind Method
20.
Dermatol Surg ; 42(10): 1164-73, 2016 Oct.
Article in English | MEDLINE | ID: mdl-27661429

ABSTRACT

BACKGROUND: The American Council of Graduate Medical Education, which oversees much of postgraduate medical education in the United States, has championed the concept of "milestones," standard levels of achievement keyed to particular time points, to assess trainee performance during residency. OBJECTIVE: To develop a milestones document for the American Society for Dermatologic Surgery (ASDS) Cosmetic Dermatologic Surgery (CDS) fellowship program. METHODS: An ad hoc milestone drafting committee was convened that included members of the ASDS Accreditation Work Group and program directors of ASDS-approved Cosmetic Dermatologic Surgery (CDC) fellowship training programs. Draft milestones were circulated through email in multiple rounds until consensus was achieved. RESULTS: Thirteen milestones were developed in the 6 Accreditation Council for Graduate Medical Education (ACGME) competency areas, with 8 of these being patient-care milestones. Additional instructions for milestone administration more specific to the CDS fellowship than general ACGME instructions were also approved. Implementation of semiannual milestones was scheduled for the fellowship class entering in July 2018. CONCLUSION: Milestones are now available for CDS fellowship directors to implement in combination with other tools for fellow evaluation.


Subject(s)
Cosmetic Techniques , Dermatologic Surgical Procedures/education , Education, Medical, Graduate , Fellowships and Scholarships , Organizational Objectives , Accreditation , Humans , Societies, Medical , United States
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