RESUMO
BACKGROUND: Hyaluronic acid injections are increasingly administered for correction of infraorbital hollows (IOHs). OBJECTIVES: The objective of this study was to examine the effectiveness (IOH correction) and safety of Restylane Eyelight hyaluronic acid (HAEYE) injections. METHODS: Patients with moderate/severe IOHs, assessed with the Galderma infraorbital hollows scale (GIHS), were randomized to HAEYE injections (by needle/cannula) (Day 1 + optional Month 1 touch-up) or no-treatment control. The primary endpoint was blinded evaluator-reported Month 3 response, defined as ≥1-point GIHS improvement from baseline (both sides, concurrently). Other endpoints examined investigator-reported aesthetic improvement on the Global Aesthetic Improvement Scale (GAIS), patient-reported satisfaction (FACE-Q satisfaction with outcome; satisfaction questionnaire), and adverse events. RESULTS: Overall, 333 patients were randomized. Month 3 GIHS responder rate was significantly higher for HA-EYE (87.4%) vs control (17.7%; P < .001), and comparable between HA-EYE-needle and HA-EYE-cannula groups (P = .967). HAEYE GAIS responder rate was 87.5-97.7% (Months 3-12). Mean FACE-Q Rasch-transformed scores were 64.3-73.5 (HAEYE) vs 14.1-16.2 (control) through Month 12. Patients reported looking younger (≥71%) and less tired (≥79%) with reduced undereye shadows (≥76%) and recovered within 3-5 hours posttreatment. Efficacy was maintained through Month 12 (63.5% GIHS responders) and through Month 18, after Month 12 retreatment (80.3% GIHS responders; 99.4% GAIS responders; FACE-Q scores 72.5-72.8). Forty patients (12.7%) reported typically mild adverse events (4.9% HAEYE-needle; 20.9% HAEYE-cannula). CONCLUSIONS: HAEYE treatment was effective in correcting moderate/severe IOHs at the primary endpoint (Month 3). Efficacy was sustained through Month 12 after first treatment for 63.5% and through Month 18 for 80.3% (after 1 retreatment) with needle or cannula administration. Safety outcomes were reassuring.
Assuntos
Técnicas Cosméticas , Preenchedores Dérmicos , Ácido Hialurônico , Satisfação do Paciente , Humanos , Ácido Hialurônico/administração & dosagem , Ácido Hialurônico/efeitos adversos , Ácido Hialurônico/análogos & derivados , Feminino , Masculino , Pessoa de Meia-Idade , Adulto , Resultado do Tratamento , Preenchedores Dérmicos/administração & dosagem , Preenchedores Dérmicos/efeitos adversos , Técnicas Cosméticas/efeitos adversos , Idoso , Estética , Adulto Jovem , Método Simples-CegoRESUMO
BACKGROUND: Extending the duration of effect of botulinum toxins-by administering doses beyond those of the approved labels-has been an area of increasing interest in the field of aesthetics. OBJECTIVES: The aim of this study was to investigate the safety and duration of effect of 40-unit (U) prabotulinumtoxinA-xvfs (twice the approved dose and concentration) for the treatment of moderate-to-severe glabellar lines. METHODS: A total of 154 adult patients were randomized 1:1:1 to a single treatment of either 40â U prabotulinumtoxinA-xvfs (PRA 40, 5 injections of 8â U/0.05â mL), or 20â U of either prabotulinumtoxinA-xvfs (PRA 20) or onabotulinumtoxinA (ONA 20). Both 20-U controls were administered as 5 injections of 4â U/0.1â mL. Efficacy and safety were assessed on days 2, 7 (by telephone), 30, and every 30 days thereafter up to 365 days or until the patient had returned to baseline. The primary effectiveness endpoint was the duration of effect (estimated by Kaplan-Meier analysis), defined as the number of days from treatment day (baseline) to the day that glabellar line severity at maximum frown by investigator assessment returned to the baseline value. RESULTS: Patients had a mean age of 47 years (20-72 years); 69.5% had severe glabellar lines at baseline. Of the 36 adverse events, 32 (88.9%) were mild and 4 (11.1%) were moderate in severity; none were serious. The median durations of effect were estimated to be 183, 149, and 148 days for PRA 40-, PRA 20-, and ONA 20-treated patients, respectively. CONCLUSIONS: In this phase 2 pilot study, 40â U prabotulinumtoxinA-xvfs was observed to be safe and had a duration of 6 months.
Assuntos
Toxinas Botulínicas Tipo A , Testa , Envelhecimento da Pele , Humanos , Toxinas Botulínicas Tipo A/administração & dosagem , Toxinas Botulínicas Tipo A/efeitos adversos , Feminino , Masculino , Método Duplo-Cego , Adulto , Pessoa de Meia-Idade , Envelhecimento da Pele/efeitos dos fármacos , Resultado do Tratamento , Fatores de Tempo , Fármacos Neuromusculares/administração & dosagem , Fármacos Neuromusculares/efeitos adversos , Idoso , Técnicas Cosméticas/efeitos adversos , Adulto JovemRESUMO
BACKGROUND: Maximizing patient comfort during hyaluronic acid gel injection is a common concern that is usually addressed by selecting fillers with lidocaine. OBJECTIVE: Two randomized, double-blinded, split-face trials aimed to demonstrate noninferiority of specific hyaluronic acid fillers incorporating mepivacaine (RHA-M) versus their lidocaine controls, at providing pain relief. METHODS: Thirty subjects per trial received injections of RHA R -M versus RHA R , and RHA4-M versus RHA4, respectively, in the perioral rhytids (PR) and nasolabial folds (NLF). Pain was assessed on a visual analog scale; aesthetic effectiveness was evaluated with validated scales, and safety was monitored based on common treatment responses (CTRs) and adverse events (AEs). RESULTS: RHA-M fillers proved as effective as their lidocaine counterparts at reducing pain (noninferior, p < .0002 and p < .0001). Bilateral wrinkle improvement was measured both in the PR (-1.5 ± 0.6 points on each side) and in the NLF (-1.8 ± 0.6 and -1.9 ± 0.5 points) trials at one month, with virtually identical responder rates (≥96.7%). Common treatment responses and AEs were similar between treated sides, and none was clinically significant. CONCLUSION: Resilient hyaluronic acid fillers with either mepivacaine or lidocaine are equally effective at reducing pain during treatment and equally performant and safe for correction of dynamic facial wrinkles and folds.
Assuntos
Técnicas Cosméticas , Preenchedores Dérmicos , Ácido Hialurônico , Anestésicos Locais , Técnicas Cosméticas/efeitos adversos , Preenchedores Dérmicos/efeitos adversos , Método Duplo-Cego , Humanos , Ácido Hialurônico/efeitos adversos , Lidocaína , Mepivacaína/efeitos adversos , Sulco Nasogeniano , Dor/prevenção & controle , Conforto do Paciente , Envelhecimento da Pele , Resultado do TratamentoRESUMO
Background: Collagen-rich fibrous septae and subcutaneous adipose protrusions play a role in cellulite pathophysiology. Collagenase clostridium histolyticum-aaes (CCH-aaes) injection causes enzymatic release of septae to resolve cellulite depressions and create a skin smoothing effect. This analysis pooled data from two identically designed, phase-3, randomized, double-blind, placebo-controlled studies to examine the efficacy and safety of CCH-aaes. Methods: Adult women with moderate/severe cellulite (3-4 on Clinician Reported Photonumeric Cellulite Severity Scale and Patient Reported Photonumeric Cellulite Severity Scale) on the buttocks received up to three treatment sessions (Days 1, 22, and 43) of subcutaneous CCH-aaes 0.84 mg or placebo per treatment area. Composite and individual component response (≥2-level or ≥1-level improvement from baseline in Patient Reported Photonumeric Cellulite Severity Scale and/or Clinician Reported Photonumeric Cellulite Severity Scale) and additional patient-reported outcomes were determined at Day 71. Results: Analysis included 424 CCH-aaes-treated and 419 placebo-treated women. CCH-aaes-treated women were 5.9 times more likely than placebo-treated women to be ≥2-level composite responders at Day 71 (odds ratio [95% confidence interval], 5.9 [2.2-15.4]; P < 0.001). A significantly greater percentage of CCH-aaes-treated women versus placebo-treated women were ≥1-level composite responders at Day 71 (39.4% versus 14.6%; P < 0.001). Subgroup analyses indicated no apparent impact of Fitzpatrick skin type category and baseline cellulite severity (moderate/severe) on CCH-aaes efficacy. An inverse relationship between age and CCH-aaes response was observed in those with a body mass index less than 32 kg per m2. The most common adverse events with CCH-aaes were injection-site bruising and injection-site pain. Conclusion: CCH-aaes treatment significantly improved moderate-to-severe buttock cellulite appearance and was generally well tolerated.
RESUMO
BACKGROUND: OnabotulinumtoxinA 20 U reduces glabellar line (GL) severity at maximum frown for approximately 3 to 4 months. Small studies have suggested that >20-U doses may increase the efficacy and duration of response for GLs. OBJECTIVES: The aim of this study was to evaluate safety, pharmacodynamic response, and treatment satisfaction with onabotulinumtoxinA doses ≥20 U for GLs. METHODS: This 48-week, double-blind study compared 40, 60, and 80 U onabotulinumtoxinA vs 20 U and placebo in women with moderate or severe dynamic GLs on the Allergan Facial Wrinkle Scale. The following parameters were evaluated: the percentage of subjects with investigator-assessed ≥1-grade Facial Wrinkle Scale improvement from baseline at maximum frown (responders) at Week 24; the estimated median duration of response; the proportion of mostly/very satisfied responders on the Facial Line Satisfaction Questionnaire follow-up Items 1 to 5; and treatment-emergent adverse events. RESULTS: The modified intent-to-treat population (Nâ =â 226) had a mean age of 48.0 years, with similar baseline GL severity between treatment groups. Week 24 responder rates were 0% for placebo and 16.0%, 32.0%, 30.6%, and 38.5% for onabotulinumtoxinA 20, 40, 60, and 80 U, with significant (Pâ <â 0.05) differences for 40 and 80 U vs 20 U. Median duration of response was longer with all higher doses vs 20 U (≥24.0 vs 19.7 weeks; Pâ <â 0.05 vs 20 U at Week 24). Facial Line Satisfaction Questionnaire results indicated high subject satisfaction. The incidence and severity of treatment-emergent adverse events did not exhibit a dose-response effect. CONCLUSIONS: GL treatment with onabotulinumtoxinA doses >20 U demonstrated longer duration of response and higher patient-reported satisfaction vs the on-label 20-U dose with no apparent impact on safety variables.
Assuntos
Toxinas Botulínicas Tipo A , Fármacos Neuromusculares , Envelhecimento da Pele , Método Duplo-Cego , Feminino , Testa , Humanos , Pessoa de Meia-Idade , Satisfação do Paciente , Satisfação Pessoal , Resultado do TratamentoRESUMO
BACKGROUND: The perioral region is highly mobile and subject to multifactorial changes during aging. Resilient Hyaluronic Acid Redensity (RHAR), an RHA filler, was developed with the aim of optimizing outcomes in dynamic facial areas. OBJECTIVE: This randomized, blinded, multicenter clinical study aimed to demonstrate superiority of RHAR over no-treatment control for correction of moderate-to-severe dynamic perioral rhytides. MATERIALS AND METHODS: Blinded live evaluator assessments of efficacy included improvement in perioral rhytides severity using a proprietary scale (Perioral Rhytids Severity Rating Scale [PR-SRS]) and the Global Aesthetic Improvement Scale. Subjects self-assessed their results with FACE-Q, a validated patient-reported outcome measure, and satisfaction scales. Safety was monitored throughout the study based on common treatment responses (CTRs) and adverse events (AEs). RESULTS: The primary efficacy end point was achieved, with the treatment group showing statistically significant superiority over the control group at Week 8 (80.7% vs 7.8% responder rate by PR-SRS, p < .0001). Most patients (66%) were still responders at Week 52 (study completion). Most AEs were CTRs after perioral injection of a dermal filler, and none was a clinically significant treatment-related AE. CONCLUSION: Resilient Hyaluronic Acid Redensity is effective and safe for the correction of dynamic perioral rhytides in all Fitzpatrick phototypes, with marked durability.
Assuntos
Preenchedores Dérmicos/administração & dosagem , Ácido Hialurônico/administração & dosagem , Ritidoplastia/métodos , Envelhecimento da Pele/efeitos dos fármacos , Idoso , Preenchedores Dérmicos/efeitos adversos , Feminino , Humanos , Ácido Hialurônico/efeitos adversos , Ácido Hialurônico/análogos & derivados , Masculino , Pessoa de Meia-Idade , Medidas de Resultados Relatados pelo Paciente , Satisfação do Paciente , Estudos ProspectivosRESUMO
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 independently assessed by both investigator and patient on the validated 4-point photonumeric Glabellar Line Scale (0â =â no lines, 1â =â mild, 2â =â moderate, 3â =â severe), were enrolled. On day 0, patients received an initial treatment (IT) of 20 U prabotulinumtoxinA (4 U/0.1 mL final vacuum-dried formulation injected into 5 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 outcomes were evaluated throughout the study. RESULTS: The 570 study patients received a median total dose of 60 U, that is, 3 treatments. Sixty-one patients (10.7%) experienced adverse events (AEs) assessed as possibly study drug related; 6.5% experienced study drug-related AEs after the IT. With each RT, progressively lower percentages of patients experienced study drug-related AEs. Eight patients (1.4%) experienced study drug-related AEs of special interest: 5 experienced eyelid ptosis (0.9%), 3 eyebrow ptosis (0.5%), 1 blepharospasm (0.2%), and 1 blurred vision (0.2%). Seven patients (1.2%) experienced serious AEs, but none were study drug related. A total of 4060 serum samples were tested for antibotulinum toxin antibodies; no seroconversion was observed. CONCLUSIONS: The safety of RTs of 20 U of prabotulinumtoxinA for moderate to severe glabellar lines was confirmed in this second phase II study based on a broad range of outcomes.
Assuntos
Blefaroptose , Toxinas Botulínicas Tipo A , Fármacos Neuromusculares , Envelhecimento da Pele , Adulto , Toxinas Botulínicas Tipo A/efeitos adversos , Método Duplo-Cego , Testa , Humanos , Resultado do TratamentoRESUMO
BACKGROUND: Fibrous septae play a role in contour alterations associated with cellulite. OBJECTIVE: To assess collagenase clostridium histolyticum-aaes (CCH) for the treatment of cellulite. MATERIALS AND METHODS: Two identically designed phase 3, double-blind, randomized studies (RELEASE-1 and RELEASE-2) were conducted. Adult women with moderate/severe cellulite (rating 3-4 on the Patient Reported Photonumeric Cellulite Severity Scale [PR-PCSS] and Clinician Reported PCSS [CR-PCSS]) on the buttocks received up to 3 treatment sessions of subcutaneous CCH 0.84 mg or placebo per treatment area. Composite response (≥2-level or ≥1-level improvement from baseline in both PR-PCSS and CR-PCSS) was determined at Day 71. RESULTS: Eight hundred forty-three women received ≥1 injection (CCH vs placebo: RELEASE-1, n = 210 vs n = 213; RELEASE-2, n = 214 vs n = 206). Greater percentages of CCH-treated women were ≥2-level composite responders versus placebo in RELEASE-1 (7.6% vs 1.9%; p = .006) and RELEASE-2 (5.6% vs 0.5%; p = .002) and ≥1-level composite responders in RELEASE-1 (37.1% vs 17.8%; p < .001) and RELEASE-2 (41.6% vs 11.2%; p < .001). Most adverse events (AEs) in the CCH group were injection site related; few CCH-treated women discontinued because of an AE (≤4.3%). CONCLUSION: Collagenase clostridium histolyticum-aaes significantly improved cellulite appearance and was generally well tolerated.
Assuntos
Celulite/tratamento farmacológico , Colagenase Microbiana/uso terapêutico , Anticorpos Neutralizantes/sangue , Método Duplo-Cego , Feminino , Humanos , Reação no Local da Injeção/etiologia , Colagenase Microbiana/efeitos adversos , Colagenase Microbiana/imunologia , Pessoa de Meia-Idade , Satisfação do Paciente , Resultado do TratamentoRESUMO
BACKGROUND: Limited US clinical data are available on the use of aesthetic products in patients with skin of color (SOC). OBJECTIVE: To compare the efficacy and safety of prabotulinumtoxinA for the treatment of glabellar lines in patients with and without SOC. METHODS AND MATERIALS: Post hoc analyses were performed on the pooled population of all 492 patients treated with 20U prabotulinumtoxinA in the 2 US single-dose Phase III glabellar line clinical studies. Patients were grouped by Fitzpatrick skin Type: IV + V + VI (with SOC) versus I + II + III (without SOC). The primary efficacy end point was the proportion of responders with a ≥1-point improvement from baseline at maximum frown on the 4-point Glabellar Line Scale. Adverse events (AEs) were also summarized. RESULTS: Responder rates among patients with SOC (n = 140) were lower than those without SOC (n = 352), by 5.9% on average across all visits; at no time point were differences statistically significant. At Day 30, responder rates were 94.0% and 96.0%, respectively (p = .401). Headache was the most common treatment-related AE, occurring in 12.1% and 8.2% of patients with and without SOC, respectively. CONCLUSION: A single dose of 20U prabotulinumtoxinA was well tolerated and similar in effectiveness in patients with and without SOC for the treatment of glabellar lines.
Assuntos
Toxinas Botulínicas Tipo A/administração & dosagem , Testa , Fármacos Neuromusculares/administração & dosagem , Envelhecimento da Pele/efeitos dos fármacos , Pigmentação da Pele , Adulto , Toxinas Botulínicas Tipo A/efeitos adversos , Feminino , Humanos , Injeções , Masculino , Pessoa de Meia-Idade , Fármacos Neuromusculares/efeitos adversos , Estados UnidosRESUMO
BACKGROUND: A range of monophasic dermal fillers made of high-molecular-weight hyaluronic acid (HA) chains with reduced cross-linking was developed for aesthetic procedures. OBJECTIVE: The efficacy, durability, and safety of 2 of these resilient HA (RHA) fillers, and their noninferiority to an effective HA comparator available in the United States, were tested in the treatment of dynamic facial wrinkles. METHODS: A 15-month, prospective, multicenter, active-controlled, randomized, double-blinded, split-face clinical trial was carried out on 174 subjects presenting moderate-to-severe bilateral nasolabial folds (NLFs). Assessed parameters included improvement on a proprietary Wrinkle Severity Rating Scale (WSRS) and Global Aesthetic Improvement Scale, according to Blind Live Evaluators, subjects, and treating investigators. Self-perception was evaluated with FACE-Q and satisfaction scales. RESULTS: The per-protocol populations included 67 and 62 subjects of all Fitzpatrick skin-phototypes, in the 2 comparison groups. Significant improvement of mean WSRS scores and associated responder rates established the noninferiority of RHA fillers to their comparator, over 15 months. Aesthetic improvement and subject satisfaction were durably high, with no meaningful differences between the fillers. Treatments were safe and well tolerated. CONCLUSION: The 2 RHA fillers are at least equivalent to a well-established comparator for the correction of NLF in subjects of diverse skin-phototypes.
Assuntos
Técnicas Cosméticas/efeitos adversos , Preenchedores Dérmicos/administração & dosagem , Ácido Hialurônico/análogos & derivados , Envelhecimento da Pele/efeitos dos fármacos , Adulto , Idoso , Preenchedores Dérmicos/efeitos adversos , Método Duplo-Cego , Estética , Feminino , Humanos , Ácido Hialurônico/administração & dosagem , Ácido Hialurônico/efeitos adversos , Masculino , Pessoa de Meia-Idade , Sulco Nasogeniano , Estudos Prospectivos , Resultado do Tratamento , Estados UnidosRESUMO
BACKGROUND: DaxibotulinumtoxinA for Injection (DAXI) is a novel botulinum toxin type A formulation in clinical development. A phase 2 dose-ranging study identified an optimal dose and demonstrated efficacy with a median duration of 24 weeks. METHODS: In two phase 3, multicenter, randomized, double-blind, placebo-controlled studies (SAKURA 1 and SAKURA 2), subjects with moderate or severe glabellar lines at maximum frown were assigned randomly to receive placebo or 40 U of DAXI. Glabellar lines were evaluated at least every 4 weeks for at least 24 weeks until severity returned to baseline (≤36 weeks). RESULTS: Overall, 609 subjects were enrolled (DAXI, n = 405; placebo, n = 204). DAXI was significantly more effective than placebo in achieving the primary efficacy outcome (≥2-point improvement in glabellar line severity at maximum frown at week 4 according to both investigator and subject ratings): 73.6 percent versus 0.0 percent (SAKURA 1), and 74.0 percent versus 1.0 percent (SAKURA 2) (both p < 0.0001). Composite investigator and subject ratings of maximum frown after DAXI treatment showed that glabellar line severity of none or mild was maintained for a median of 24.0 weeks (SAKURA 1) and 23.9 weeks (SAKURA 2), and glabellar line severity did not return to baseline levels for a median of 27.7 and 26.0 weeks, respectively. DAXI was generally well tolerated, with the most common adverse events related to DAXI treatment being headache (SAKURA 1, 7.0 percent; SAKURA 2, 5.9 percent) and injection-site pain (5.0 percent and 2.4 percent, respectively). CONCLUSIONS: Results from both studies were highly consistent. DAXI may offer a prolonged duration of response (median, ≥24 weeks) and is generally well tolerated. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, I.
Assuntos
Toxinas Botulínicas Tipo A/farmacologia , Injeções , Fármacos Neuromusculares/farmacologia , Envelhecimento da Pele/efeitos dos fármacos , Adulto , Toxinas Botulínicas Tipo A/administração & dosagem , Método Duplo-Cego , Feminino , Testa , Humanos , Masculino , Pessoa de Meia-Idade , Fármacos Neuromusculares/administração & dosagem , Adulto JovemRESUMO
BACKGROUND/OBJECTIVES: This trial evaluated the effectiveness and safety of Bellafill for full-face acne scar treatment. PATIENTS AND METHODS: In this open-label, nonrandomized, multicenter pilot study investigating the use of polymethylmethacrylate for full-face atrophic acne scar correction, 42 adult subjects with a mean age of 43 years were treated and assessed for safety and effectiveness at Months 4 and 7. There were no hypersensitivity reactions to pretreatment skin testing or during scar treatments. RESULTS: At 4 and 7 months after initial treatment, 92% and 95% of subjects, respectively, were responders with ≥1-point improvement on the 5-point Acne Scar Assessment Scale. Subjects reported very high levels of improvement on the Global Aesthetic Improvement Scale (GAIS), with 95% of subjects reporting "improved or better" at 4 months and 90% at 7 months. The outcome of the physician GAIS was also high with 92% of patients classified as "improved or better" at 4 months and 97% at 7 months. There were only 2 device-related adverse events, both mild events related to Bellafill skin test (bruising, ecchymosis). There were no serious adverse events in response to the treatment product in this short-term follow-up study. CONCLUSION: Polymethylmethacrylate is effective for treating full-face acne scarring. Clinicaltrials.gov #NCT02642627.
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Acne Vulgar/complicações , Cicatriz/terapia , Colágeno/administração & dosagem , Preenchedores Dérmicos/administração & dosagem , Polimetil Metacrilato/administração & dosagem , Adulto , Atrofia/diagnóstico , Atrofia/etiologia , Atrofia/terapia , Cicatriz/diagnóstico , Cicatriz/etiologia , Colágeno/efeitos adversos , Preenchedores Dérmicos/efeitos adversos , Equimose/diagnóstico , Equimose/etiologia , Face , Feminino , Seguimentos , Humanos , Injeções Intralesionais , Masculino , Polimetil Metacrilato/efeitos adversos , Estudo de Prova de Conceito , Índice de Gravidade de Doença , Testes Cutâneos/efeitos adversos , Resultado do Tratamento , Adulto JovemRESUMO
BACKGROUND: ATX-101, an injectable form of deoxycholic acid, is approved in the United States and Canada for submental fat (SMF) reduction. OBJECTIVE: To report results of REFINE-1, a randomized, double-blind, placebo-controlled, Phase 3 trial investigating the efficacy and safety of ATX-101. METHODS: Subjects dissatisfied with their moderate or severe SMF received ATX-101 (2 mg/cm) or placebo. Coprimary outcome measures were composite ≥1-grade and ≥2-grade improvements in clinician-assessed and subject-assessed SMF severity using validated scales at 12 weeks after last treatment. Magnetic resonance imaging (MRI) provided an objective measure of submental volume reduction. Patient-reported outcomes were assessed. RESULTS: Among 256 ATX-101-treated and 250 placebo-treated subjects, a ≥1-grade composite response was achieved in 70.0% and 18.6%, and a ≥2-grade composite response in 13.4% and 0%, respectively (p < .001 for both). The proportion of MRI responders was more than 8 times higher with ATX-101 than placebo (46.3% vs 5.3%; p < .001). ATX-101-treated subjects reported improvement in the psychological impact of SMF and satisfaction with treatment (p < .001 for all assessments vs placebo). Of note, 55% and 75% of ATX-101-treated subjects reported 1-grade improvement in clinician-assessed SMF after 2 and 4 treatments, respectively. Adverse events (primarily localized to the injection site) were mostly mild or moderate, and transient. Marginal mandibular nerve paresis reported in 4.3% of ATX-101-treated subjects (1.0% of all ATX-101 treatment sessions) was mostly mild, transient, and resolved without sequelae. CONCLUSION: ATX-101 is a safe and efficacious, first-in-class, injectable drug for SMF reduction.
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Técnicas Cosméticas , Ácido Desoxicólico/administração & dosagem , Gordura Subcutânea/efeitos dos fármacos , Adolescente , Adulto , Idoso , Queixo/anatomia & histologia , Ácido Desoxicólico/efeitos adversos , Método Duplo-Cego , Feminino , Humanos , Injeções Subcutâneas , Imageamento por Ressonância Magnética , Masculino , Pessoa de Meia-Idade , Satisfação do Paciente , Resultado do Tratamento , Adulto JovemRESUMO
OBJECTIVE: To evaluate the duration of effect of a single dose of 120 units of abobotulinumtoxinA for the treatment of moderate to severe glabellar lines. DESIGN: Investigator-initiated, prospective, multi-center, open-label study. MATERIAL AND METHODS: This open-label trial of thirty subjects with moderate to severe glabellar lines at maximum frown was per- formed at 2 private plastic surgery clinics. 120 units of abobotulinumtoxinA was injected in 5 equal aliquots (24 units each) into each of 5 injection sites in the glabellar complex. Investigator and subject assessments of wrinkle severity at maximum frown and repose using 4-point scales and adverse events were conducted. Follow-up was monthly for up to 11 months. RESULTS: The median duration of response for all subjects, as assessed by the investigator, was 150 days (95% CI: 120, 180). The median duration of response was 165 days (95% CI: 90, 180) for subjects with Grade 2 (Moderate) wrinkles at baseline and 75 days (95% CI: 30, 120) for subjects with Grade 3 (Severe) wrinkles at baseline. Overall, 76.7% of subjects had a duration of ≥ 120 days. At the end of study (day 300) 9/16 (53%) of subjects who were Grade 3 at baseline still rated themselves as not returning to Grade 3, demonstrating ongoing improvement. Adverse events were mild and transient. There were no events of lid or brow ptosis. CONCLUSIONS: The 120 units of abobotulinumtoxinA were significantly effective in reducing glabellar lines in subjects with Grade 2 (Moderate) wrinkles at baseline for a longer duration than the reported 85 days in the FDA Phase III randomized, placebo-controlled clinical studies using a standard 50 unit dose. Subject satisfaction was high. There was no increase in the incidence of adverse events with this higher dose. J Drugs Dermatol. 2016;15(12):1544-1549.
Assuntos
Toxinas Botulínicas Tipo A/administração & dosagem , Técnicas Cosméticas , Fármacos Neuromusculares/administração & dosagem , Envelhecimento da Pele/efeitos dos fármacos , Toxinas Botulínicas Tipo A/efeitos adversos , Relação Dose-Resposta a Droga , Feminino , Seguimentos , Testa , Humanos , Masculino , Fármacos Neuromusculares/efeitos adversos , Satisfação do Paciente , Estudos Prospectivos , Índice de Gravidade de Doença , Fatores de Tempo , Resultado do TratamentoRESUMO
With the recent approval of Kythera Biopharmaceuticals (Westlake Village, California) submental fat injectable treatment Kybella, there comes a lot of excitement-but, also a bit of concern. The idea of having a nonsurgical, nonliposuction treatment for people who have a double chin is certainly exciting. The hope has been that this new treatment will provide opportunities for the many people out there who are focused on the appearance of their submental fullness to have access to a safe. affordable, and reliable treatment.With the approval of this product. there are several misconceptions that the authors herein discuss.
Assuntos
Técnicas Cosméticas , Ácido Desoxicólico/farmacologia , Gordura Subcutânea/efeitos dos fármacos , Queixo , HumanosRESUMO
OBJECTIVE: This trial compares the effectiveness and safety of HYC-24L (Juvéderm Ultra XC; Allergan plc, Dublin, Ireland) (24 mg/mL of hyaluronic acid, 0.3% lidocaine) and CPM-22.5 (Belotero Balance; Merz Aesthetics, Raleigh, NC) (22.5 mg/mL of hyaluronic acid) for the treatment of perioral lines. MATERIALS AND METHODS: Men and women aged 35 years or older with moderate-to-severe perioral lines were recruited for this randomized controlled, rater-blinded, 2-arm trial. The primary endpoint was a comparison of rater-assessed responder rates by the validated 4-point Perioral Lines Severity Scale at Month 6; responders were those who showed a ≥1 point improvement. A secondary endpoint was subject-assessed change in perioral lines measured by the Global Assessment of Change Scale. RESULTS: A total of 136 subjects received treatment and 132 completed the trial (mean age: 58 ± 8 years). Total volume injected was 1.18 mL (HYC-24L) and 1.32 mL (CPM-22.5). At Month 6, a significantly greater proportion of HYC-24L subjects responded to treatment (87%) than CPM-22.5 subjects (72%) (p < .04). At all time points, HYC-24L subjects reported significantly greater improvement in their perioral lines than CPM-22.5 subjects, with the greatest difference at Month 6. No unexpected adverse events occurred. CONCLUSION: HYC-24L subjects showed a higher response rate and a greater improvement in their perioral lines than CPM-22.5 subjects for up to 6 months.
Assuntos
Técnicas Cosméticas , Preenchedores Dérmicos/administração & dosagem , Ácido Hialurônico/administração & dosagem , Envelhecimento da Pele/efeitos dos fármacos , Contusões/etiologia , Técnicas Cosméticas/efeitos adversos , Preenchedores Dérmicos/efeitos adversos , Estética , Face , Feminino , Humanos , Ácido Hialurônico/efeitos adversos , Injeções Subcutâneas/efeitos adversos , Masculino , Pessoa de Meia-Idade , Dor/etiologia , Dor/prevenção & controleRESUMO
There are several different classes of synthetic dermal fillers and volume enhancers including semipermanent and permanent products available in the United States. Based on clinical and scientific evidence, this article reviews the chemical and polymeric properties, clinical data, patient selection, indications for use, injection technique, and adverse event profiles of permanent synthetic injectables currently used in clinical practice in the United States: medical-grade liquid injectable silicone and polymethyl methacrylate. Understanding the unique characteristics of these two products reinforces the advantages and disadvantages of each, including under what circumstances they should be used and why they perform the way they do.
Assuntos
Acne Vulgar/tratamento farmacológico , Materiais Biocompatíveis/efeitos adversos , Preenchedores Dérmicos/administração & dosagem , Preenchedores Dérmicos/efeitos adversos , Envelhecimento da Pele/efeitos dos fármacos , Materiais Biocompatíveis/administração & dosagem , Técnicas Cosméticas/efeitos adversos , Durapatita/administração & dosagem , Durapatita/efeitos adversos , Estética , Feminino , Seguimentos , Humanos , Ácido Hialurônico/administração & dosagem , Ácido Hialurônico/efeitos adversos , Injeções Intradérmicas , Injeções Subcutâneas , Ácido Láctico/administração & dosagem , Ácido Láctico/efeitos adversos , Masculino , Rejuvenescimento/fisiologia , Medição de Risco , Silicones/administração & dosagem , Silicones/efeitos adversos , Fatores de Tempo , Resultado do TratamentoRESUMO
As demonstrated by American Society of Plastic Surgeons statistics (2013), patients seeking nonsurgical facial rejuvenation are increasing. A variety of temporary and semipermanent soft-tissue fillers, such as hyaluronic acid, poly-L-lactic acid, and calcium hydroxylapatite, are readily available; however, they have not been proven effective in treating facial acne scarring. Patient tolerance for the inconvenience and repeat cost of short-term, temporary fillers is waning as newer generation fillers with longer durations are coming on the market. Permanent injectable fillers, such a Bellafill (Suneva Medical Inc., San Diego, Calif.), represent a desirable solution for patients who want a long-term result. With the recent Food and Drug Administration approval for the treatment of moderate-to-severe, atrophic, distensible facial acne scars on the cheek(s) in patients over the age of 21 years, Bellafill (polymethylmethacrylate collagen) represents an effective solution for the treatment of facial acne scarring of the face while maintaining an excellent safety profile.