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1.
Facial Plast Surg Clin North Am ; 31(4): 511-519, 2023 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-37806684

RESUMEN

Neurotoxins are the most popular nonsurgical aesthetic procedure for men and women of all ages. Five botulinum toxin A (BoNTA) products represent the current palette of available BoNTA for cosmetic use. Off-label uses of BoNTA continue to expand and are now used for skin rejuvenation, to treat various skin disorders, and in facial nerve paralysis. Dermal and subdermal injections of dilute BoNTA has grown in popularity and been shown to improve skin texture and quality. Common targets for chemodenervation in facial nerve synkinesis are ipsilateral orbicularis oculi, mentalis, depressor anguli oris, buccinator, corrugator muscles, and the ipsilateral and/or contralateral frontalis.


Asunto(s)
Toxinas Botulínicas Tipo A , Envejecimiento de la Piel , Masculino , Humanos , Femenino , Toxinas Botulínicas Tipo A/uso terapéutico , Neurotoxinas/uso terapéutico , Neurotransmisores , Cara
2.
Aesthet Surg J ; 42(11): 1318-1327, 2022 10 13.
Artículo en Inglés | MEDLINE | ID: mdl-35704394

RESUMEN

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 (N = 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 (P < 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; P < 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.


Asunto(s)
Toxinas Botulínicas Tipo A , Fármacos Neuromusculares , Envejecimiento de la Piel , Método Doble Ciego , Femenino , Frente , Humanos , Persona de Mediana Edad , Satisfacción del Paciente , Satisfacción Personal , Resultado del Tratamiento
3.
J Drugs Dermatol ; 20(10): 1052-1060, 2021 Oct 01.
Artículo en Inglés | MEDLINE | ID: mdl-34636520

RESUMEN

BACKGROUND: To further explore clinical trial results indicating increasing doses of botulinum toxin A prolong duration of effect, a 2-stage, phase 2, randomized, double-blind study investigated the duration of effect and safety of incobotulinumtoxinA (INCO; Xeomin®, Bocouture®) doses higher than the US Food and Drug Administration-approved 20 units (U) for glabellar frown lines (GFL). The stage 1 primary efficacy and safety results were reported previously. Here, we report the results of the final analysis (stage 1 and 2), including primary and secondary efficacy and safety endpoints. METHODS: A total of 241 subjects with moderate-to-severe GFL were randomized to receive a single treatment with 20 (N=61), 50 (N=60), 75 (N=61), or 100U (N=59) INCO. The primary efficacy endpoint was duration of ≥ 1-point improvement from baseline assessed by investigator at maximum frown on the Facial Wrinkle Scale. RESULTS: The median duration of effect was 175 days for the 20U group (95% CI 142, 185), 185 days for the 50U group (95% CI 182, 205), 210 days for the 75U group (95% CI 182, 217), and 215 days for the 100U group (95% CI 183, 237). The incidence of treatment-related adverse events was low across all doses and there were no treatment-related serious adverse events. CONCLUSIONS: These results demonstrate that all INCO doses were well tolerated, consistent with the known safety profile of 20U, and increasing dose prolongs the duration of effect for GFL. J Drugs Dermatol. 2021;20(10):1052-1060. doi:10.36849/JDD.6377THIS ARTICLE HAD BEEN MADE AVAILABLE FREE OF CHARGE. PLEASE SCROLL DOWN TO ACCESS THE FULL TEXT OF THIS ARTICLE WITHOUT LOGGING IN. NO PURCHASE NECESSARY. PLEASE CONTACT THE PUBLISHER WITH ANY QUESTIONS.


Asunto(s)
Toxinas Botulínicas Tipo A , Fármacos Neuromusculares , Envejecimiento de la Piel , Toxinas Botulínicas Tipo A/efectos adversos , Método Doble Ciego , Frente , Humanos , Fármacos Neuromusculares/efectos adversos , Resultado del Tratamiento
5.
Aesthet Surg J ; 41(12): 1409-1422, 2021 11 12.
Artículo en Inglés | MEDLINE | ID: mdl-33944905

RESUMEN

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.


Asunto(s)
Toxinas Botulínicas Tipo A , Fármacos Neuromusculares , Envejecimiento de la Piel , Adulto , Toxinas Botulínicas Tipo A/efectos adversos , Método Doble Ciego , Frente , Humanos , Resultado del Tratamiento
6.
J Drugs Dermatol ; 20(1): 10-16, 2021 01 01.
Artículo en Inglés | MEDLINE | ID: mdl-33400419

RESUMEN

The coronavirus pandemic (COVID-19) has served as a call-to-arms in preparing practices for the next disaster whether it is another infectious disease or a flood, hurricane, earthquake, a sustained power outage, or something else. A group of predominantly core aesthetic physicians discussed the various aspects of their office procedures that warrant consideration in a proactive approach to the next pandemic/disaster-related event. This guide does not set a standard of practice but contains recommendations that may avoid some of the "lessons learned" with the COVID-19 pandemic. In this paper, the board-certified core aesthetic physicians classified these recommendations into four generalized areas: Practice Management; Supplies and Inventory; Office Staffing Considerations and Protocols; and Patient Management Strategies. Proactive strategies are provided in each of these categories that, if implemented, may alleviate the processes involved with an efficient office closure and reopening process including, in the case of COVID-19, methods to reduce the risk of transmission to doctors, staff, and patients. These strategies also include being prepared for emergency-related notifications of employees and patients; the acquisition of necessary equipment and supplies such as personal protective equipment; and the maintenance and accessibility of essential data and contact information for patients, vendors, financial advisors, and other pertinent entities.J Drugs Dermatol. 2021;20(1):10-16. doi:10.36849/JDD.5803.


Asunto(s)
COVID-19/prevención & control , Defensa Civil/métodos , Planificación en Desastres/métodos , Desastres/prevención & control , Manejo de la Enfermedad , Rol del Médico , COVID-19/epidemiología , COVID-19/terapia , Defensa Civil/tendencias , Planificación en Desastres/tendencias , Humanos , Admisión y Programación de Personal/tendencias
7.
Aesthet Surg J ; 41(6): NP500-NP511, 2021 05 18.
Artículo en Inglés | MEDLINE | ID: mdl-32722793

RESUMEN

BACKGROUND: IncobotulinumtoxinA is an effective neuromodulator for treating glabellar rhytids. The relationship between dose and reduction in rhytid severity is well established. However, the effects of escalating doses on the treatment duration response are less understood. OBJECTIVES: The aim of this study was to assess the effects of increasing doses of incobotulinumtoxinA on the treatment duration for glabellar rhytids. METHODS: A randomized, double-blind, Phase IV study was conducted at a fully accredited, outpatient surgical facility. Subjects (31 female, 7 male) with moderate to severe glabellar rhytids were randomized to 1 of 3 incobotulinumtoxinA dose groups: 20, 60, or 100 U. Effect duration was determined by calculating the time to return to baseline for dynamic glabellar lines during maximal contraction. Follow-up was completed through 1 year, and adverse events were monitored. RESULTS: The median duration of effect was 120 days (95% confidence interval [CI] [90, 180 days]), 180 days (95% CI [180, 210 days]), and 270 days (95% CI [240, 330 days]) for the 20-, 60-, and 100-U groups, respectively. A Wald chi-square test from the Cox regression on the primary efficacy variable indicated a statistically significant effect of dose group on time to baseline (chi square = 54.63; df = 2; P < 0.001). Hazard ratios were HR = 0.21 (95% CI [0.10; 0.43] for the 60-U vs the 20-U group, and HR = 0.06 (95% CI [0.10; 0.43]) for the 100-U vs the 20-U group, indicating a statistically longer return to baseline for both the 60- and 100-U cohorts. CONCLUSIONS: There is a dose-dependent relationship between incobotulinumtoxinA and duration of effect in the glabella.


Asunto(s)
Toxinas Botulínicas Tipo A , Fármacos Neuromusculares , Envejecimiento de la Piel , Toxinas Botulínicas Tipo A/efectos adversos , Método Doble Ciego , Femenino , Frente , Humanos , Masculino , Resultado del Tratamiento
8.
Aesthet Surg J ; 41(6): NP493-NP499, 2021 05 18.
Artículo en Inglés | MEDLINE | ID: mdl-32506124

RESUMEN

BACKGROUND: Perioral rhytids are a bothersome sign of aging for many patients. Although multiple treatments exist, choosing an optimal modality may be difficult considering that rhytids in this region are fine and the anatomy dynamic. OBJECTIVES: The authors sought to compare the efficacy and safety as well as patient satisfaction of a small-particle hyaluronic acid filler with 0.3% lidocaine (SP-HAL, Restylane Silk) and cohesive polydensified matrix hyaluronic acid filler (CPM-HA, Belotero Balance) in reducing superficial perioral rhytids. METHODS: The study was double-blinded, and 48 patients with moderate to severe superficial perioral rhytids were enrolled. Patients were randomized to receive either CPM-HA in the left perioral region and SPHAL in the right or vice versa. Rhytid severity was measured by patients utilizing a linear analog scale, and by investigators utilizing a validated 5-point scale, for 180 days following treatment. RESULTS: Both SP-HAL and CPM-HA achieved a reduction in rhytid severity, and neither treatment group returned to baseline after 180 days. Investigator-reported scores for rhytid severity were significantly better for SP-HAL than CPM-HA and remained so at 180 days (P < .05). SP-HAL also proved significantly better for reducing rhytids according to patient scores, although this difference occurred between 120 and 180 days only. Adverse events included rash and mild acne for CPM-HA, and SP-HAL was associated with 1 postinflammatory nodule and 2 occurrences of Tyndall effect. CONCLUSIONS: Although both SP-HAL and CPM-HA are effective at reducing perioral rhytid severity and have similar safety profiles, SP-HAL possesses a longer duration of effect.


Asunto(s)
Técnicas Cosméticas , Rellenos Dérmicos , Envejecimiento de la Piel , Técnicas Cosméticas/efectos adversos , Rellenos Dérmicos/efectos adversos , Humanos , Ácido Hialurónico/efectos adversos , Estudios Prospectivos , Resultado del Tratamiento
9.
Dermatol Surg ; 47(4): 504-509, 2021 04 01.
Artículo en Inglés | MEDLINE | ID: mdl-33165057

RESUMEN

BACKGROUND: Real-world re-treatment intervals for botulinum toxins vary, but most subjects receive treatment less frequently than the manufacturer-recommended minimum intervals. In subjects receiving treatment with AbobotulinumtoxinA (ABO) less frequently, high levels of satisfaction and psychosocial improvements in well-being, self-confidence, and quality of life are observed. OBJECTIVE: To evaluate subject satisfaction with a twice yearly re-treatment schedule. METHODS AND MATERIALS: This open-label, multicenter, interventional study evaluated subject satisfaction following injections of ABO 50 U in the glabellar lines at baseline and 6 months. The primary end point was subject satisfaction at 12 months. Secondary endpoints included subject satisfaction, FACE-Q scales, and glabellar line severity scale (GLSS). RESULTS: Ninety-five percent of the 120 subjects were "highly satisfied" or "satisfied" with their treatment outcomes at 12 months. FACE-Q total scores suggested that subjects were less bothered by glabellar lines and felt better about their facial appearance with each treatment versus baseline. Approximately half of subjects had ≥1-grade improvement from baseline in GLSS at 12 months. Median onset of effect was 2 days. CONCLUSION: The majority of subjects (95%) were satisfied with ABO treatment every 6 months; results were supported by high subject satisfaction, long duration, rapid onset, natural-looking results, and overall psychological wellness and safety.


Asunto(s)
Toxinas Botulínicas Tipo A/farmacología , Calidad de Vida , Ritidoplastia/métodos , Envejecimiento de la Piel , Inhibidores de la Liberación de Acetilcolina/farmacología , Adolescente , Adulto , Anciano , Femenino , Estudios de Seguimiento , Humanos , Masculino , Persona de Mediana Edad , Autoimagen , Factores de Tiempo , Adulto Joven
10.
J Drugs Dermatol ; 19(10): 985-991, 2020 10 01.
Artículo en Inglés | MEDLINE | ID: mdl-33026771

RESUMEN

BACKGROUND: Recently reported clinical data provides evidence that increasing the dose of botulinum toxin A increases the duration of efficacy. A 2-stage Phase 2, randomized, double-blind study investigated the duration of effect and safety of IncobotulinumtoxinA (INCO; Xeomin®, Bocouture®; Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany) at doses higher than the approved 20 units (U) for glabellar frown lines (GFL). Primary safety and efficacy endpoints of Stage 1 are reported here. METHODS: 151 subjects with moderate-to-severe GFL were randomized 1:2:2 to receive a single treatment with 20U, 50U, or 75U INCO. The primary efficacy endpoint was median duration of at least 1-point improvement from baseline as assessed by investigator at maximum frown on the Facial Wrinkle Scale. RESULTS: The median duration of effect was 185 days for the 50U dose group (95% CI:[182, 205]) and 210 days for the 75U dose group (95% CI:[182, 217]). Duration of effect was significantly longer for 75U vs 50U (P=0.0400) and 20U (P=0.0166) despite the study not being powered for confirmatory statistical significance testing between the dose groups. Duration of effect was also longer for 50U vs 20U, however; statistical significance was not reached (P=0.4349). The incidence of treatment-related adverse events was low across all doses (20U:2[6.7%], 50U:6[10.0%] and 75U:8[13.1%]). CONCLUSIONS: These results demonstrate a dose effect of at least 6 months duration with higher doses in the majority of GFL subjects. All doses were well tolerated and safety was consistent with the known safety profile of 20U INCO for GFL. J Drugs Dermatol. 2020;19(10):985-991. doi:10.36849/JDD.2020.5454.


Asunto(s)
Toxinas Botulínicas Tipo A/efectos adversos , Técnicas Cosméticas/efectos adversos , Fármacos Neuromusculares/efectos adversos , Envejecimiento de la Piel/efectos de los fármacos , Adulto , Anciano , Toxinas Botulínicas Tipo A/administración & dosificación , Relación Dosis-Respuesta a Droga , Método Doble Ciego , Estética , Músculos Faciales/efectos de los fármacos , Músculos Faciales/inervación , Femenino , Frente , Humanos , Inyecciones Intramusculares , Masculino , Persona de Mediana Edad , Fármacos Neuromusculares/administración & dosificación , Estudios Prospectivos , Factores de Tiempo , Resultado del Tratamiento , Adulto Joven
11.
J Drugs Dermatol ; 19(4): 300-15, 2020 Apr 01.
Artículo en Inglés | MEDLINE | ID: mdl-32401461

RESUMEN

Interest in the cosmetic use of neuromodulators for facial rejuvenation is increasing among physicians, other practitioners, and patients alike, and an expanding array of formulations and reported applications might be helping to drive this trend. Safety, efficacy, and a high level of patient satisfaction can be achieved with all the available botulinum neurotoxin type A (BTXA) products. With any of the formulations, optimal results require knowledge of the individual product’s unique properties and dosing, along with an understanding of the patient’s goals, relevant anatomy, and proper injection technique. This educational activity reviews these topics on the basis of the published literature and expert opinion. A series of case narratives is also included that provides readers with information and insights for achieving success in clinical practice.J Drugs Dermatol. 2020;19(4 Suppl 2):s5-15.

12.
J Drugs Dermatol ; 19(4): s5-s15, 2020 Apr 01.
Artículo en Inglés | MEDLINE | ID: mdl-32243119

RESUMEN

Interest in the cosmetic use of neuromodulators for facial rejuvenation is increasing among physicians, other practitioners, and patients alike, and an expanding array of formulations and reported applications might be helping to drive this trend. Safety, efficacy, and a high level of patient satisfaction can be achieved with all the available botulinum neurotoxin type A (BTXA) products. With any of the formulations, optimal results require knowledge of the individual product's unique properties and dosing, along with an understanding of the patient's goals, relevant anatomy, and proper injection technique. This educational activity reviews these topics on the basis of the published literature and expert opinion. A series of case narratives is also included that provides readers with information and insights for achieving success in clinical practice. J Drugs Dermatol. 2020;19(4 Suppl 2):s5-15.


Asunto(s)
Toxinas Botulínicas Tipo A/administración & dosificación , Técnicas Cosméticas/efectos adversos , Cara/anatomía & histología , Fármacos Neuromusculares/administración & dosificación , Toxinas Botulínicas Tipo A/efectos adversos , Relación Dosis-Respuesta a Droga , Cálculo de Dosificación de Drogas , Estética , Músculos Faciales/efectos de los fármacos , Músculos Faciales/inervación , Femenino , Humanos , Inyecciones Intramusculares/efectos adversos , Inyecciones Intramusculares/métodos , Masculino , Fármacos Neuromusculares/efectos adversos , Satisfacción del Paciente , Rejuvenecimiento , Factores Sexuales , Envejecimiento de la Piel , Resultado del Tratamiento
13.
Aesthet Surg J ; 40(8): 887-891, 2020 07 13.
Artículo en Inglés | MEDLINE | ID: mdl-31996891

RESUMEN

BACKGROUND: Microfocused ultrasound with visualization has become one of the more popular nonsurgical facial rejuvenation therapies available. Although the treatment has gained wide acceptance, providing adequate pain relief during the procedure can be challenging. OBJECTIVES: The aim of this study was to test our hypothesis that nerve blocks prior to treatment would be well tolerated and significantly reduce patient discomfort. METHODS: Subjects undergoing microfocused ultrasound were offered the choice of participating in a split face nerve block, bilateral block, or a control group. Nerves targeted included infraorbital, supratrochlear, supraorbital, zygomaticofrontal, mental, great auricular, and cervical plexus. Pain assessment was based on a 10-point Wong-Backer FACES Pain score. RESULTS: A total of 65 patients were included in the study: 28 in the split face group, 19 in the bilateral block group, and 18 without a block. The mean [standard deviation] pain score of the bilateral block cohort was 3.9 [1.2], and that of the control group was 5.1 [1.7] (P = 0.001). Patients in the split face cohort reported a higher pain score on the unblocked side of the face (7.5 [1.3]) than on the blocked side (2.9 [1.0]) (P < 0.001). The mean pain score for local anesthetic injection was 2.7 and 1.4 for the split face and the bilateral groups, respectively. There were no adverse events. CONCLUSIONS: Nerve blocks are well tolerated and significantly improve patient comfort during microfocused ultrasound treatment without compromising outcomes or increasing adverse events.


Asunto(s)
Bloqueo Nervioso , Anestésicos Locales/efectos adversos , Humanos , Bloqueo Nervioso/efectos adversos , Dolor , Dimensión del Dolor , Ultrasonografía Intervencional
14.
Aesthet Surg J ; 40(7): 767-777, 2020 06 15.
Artículo en Inglés | MEDLINE | ID: mdl-31346621

RESUMEN

BACKGROUND: Juvéderm Vollure XC (VYC-17.5L; Allergan plc, Dublin, Ireland) belongs to a family of hyaluronic acid gels based on the Vycross technology platform. OBJECTIVES: The authors sought to evaluate the safety and effectiveness of Vollure for correction of moderate to severe nasolabial folds (NLFs) over 18 months and after repeat treatment. METHODS: In this prospective, randomized study, patients (N = 123) received initial/touch-up treatment with Vollure in 1 NLF and control filler in the contralateral NLF. Patients received optional repeat treatment with Vollure after month 12, 15, or 18. Assessments included investigator-rated NLF Severity Scale responder rates (≥1-point improvement vs baseline), patient-assessed Appraisal of Nasolabial Folds scale of the FACE-Q questionnaire, and patient satisfaction (11-point scale). RESULTS: Median volume of Vollure injected was 1.7 mL for initial/touch-up treatment combined and 0.6 mL for repeat treatment. The NLF Severity Scale responder rates were 93%, 85%, and 59% at months 6, 9, and 18 after initial/touch-up treatment and increased to 94% at 1 month after repeat treatment. Mean patient-reported FACE-Q scores significantly improved from baseline at all timepoints. Most patients were very satisfied with treatment at all timepoints from day 3 (75%) through month 18 (68%) and at 1 month after repeat treatment (94%). Common injection site responses after initial/touch-up and repeat treatment were firmness, swelling, and tenderness to touch; most were mild/moderate. CONCLUSIONS: Vollure was safe and effective for correction of moderate to severe NLFs, with results lasting 18 months in 59% of NLFs. Repeat treatment required one-third of the injection volume to achieve similar improvement in NLF severity as initial/touch-up treatment.


Asunto(s)
Técnicas Cosméticas , Ácido Hialurónico , Envejecimiento de la Piel , Técnicas Cosméticas/efectos adversos , Humanos , Surco Nasolabial , Satisfacción del Paciente , Estudios Prospectivos , Resultado del Tratamiento
15.
Dermatol Surg ; 46(1): 61-69, 2020 01.
Artículo en Inglés | MEDLINE | ID: mdl-31356432

RESUMEN

BACKGROUND: The aesthetic use of botulinum toxins is widely accepted in routine treatment of glabellar lines. OBJECTIVE: To strengthen existing efficacy and safety data, and examine subject satisfaction concerning abobotulinumtoxinA (ABO) treatment for moderate to severe glabellar lines. MATERIALS AND METHODS: A 150-day prospective, single-dose, multicenter, randomized, parallel-group, placebo-controlled, double-blind study of 300 subjects treated with ABO (50 Units [U]). Response was defined as having no or mild glabellar lines after treatment (primary objective was Day 30 response). Glabellar line severity, onset and duration of effect, satisfaction, treatment emergent adverse events (TEAEs), and treatment-related adverse events (TRAEs) were assessed. RESULTS: Median time to onset of effect was 2 days. Day 30, ABO treatment response was 89% and 85% for investigator and subject assessments, respectively (p < .001 vs placebo). At Day 120, 60% of subjects demonstrated ≥1 grade improvement and 45% at Day 150. Subject satisfaction concerning glabellar line appearance was high (93%) at Day 14 and maintained by 35% through Day 150 with ABO treatment. No serious AEs were related to study treatment. CONCLUSION: Most ABO-treated subjects sustained ≥1 grade glabellar line improvements over 120 days, and satisfaction was maintained by >30% of subjects throughout 150 days. ABO was well tolerated.


Asunto(s)
Toxinas Botulínicas Tipo A/uso terapéutico , Técnicas Cosméticas , Frente , Fármacos Neuromusculares/uso terapéutico , Envejecimiento de la Piel , Adulto , Anciano , Método Doble Ciego , Femenino , Humanos , Masculino , Persona de Mediana Edad , Satisfacción del Paciente , Factores de Tiempo , Resultado del Tratamiento , Adulto Joven
16.
J Drugs Dermatol ; 18(11): 1109-1114, 2019 Nov 01.
Artículo en Inglés | MEDLINE | ID: mdl-31741353

RESUMEN

Objective: To assess the effectiveness of microfocused ultrasound with visualization (MFU-V) for treating moderate to severe atrophic acne scars. Design: Healthy subjects (N=20) seeking correction of moderate to severe atrophic acne scars on the cheeks and/or temples were enrolled. Scars were predominantly rolling- and boxcar-type, affecting an area ≥5.0cm2. Eighteen subjects completed the study. Intervention: The treatment area was marked with 14mm2 and 25mm2 squares and treated with four transducers: 7 MHz (3.0mm focal depth) and 10 MHz (1.5mm focal depth), each in 14mm and 25mm widths. During each session, MFU-V treatment lines were applied 2-3mm apart, within each treatment area, with a maximum length of 25mm. Each square received 30 treatment lines at two transducer depths (60 total lines). Subjects received three total treatments, with 30 days between each session. The primary outcome measure was improvement in baseline appearance of scars at 90 and 180 days after the final treatment. Secondary outcome measures included changes in severity using an Acne Scar Improvement Scale (ASIS) and Global Aesthetic Improvement Scale (GAIS) at 60-, 90-, and 180-days post-treatment, and a satisfaction questionnaire at 90-days post-treatment. Results: Among the 90-day images available for assessments (n=11), 100% were rated as improved by blinded reviewers, and 64% of pre- and post-treatment images were correctly selected. Among 180-day images (n=15), 100% were rated as improved, and 40% of pre- and post-treatment images were correctly selected. Most subjects were determined to have 25-50% improvement in investigator ASIS scores at 60-, 90-, and 180-days post-treatment. All subjects noted some improvement in severity at the 60-day assessment when measured using ASIS. Based on investigator GAIS scores, 100% of subjects were "Improved" or "Much Improved" at 60-, 90-, and 180-days post-treatment. Based on subject GAIS scores, all subjects noted improvement at the 60-day assessment, and 83% and 89% at the 90- and 180-day assessments, respectively. Overall, 17 subjects (94.4%) expressed some degree of satisfaction at 90-days post-treatment. Conclusions: The results of this study demonstrated that MFU-V therapy is beneficial and well tolerated for the treatment of rolling- and boxcar-type acne scars. J Drugs Dermatol. 2019;18(11):1109-1114.


Asunto(s)
Acné Vulgar/terapia , Cicatriz/patología , Terapia por Ultrasonido , Acné Vulgar/patología , Adolescente , Adulto , Anciano , Atrofia , Femenino , Humanos , Masculino , Persona de Mediana Edad , Índice de Severidad de la Enfermedad , Resultado del Tratamiento , Adulto Joven
17.
Facial Plast Surg Clin North Am ; 27(3): 419-423, 2019 Aug.
Artículo en Inglés | MEDLINE | ID: mdl-31280857

RESUMEN

Best practices in fat transfer to the face focus on tissue harvest and processing techniques. This article discusses the role of adipose-derived mesenchymal stem cells (MSCs) in mitigating tissue loss in grafting. Discrepancies among common practice and recent study results have propagated uncertainty with long-term results. Fortunately, recent increases in the understanding of these MSCs are leading providers to identify statistically more favorable tissue donor sites, harvest technique, and preparation methods to increase their concentration in transferred tissue. Future studies are needed to support or confound the long-term effects of MSC transfer on facial fat grafting.


Asunto(s)
Tejido Adiposo/trasplante , Rejuvenecimiento , Envejecimiento de la Piel , Recolección de Tejidos y Órganos/métodos , Trasplante Autólogo , Humanos
18.
J Drugs Dermatol ; 18(1): 52-57, 2019 01 01.
Artículo en Inglés | MEDLINE | ID: mdl-30681794

RESUMEN

Aesthetic dermatologic applications of botulinum neurotoxin (BoNT), including treatment of glabellar lines, horizontal forehead lines, and crow's feet, were the most common non-surgical cosmetic procedures in the US in 2017, with high levels of subject satisfaction. Since the first BoNT type A (BoNT-A) formulation was approved in 1989, the number of formulations available on the world's commercial markets has increased and new approvals are expected. BoNT is produced by Clostridium botulinum in nature as part of a large protein complex. However, the unnecessary clostridial proteins, which dissociate from BoNT under physiological conditions with a half-life of <1 minute, have no role in clinical applications. Data demonstrate that BoNT administration can elicit an immunological response, leading to production of neutralizing antibodies that can be associated with reduced efficacy or treatment non-response. As repeat treatments are required to maintain efficacy, clinicians should be aware of the possibility of antibody development and choose a BoNT with the lowest risk of immunogenicity. IncobotulinumtoxinA is manufactured using advanced technology to precisely isolate the pure BoNT without unnecessary clostridial proteins, and with low immunogenicity and high specific activity. In incobotulinumtoxinA clinical studies, no previously BoNT-naïve subjects developed neutralizing antibodies, and there was no secondary non-response to incobotulinumtoxinA treatment. Here we review the role of unnecessary clostridial proteins in BoNT-A and discuss the unique incobotulinumtoxinA manufacturing and purification process with a focus on the implications for use in aesthetic medicine. J Drugs Dermatol. 2019;18(1):52-57.


Asunto(s)
Toxinas Botulínicas Tipo A/administración & dosificación , Fármacos Neuromusculares/administración & dosificación , Envejecimiento de la Piel , Toxinas Botulínicas Tipo A/química , Toxinas Botulínicas Tipo A/inmunología , Técnicas Cosméticas , Humanos , Inyecciones Intramusculares , Fármacos Neuromusculares/química , Fármacos Neuromusculares/inmunología
20.
Facial Plast Surg ; 31(1): 29-34, 2015 Feb.
Artículo en Inglés | MEDLINE | ID: mdl-25763894

RESUMEN

With an increasing understanding of the aging process and the rapidly growing interest in minimally invasive treatments, injectable facial fillers have changed the perspective for the treatment and rejuvenation of the aging face. Other than autologous fat and certain preformed implants, the collagen family products were the only Food and Drug Administration approved soft tissue fillers. But the overwhelming interest in soft tissue fillers had led to the increase in research and development of other products including bioengineered nonpermanent implants and permanent alloplastic implants. As multiple injectable soft tissue fillers and biostimulators are continuously becoming available, it is important to understand the biophysical properties inherent in each, as these constitute the clinical characteristics of the product. This article will review the materials and properties of the currently available soft tissue fillers: hyaluronic acid, calcium hydroxylapatite, poly-l-lactic acid, polymethylmethacrylate, and autologous fat (and aspirated tissue including stem cells).


Asunto(s)
Rellenos Dérmicos , Ácido Hialurónico/análogos & derivados , Ácido Láctico , Polímeros , Tejido Adiposo/trasplante , Celulosa/farmacología , Colágeno/farmacología , Rellenos Dérmicos/farmacología , Durapatita/farmacología , Cara , Geles , Humanos , Ácido Hialurónico/farmacología , Ácido Láctico/farmacología , Manitol/farmacología , Microesferas , Tamaño de la Partícula , Poliésteres , Polímeros/farmacología , Polimetil Metacrilato/farmacología , Rejuvenecimiento , Trasplante Autólogo
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