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1.
Aesthetic Plast Surg ; 2024 Mar 18.
Artículo en Inglés | MEDLINE | ID: mdl-38499877

RESUMEN

PURPOSE: This synaptic systemised review critically examines the provision of aesthetic medical care to LGBTQIA+ (lesbian, gay, bisexual, transgender, queer or questioning, intersex, asexual, and more) individuals, assessing both the clinical practices and the educational frameworks that guide interactions with LGBTQIA+ patients in aesthetic settings. METHODS: Following PRISMA-S guidelines, a comprehensive review was conducted, initially identifying 159 potentially relevant articles. Upon stringent full-text review, 33 studies met the inclusion criteria and were subject to an in-depth thematic analysis. The scope encompassed qualitative studies, quantitative analyses, and a cross section of interdisciplinary research, predominantly from Western settings. RESULTS: The analysis distilled four principal themes: the imperative of identity affirmation in aesthetic interventions, substantial barriers to inclusive and empathetic care, the critical need for patient empowerment, and the existing deficiencies within medical education regarding LGBTQIA+ care. These themes highlight a complex interplay between the clinical aspirations of LGBTQIA+ individuals and the current capacity of aesthetic medicine to cater to this diversity. CONCLUSIONS: There is a pressing need for a paradigmatic shift towards more inclusive, competent, and sensitive aesthetic medical care for LGBTQIA+ patients. It underscores the necessity of reform in medical education and advocates for policy changes that promote a more equitable healthcare environment. This research serves as a call to action, emphasizing the ethical imperative to integrate comprehensive LGBTQIA+ care competencies into aesthetic medicine curricula and practice. LEVEL OF EVIDENCE IV: This journal requires that authors assign a level of evidence to each article. For a full description of these Evidence-Based Medicine ratings, please refer to the Table of Contents or the online Instructions to Authors www.springer.com/00266.

2.
Aesthet Surg J ; 43(2): 215-229, 2023 02 03.
Artículo en Inglés | MEDLINE | ID: mdl-36099476

RESUMEN

BACKGROUND: Onabotulinumtoxin A (Onabot A) was the first treatment to be approved for aesthetic indications, namely glabellar lines (GLs), crow's feet lines (CFLs), and forehead lines (FHLs), with a cumulative dose of 64 U. OBJECTIVES: The aim of this study was to conduct a meta-analysis to combine the available data for approved doses for GLs, CFLs, and FHLs to explore the effect and duration of simultaneous treatment with Onabot A. METHODS: PubMed/MEDLINE, Embase, and other national clinical trial registries were searched for randomized controlled trials from January 2010 to July 2022. The meta-analysis, trial sequential analysis, and investigator-assessed time to return to nonresponder status in GLs, CFLs, and FHLs following Onabot A were plotted to elicit a cumulative dose-adjusted response curve based on Kaplan-Meier analysis with a log-rank test. RESULTS: Fourteen randomized controlled trials were eligible for quantitative analysis. A total of 8369 subjects were recruited across the trials. The meta-analysis results show that Onabot A is very effective in reducing moderate to severe GLs, CFLs, and FHLs. The cumulative Z-curve for GLs, CFLs, and FHLs also exceeds the required information size (RIS). Kaplan-Meier analysis with a log-rank test demonstrated that simultaneous treatment of GLs, CFLs, and FHLs requires 182 days (95% CI = 179, 215 days) (P < 0.00002) to return to nonresponder status. CONCLUSIONS: Treatment of the upper facial expression lines with Onabot A is effective, and the approved cumulative dose of 64 U gives longer-lasting effects.


Asunto(s)
Toxinas Botulínicas Tipo A , Fármacos Neuromusculares , Envejecimiento de la Piel , Humanos , Expresión Facial , Ensayos Clínicos Controlados Aleatorios como Asunto , Frente , Fármacos Neuromusculares/uso terapéutico , Resultado del Tratamiento
3.
J Am Acad Dermatol ; 83(1): 86-95, 2020 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-32035107

RESUMEN

BACKGROUND: Recent publications have suggested an increased risk of delayed adverse events (DAEs) with a smooth, cohesive 20-mg/mL hyaluronic acid filler, Juvéderm Voluma (HA-V). OBJECTIVE: To examine the occurrence of HA-V DAEs and identify patterns and characteristics. METHODS: Charts from patients who received HA-V between February 1, 2009, and February 28, 2018 from 2 clinics were analyzed. RESULTS: In 4500 patients who received 9324 treatments with HA-V, 44 DAEs were identified, for a combined incidence of 0.98% per patient, 0.47% per treatment, and 0.23% per syringe. Patients with DAEs received a slightly larger cumulative amount of HA-V than those who did not. Delayed swelling and nodule formation were the most common reactions and occurred a median of 4 months after treatment, with an increase in frequency between October and January. About a third were preceded by an identifiable immunologic stimulus. DAEs were transient and resolved without incident. LIMITATIONS: The retrospective nature made it difficult to capture time to resolution or remember potential triggers. CONCLUSION: In this large, long-term, retrospective review, HA-V DAEs occurred at a rate of 0.98% per patient. Although the exact cause has yet to be elucidated, we hypothesize that an increase in fragmentation during the HA-V degradation process may trigger an inflammatory response after an immunologic trigger.


Asunto(s)
Técnicas Cosméticas/efectos adversos , Rellenos Dérmicos/efectos adversos , Dermatosis Facial/inducido químicamente , Ácido Hialurónico/efectos adversos , Adulto , Anciano , Edema/inducido químicamente , Eritema/inducido químicamente , Femenino , Humanos , Masculino , Persona de Mediana Edad , Dolor/inducido químicamente , Estudios Retrospectivos , Piel/patología , Factores de Tiempo
4.
Dermatol Surg ; 45(7): 941-948, 2019 07.
Artículo en Inglés | MEDLINE | ID: mdl-30893157

RESUMEN

BACKGROUND: Highly purified liquid-injectable silicone (LIS) has been established as a permanent agent for off-label correction of HIV-associated facial lipoatrophy (HIV-FLA). However, controversy exists about long-term safety. OBJECTIVE: To establish the safety and efficacy at 10 years or greater of LIS for HIV-FLA. METHODS: Patients from 3 practices with 10-year or greater in-person office follow-up were analyzed to determine the number of LIS treatments and total volume required to achieve optimal correction. The nature of any treated adverse events was noted. RESULTS: One hundred sixty-four patients had 10-year or greater in-office follow-up. All subjects maintained long-term correction with an average of 9 treatments, average of 1.56 mL per treatment, and an average total of 14.1 mL. Two patients had severe adverse events manifesting as temporary facial edema. Four patients experienced mild-to-moderate excess fibroplasia presenting as perceived overcorrection, and 6 patients had nondisfiguring subcutaneous firmness. All adverse events were successfully treatable, mostly with intralesional 5-fluorouracil and triamcinolone. CONCLUSION: Liquid-injectable silicone is an effective long-term treatment option for HIV-FLA. When injected in small quantities with the microdroplet serial puncture technique at monthly or greater intervals, optimal correction appears durable for more than 10 years. Adverse events consisted mostly of excess fibroplasia and were treatable.


Asunto(s)
Técnicas Cosméticas , Dimetilpolisiloxanos/administración & dosificación , Dermatosis Facial/terapia , Síndrome de Lipodistrofia Asociada a VIH/terapia , Siliconas/administración & dosificación , Materiales Biocompatibles/administración & dosificación , Estudios de Cohortes , Estudios de Seguimiento , Humanos , Inyecciones Subcutáneas , Masculino , Factores de Tiempo
5.
Aesthet Surg J ; 39(6): 662-674, 2019 05 16.
Artículo en Inglés | MEDLINE | ID: mdl-30805636

RESUMEN

BACKGROUND: Sudden loss of vision secondary to filler treatments is a rare but catastrophic complication. OBJECTIVES: The aim of this study was to update the published cases of blindness after filler injection that have occurred since we published our review of 98 cases in 2015, and to discuss prevention and management strategies. METHODS: A literature review was performed to identify all cases of visual complications caused by filler injection identified between January 2015 and September 2018. RESULTS: Forty-eight new published cases of partial or complete vision loss after filler injection were identified. The sites that were highest risk were the nasal region (56.3%), glabella (27.1%), forehead (18.8%), and nasolabial fold (14.6%). Hyaluronic acid filler was the cause of this complication in 81.3% of cases. Vision loss, pain, ophthalmoplegia, and ptosis were the most common reported symptoms. Skin changes were seen in 43.8% of cases and central nervous system complications were seen in 18.8% of cases. Ten cases (20.8%) experienced complete recovery of vision, whereas 8 cases (16.7%) reported only partial recovery. Management strategies varied greatly and there were no treatments that were shown to be consistently successful. CONCLUSIONS: Although the risk of blindness from fillers is rare, practitioners who inject filler should have a thorough knowledge of this complication including prevention and management strategies.


Asunto(s)
Ceguera/etiología , Ceguera/terapia , Rellenos Dérmicos/efectos adversos , Humanos , Infarto/etiología , Oclusión de la Arteria Retiniana/etiología
7.
Dermatol Surg ; 43(11): 1321-1331, 2017 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-28614091

RESUMEN

BACKGROUND: Injectable daxibotulinumtoxinA (RT002) is an investigational botulinum toxin Type A in clinical development. It is formulated with a proprietary peptide and offers the potential of a longer acting neurotoxin therapy. OBJECTIVE: To compare the safety, efficacy, and duration of response of daxibotulinumtoxinA with onabotulinumtoxinA and placebo [www.clinicaltrials.gov NCT02303002]. METHODS: In this Phase 2, randomized, dose-ranging, parallel-group, double-blind, multicenter study, subjects with moderate or severe glabellar lines at maximum frown were randomly assigned to 20U, 40U, or 60U daxibotulinumtoxinA, 20U onabotulinumtoxinA, or placebo. Glabellar line severity was evaluated by investigators and subjects at least every 4 weeks, for at least 24 weeks. RESULTS: Overall, 268 subjects enrolled. Statistical and clinical superiority were observed for 40U and 60U daxibotulinumtoxinA over 20U onabotulinumtoxinA for a range of efficacy outcomes despite the study not being powered to detect statistically significant differences between these active treatment groups. CONCLUSION: The 40U dose of daxibotulinumtoxinA was well tolerated (e.g., absence of ptosis) and had the most favorable risk: benefit profile. Compared with 20U onabotulinumtoxinA, it exhibited a significantly greater response rate and a significantly longer duration of response (median of 24 weeks vs 19 weeks; p = .030).


Asunto(s)
Toxinas Botulínicas Tipo A/uso terapéutico , Fármacos Neuromusculares/uso terapéutico , Envejecimiento de la Piel/efectos de los fármacos , Toxinas Botulínicas Tipo A/administración & dosificación , Relación Dosis-Respuesta a Droga , Método Doble Ciego , Femenino , Humanos , Inyecciones Intramusculares , Masculino , Persona de Mediana Edad , Fármacos Neuromusculares/administración & dosificación , Resultado del Tratamiento
8.
Dermatol Surg ; 42 Suppl 2: S89-93, 2016 May.
Artículo en Inglés | MEDLINE | ID: mdl-27128250

RESUMEN

BACKGROUND: Facial aging is multifactorial, including changes in all the anatomical layers of the face including bone, fat, connective tissues and skin. METHODS: An evaluation of the multifactorial causation of facial aging pointed to the need for a multifactorial approach to restoration and rejuvenation of the aging human face. RESULTS: The varied aetiologies of the expressions of facial aging require more interventions than a unipolar approach. Combinations of neuromodulators, three and two-dimensional fillers and energy based devices were discussed. Surgical interventions were also discussed but were not addressed in this paper. CONCLUSIONS: A multimodal approach to lower facial rejuvenation and restoration is discussed as the most effective and appropriate method to achieve noninvasive aesthetic treatment success.


Asunto(s)
Rejuvenecimiento , Envejecimiento de la Piel , Toxinas Botulínicas Tipo A/uso terapéutico , Colágeno/biosíntesis , Terapia Combinada , Rellenos Dérmicos/uso terapéutico , Ultrasonido Enfocado de Alta Intensidad de Ablación , Humanos , Tratamiento de Luz Pulsada Intensa , Lentigo/terapia , Fármacos Neuromusculares/uso terapéutico , Terapia por Radiofrecuencia , Enfermedades de la Piel/terapia , Telangiectasia/terapia
9.
Dermatol Surg ; 42(9): 1094-101, 2016 Sep.
Artículo en Inglés | MEDLINE | ID: mdl-27427996

RESUMEN

BACKGROUND: OnabotulinumtoxinA has demonstrated the ability to eliminate mild glabellar lines at rest; however, less is known regarding the effect of repeat treatment on more severe lines at rest. OBJECTIVE: To assess the effect of repeated onabotulinumtoxinA treatment for reduction of glabellar lines at rest. METHODS: Subjects 18 to 75 years old with at least mild glabellar lines at rest, as assessed by the validated Facial Wrinkle Scale (FWS) with photonumeric guide (score ≥ 1), received 3 treatments of 20 U onabotulinumtoxinA 4 months apart (N = 225). "Response" was defined as elimination of glabellar lines at rest (FWS score = 0) at any time point (Days 7, 30, 60, 90, and 120). Effect of treatment cycle on response was analyzed using repeated measures logistic regressions (p < .05). RESULTS: Most subjects were female (85%) and white (88%) (age range: 35-54 years). The likelihood of significant response was as follows: for all subjects combined (odds ratio [OR]: 1.31), for subjects with mild resting lines at baseline (OR: 1.49), and for older women (≥55 years) with mild resting lines at baseline (OR: 2.22). Of all subjects, 76% responded after 1 treatment, and 45% responded in all 3 cycles. CONCLUSION: Subjects repeatedly treated with onabotulinumtoxinA showed progressive improvement in glabellar lines at rest.


Asunto(s)
Toxinas Botulínicas Tipo A/administración & dosificación , Fármacos Neuromusculares/administración & dosificación , Envejecimiento de la Piel , Adulto , Factores de Edad , Técnicas Cosméticas , Esquema de Medicación , Femenino , Frente , Humanos , Masculino , Persona de Mediana Edad , Descanso , Retratamiento
10.
Dermatol Surg ; 42 Suppl 1: S195-S202, 2016 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-27661741

RESUMEN

BACKGROUND: A validated scale is needed for objective and reproducible comparisons of hand appearance before and after treatment in practice and clinical studies. OBJECTIVE: To describe the development and validation of the 5-point photonumeric Allergan Hand Volume Deficit Scale. METHODS: The scale was developed to include an assessment guide, verbal descriptors, morphed images, and real-subject images for each grade. The clinical significance of a 1-point score difference was evaluated in a review of image pairs representing varying differences in severity. Interrater and intrarater reliability was evaluated in a live-subject validation study (N = 296) completed during 2 sessions occurring 3 weeks apart. RESULTS: A score difference of ≥1 point was shown to reflect a clinically significant difference (mean [95% confidence interval] absolute score difference, 1.12 [0.99-1.26] for clinically different image pairs and 0.45 [0.33-0.57] for not clinically different pairs). Intrarater agreement between the 2 validation sessions was almost perfect (mean weighted kappa = 0.83). Interrater agreement was almost perfect during the second session (0.82, primary end point). CONCLUSION: The Allergan Hand Volume Deficit Scale is a validated and reliable scale for physician rating of hand volume deficit.


Asunto(s)
Pesos y Medidas Corporales/métodos , Mano/patología , Fotograbar , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Mano/anatomía & histología , Humanos , Masculino , Persona de Mediana Edad , Variaciones Dependientes del Observador , Tamaño de los Órganos , Reproducibilidad de los Resultados , Índice de Severidad de la Enfermedad , Adulto Joven
11.
Dermatol Surg ; 42 Suppl 1: S211-S218, 2016 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-27661743

RESUMEN

BACKGROUND: A validated scale is needed for objective and reproducible comparisons of chin appearance before and after chin augmentation in practice and clinical studies. OBJECTIVE: To describe the development and validation of the 5-point photonumeric Allergan Chin Retrusion Scale. METHODS: The Allergan Chin Retrusion Scale was developed to include an assessment guide, verbal descriptors, morphed images, and real subject images for each scale grade. The clinical significance of a 1-point score difference was evaluated in a review of multiple image pairs representing varying differences in severity. Interrater and intrarater reliability was evaluated in a live-subject validation study (N = 298) completed during 2 sessions occurring 3 weeks apart. RESULTS: A difference of ≥1 point on the scale was shown to reflect a clinically meaningful difference (mean [95% confidence interval] absolute score difference, 1.07 [0.94-1.20] for clinically different image pairs and 0.51 [0.39-0.63] for not clinically different pairs). Intrarater agreement between the 2 live-subject validation sessions was substantial (mean weighted kappa = 0.79). Interrater agreement was substantial during the second rating session (0.68, primary end point). CONCLUSION: The Allergan Chin Retrusion Scale is a validated and reliable scale for physician rating of severity of chin retrusion.


Asunto(s)
Pesos y Medidas Corporales/métodos , Mentón/anomalías , Fotograbar , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Mentón/anatomía & histología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Variaciones Dependientes del Observador , Reproducibilidad de los Resultados , Índice de Severidad de la Enfermedad , Adulto Joven
12.
Dermatol Surg ; 42 Suppl 1: S219-S226, 2016 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-27661744

RESUMEN

BACKGROUND: A validated scale is needed for objective and reproducible comparisons of facial skin roughness before and after aesthetic treatment in practice and in clinical studies. OBJECTIVE: To describe the development and validation of the 5-point photonumeric Allergan Skin Roughness Scale. METHODS: The scale was developed to include an assessment guide, verbal descriptors, morphed images, and real subject images for each grade. The clinical significance of a 1-point score difference was evaluated in a review of image pairs representing varying differences in severity. Interrater and intrarater reliability was evaluated in a live-subject validation study (N = 290) completed during 2 sessions occurring 3 weeks apart. RESULTS: A score difference of ≥1 point was shown to reflect a clinically meaningful difference (mean [95% confidence interval] absolute score difference 1.09 [0.96-1.23] for clinically different image pairs and 0.53 [0.38-0.67] for not clinically different pairs). Intrarater agreement between the 2 validation sessions was almost perfect (weighted kappa = 0.83). Interrater agreement was almost perfect during the second rating session (0.81, primary end point). CONCLUSION: The Allergan Skin Roughness Scale is a validated and reliable scale for physician rating of midface skin roughness.


Asunto(s)
Fotograbar , Piel/patología , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Cara , Femenino , Humanos , Masculino , Persona de Mediana Edad , Variaciones Dependientes del Observador , Reproducibilidad de los Resultados , Índice de Severidad de la Enfermedad , Piel/anatomía & histología , Adulto Joven
13.
Dermatol Surg ; 42 Suppl 1: S227-S234, 2016 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-27661745

RESUMEN

BACKGROUND: A validated scale is needed for objective and reproducible comparisons of facial fine lines before and after treatment in practice and clinical studies. OBJECTIVE: To describe the development and validation of the 5-point photonumeric Allergan Fine Lines Scale. METHODS: The Allergan Fine Lines Scale was developed to include an assessment guide, verbal descriptors, morphed images, and real subject images for each scale grade. The clinical significance of a 1-point score difference was evaluated in a review of multiple image pairs representing varying differences in severity. Interrater and intrarater reliability was evaluated in a live subject validation study (N = 289) completed during 2 sessions occurring 3 weeks apart. RESULTS: A score difference of ≥1 point was shown to reflect a clinically significant difference (mean [95% CI] absolute score difference, 1.06 [0.92-1.21] for clinically different image pairs and 0.50 [0.38-0.61] for not clinically different pairs). Intrarater agreement between the 2 live subject validation sessions was almost perfect (weighted kappa = 0.85). Interrater agreement was substantial during the second rating session (0.76, primary end point). CONCLUSION: The Allergan Fine Lines Scale is a validated and reliable scale for physician rating of severity of superficial fine lines.


Asunto(s)
Cara/anatomía & histología , Fotograbar/métodos , Envejecimiento de la Piel , Técnicas Cosméticas , Estética , Femenino , Humanos , Masculino
14.
Dermatol Surg ; 42 Suppl 1: S203-S210, 2016 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-27661742

RESUMEN

BACKGROUND: A validated scale is needed for objective and reproducible comparisons of temple appearance before and after aesthetic treatment in practice and clinical studies. OBJECTIVE: To describe the development and validation of the 5-point photonumeric Allergan Temple Hollowing Scale. METHODS: The scale was developed to include an assessment guide, verbal descriptors, morphed images, and real subject images for each grade. The clinical significance of a 1-point score difference was evaluated in a review of image pairs representing varying differences in severity. Interrater and intrarater reliability was evaluated in a live-subject validation study (N = 298) completed during 2 sessions occurring 3 weeks apart. RESULTS: A score difference of ≥1 point was shown to reflect a clinically significant difference (mean [95% confidence interval] absolute score difference, 1.1 [0.94-1.26] for clinically different image pairs and 0.67 [0.51-0.83] for not clinically different pairs). Intrarater agreement between the 2 validation sessions was almost perfect (mean weighted kappa = 0.86). Interrater agreement was almost perfect during the second session (0.81, primary endpoint). CONCLUSION: The Allergan Temple Hollowing Scale is a validated and reliable scale for physician rating of temple volume deficit.


Asunto(s)
Pesos y Medidas Corporales/métodos , Cara/patología , Fotograbar , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Cara/anatomía & histología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Variaciones Dependientes del Observador , Tamaño de los Órganos , Reproducibilidad de los Resultados , Índice de Severidad de la Enfermedad , Hueso Esfenoides , Hueso Temporal , Adulto Joven
15.
Dermatol Surg ; 42 Suppl 1: S235-S242, 2016 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-27661746

RESUMEN

BACKGROUND: A validated scale is needed for objective and reproducible comparisons of horizontal neck lines before and after treatment in practice and clinical studies. OBJECTIVE: To describe the development and validation of the 5-point photonumeric Allergan Transverse Neck Lines Scale. METHODS: The Allergan Transverse Neck Lines Scale was developed to include an assessment guide, verbal descriptors, morphed images, and real subject images for each scale grade. The clinical significance of a 1-point score difference was evaluated in a review of multiple image pairs representing varying differences in severity. Interrater and intrarater reliability was evaluated in a live-subject rating validation study (N = 297) completed during 2 sessions occurring 3 weeks apart. RESULTS: A difference of ≥1 point on the scale was shown to reflect a clinically significant difference (mean [95% confidence interval] absolute score difference, 1.22 [1.09-1.35] for clinically different image pairs and 0.57 [0.42-0.72] for not clinically different pairs). Intrarater agreement between the 2 live-subject rating validation sessions was substantial (mean weighted kappa = 0.78). Interrater agreement was substantial during the second rating session (0.73, primary end point). CONCLUSION: The Allergan Transverse Neck Lines Scale is a validated and reliable scale for rating of severity of neck lines.


Asunto(s)
Fotograbar , Piel/patología , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Humanos , Masculino , Persona de Mediana Edad , Cuello , Variaciones Dependientes del Observador , Reproducibilidad de los Resultados , Índice de Severidad de la Enfermedad , Adulto Joven
16.
Dermatol Surg ; 42 Suppl 1: S243-S250, 2016 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-27661747

RESUMEN

BACKGROUND: A validated scale is needed for objective and reproducible comparisons of static forehead lines before and after treatment in practice and clinical studies. OBJECTIVE: To describe the development and validation of the 5-point photonumeric Allergan Forehead Lines Scale. METHODS: The Allergan Forehead Lines Scale was developed to include an assessment guide, verbal descriptors, morphed images, and real subject images for each scale grade. The clinical significance of a 1-point score difference was evaluated in a review of multiple image pairs representing varying differences in severity. Interrater and intrarater reliability was evaluated in a live-subject validation study (N = 295) completed during 2 sessions occurring 3 weeks apart. RESULTS: A difference of ≥1 point on the scale was shown to reflect a clinically significant difference (mean [95% confidence interval] absolute score difference, 1.06 [0.91-1.21] for clinically different image pairs and 0.38 [0.26-0.51] for not clinically different pairs). Intrarater agreement between the 2 live-subject validation sessions was almost perfect (mean weighted kappa = 0.87). Interrater agreement was almost perfect during the second rating session (0.86, primary end point). CONCLUSION: The Allergan Forehead Lines Scale is a validated and reliable scale for physician rating of static horizontal forehead lines.


Asunto(s)
Frente/patología , Fotograbar , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Frente/anatomía & histología , Humanos , Masculino , Persona de Mediana Edad , Variaciones Dependientes del Observador , Reproducibilidad de los Resultados , Índice de Severidad de la Enfermedad , Adulto Joven
17.
Dermatol Surg ; 42 Suppl 1: S251-S258, 2016 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-27661748

RESUMEN

BACKGROUND: A validated scale is needed for objective and reproducible comparisons of infraorbital hollows (i.e., tear troughs) before and after treatment in practice and clinical studies. OBJECTIVE: To describe the development and validation of the 5-point photonumeric Allergan Infraorbital Hollows Scale. METHODS: The scale was developed to include an assessment guide, verbal descriptors, morphed images, and real subject images for each grade. The clinical significance of a 1-point score difference was evaluated in a review of image pairs representing varying differences in severity. Interrater and intrarater reliability was evaluated in a live-subject validation study (N = 297) completed during 2 sessions occurring 3 weeks apart. RESULTS: A score difference of ≥1 point was shown to reflect a clinically significant difference (mean [95% confidence interval] absolute score difference, 0.90 [0.79-1.02] for clinically different image pairs and 0.33 [0.19-0.46] for not clinically different pairs). Intrarater agreement between the 2 validation sessions was substantial (mean weighted kappa = 0.79). Interrater agreement was substantial during the second rating session (0.70, primary end point). CONCLUSION: The Allergan Infraorbital Hollows Scale is a validated and reliable scale for physician rating severity of hollowing in the infraorbital area.


Asunto(s)
Pesos y Medidas Corporales/métodos , Cara/patología , Fotograbar , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Cara/anatomía & histología , Femenino , Humanos , Masculino , Persona de Mediana Edad , Variaciones Dependientes del Observador , Reproducibilidad de los Resultados , Índice de Severidad de la Enfermedad , Adulto Joven , Cigoma
18.
Dermatol Surg ; 42(5): 608-17, 2016 May.
Artículo en Inglés | MEDLINE | ID: mdl-27124878

RESUMEN

BACKGROUND: Eyebrow loss may have substantial negative functional and social consequences. OBJECTIVE: Evaluate the safety and efficacy of bimatoprost 0.03% in subjects with eyebrow hypotrichosis. METHODS: This multicenter, double-masked study randomized adult females or males with eyebrow hypotrichosis to receive bimatoprost 0.03% twice (BID) or once daily (QD) or vehicle BID for 7 months. Primary endpoint was overall eyebrow fullness at Month 7. Secondary endpoints included eyebrow fullness (mm), darkness (intensity units), and subject satisfaction with treatment. Safety was also assessed. RESULTS: At Month 7, the proportion of subjects with improvement was significantly higher in bimatoprost groups versus vehicle (both, p < .001). Improvements occurred in both bimatoprost groups versus vehicle after Month 1 and continued through follow-up; eyebrow fullness and darkness improved as early as Months 2 and 1, respectively (both, p < .001). Greater satisfaction was reported with bimatoprost versus vehicle at Month 2 and all subsequent time points. Overall, 38.1%, 42.4%, and 35.5% of subjects in the bimatoprost BID, QD, and vehicle groups, respectively, experienced ≥1 treatment-emergent adverse event (TEAE). Most frequent TEAEs were similar across groups. No skin or iris hyperpigmentation or conjunctival hyperemia occurred. CONCLUSION: Bimatoprost 0.03% BID and QD is safe, well tolerated, and effective for eyebrow hypotrichosis.


Asunto(s)
Bimatoprost/administración & dosificación , Técnicas Cosméticas , Cejas/efectos de los fármacos , Hipotricosis/tratamiento farmacológico , Adulto , Anciano , Anciano de 80 o más Años , Método Doble Ciego , Femenino , Humanos , Masculino , Persona de Mediana Edad , Satisfacción del Paciente , Resultado del Tratamiento
19.
Dermatol Surg ; 42 Suppl 1: S288-S299, 2016 Nov.
Artículo en Inglés | MEDLINE | ID: mdl-27787269

RESUMEN

BACKGROUND: ATX-101 (deoxycholic acid injection; Kythera Biopharmaceuticals, Inc., Westlake Village, CA [an affiliate of Allergan plc, Dublin, Ireland]) was recently approved for submental fat (SMF) reduction in the United States (Kybella) and Canada (Belkyra). The pivotal trials supporting these approvals revealed that ATX-101 is associated with common injection-site treatment reactions consistent with its mechanism of action and administration procedure. OBJECTIVE: The purpose of this study was to evaluate 4 patient experience management paradigms targeting the common injection-site adverse events of pain, swelling/edema, and bruising after a single treatment session with ATX-101. METHODS: In this double-blind, parallel-group, exploratory Phase 3b study (ClinicalTrials.gov identifier: NCT02007434), subjects with moderate to severe SMF were randomized 4:1 within each paradigm to receive ATX-101 2 mg/cm or placebo. In Paradigm 1, subjects received a cold pack application to the treatment area. In Paradigm 2, in addition to cold pack application, subjects were treated with topical lidocaine and injectable lidocaine containing epinephrine. In Paradigm 3, in addition to the interventions of Paradigm 2, subjects received loratadine and ibuprofen. Subjects in Paradigm 4 received the same interventions in Paradigm 3, plus application of a chin strap. RESULTS: Eighty-three subjects were treated. In ATX-101-treated subjects, peak pain occurred within 1 to 5 minutes of treatment, with median values at these time points ranging from 21.4 to 35.7 mm on a 100-mm pain visual analog scale ("mild"). Pain ratings reduced substantially by 15 minutes; at 4 hours after injection, pain was characterized as mild tenderness or mild achiness. Compared with cold alone, treatment with topical and injectable lidocaine reduced median peak pain by 17%. Addition of ibuprofen and loratadine resulted in a total reduction in pain by 40%. Peak swelling/edema in ATX-101-treated subjects was "modest," with mean values ≤1.7 (on a 0-5 scale) across all paradigms. Swelling/edema was not substantially mitigated by the interventions, including ibuprofen, loratidine, and the use of a chin strap. Bruising associated with ATX-101 treatment was confined to the treatment area, with mean values between 1.0 and 1.4 on a 0-to-5 scale. Bruising was modestly reduced by injectable lidocaine with epinephrine. CONCLUSION: Results from this study support the safety of ATX-101 for SMF reduction, and demonstrate that pain and bruising associated with ATX-101 treatment can be mitigated by a series of simple measures.


Asunto(s)
Ácido Desoxicólico/administración & dosificación , Fármacos Dermatológicos/administración & dosificación , Grasa Subcutánea/efectos de los fármacos , Adulto , Mentón , Contusiones/etiología , Contusiones/terapia , Técnicas Cosméticas/efectos adversos , Ácido Desoxicólico/efectos adversos , Fármacos Dermatológicos/efectos adversos , Método Doble Ciego , Edema/etiología , Edema/terapia , Femenino , Humanos , Inyecciones Subcutáneas/efectos adversos , Masculino , Persona de Mediana Edad , Dolor Postoperatorio/etiología , Dolor Postoperatorio/terapia , Complicaciones Posoperatorias/etiología , Complicaciones Posoperatorias/prevención & control , Complicaciones Posoperatorias/terapia
20.
Dermatol Surg ; 42(10): 1199-1208, 2016 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-27668925

RESUMEN

BACKGROUND: The popularity of aesthetic procedures in the face has led to greater disparity between treated areas and those that still show evidence of true age. Although many areas of the body often require multiple treatment procedures for optimal rejuvenation, combination therapy for specific areas is not yet well defined. OBJECTIVE: To develop recommendations for the optimal combination and ideal sequence of botulinum toxin (BoNT), hyaluronic acid, calcium hydroxylapatite (CaHA), and microfocused ultrasound with visualization in nonfacial areas across all skin phototypes. METHODS: Fifteen specialists convened under the guidance of a certified moderator. Consensus was defined as approval from 75% to 94% of all participants, whereas agreement of ≥95% denoted a strong consensus. RESULTS: Recommendations have been provided for the neck, décolletage, and hands and include the timing and sequence of specific procedures when used concurrently or over several treatment sessions. Position statements are offered in lieu of consensus for the upper arms, abdomen, buttocks, and knees. CONCLUSION: Nonfacial rejuvenation often requires multiple procedures for optimal results in individuals with significant age-related changes. Further clinical studies are recommended to raise awareness of non-facial indications and provide clinicians with the best evidence for best treatment practices.

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