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1.
J Cosmet Dermatol ; 23(7): 2373-2379, 2024 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-38757429

RESUMEN

BACKGROUND: Recent research introduced the concept of the "line of convergence" as a guide for injectors to enhance precision and avoid complications when treating the frontalis muscle with toxins. However, currently, no pre-injection ultrasound scanning is employed to increase precision and reduce adverse events when searching for the line of convergence. OBJECTIVE: To explore the feasibility and practicality of implementing pre-injection ultrasound scanning into aesthetic neuromodulator treatments of the forehead. METHODS: The sample of this study consisted of n = 55 volunteers (42 females and 13 males), with a mean age of 42.24 (10.3) years and a mean BMI of 25.07 (4.0) kg/m2. High-frequency ultrasound imaging was utilized to measure the thickness, length, and contractility of the frontal soft tissue and to determine the precise location of the line of convergence during maximal frontalis muscle contraction. RESULTS: The results revealed that the line of convergence was located at 58.43% (8.7) of the total forehead height above the superior border of the eyebrow cilia without a statistically significant difference between sex, age, or BMI. With frontalis muscle contraction, the forehead shortens in males by 25.90% (6.5), whereas in females it shortens only by 21.74% (5.1), with p < 0.001 for sex differences. CONCLUSION: This study demonstrated the feasibility and practicality of pre-injection ultrasound scanning for facial aesthetic neuromodulator treatments. Knowing the location of the line of convergence, injectors can determine precisely and on an individual basis where to administer the neuromodulator deep or superficial or when the injection location is at risk to cause eyebrow ptosis.


Asunto(s)
Técnicas Cosméticas , Músculos Faciales , Estudios de Factibilidad , Frente , Ultrasonografía , Humanos , Femenino , Masculino , Adulto , Persona de Mediana Edad , Músculos Faciales/diagnóstico por imagen , Músculos Faciales/efectos de los fármacos , Técnicas Cosméticas/efectos adversos , Ultrasonografía/métodos , Contracción Muscular/efectos de los fármacos , Toxinas Botulínicas Tipo A/administración & dosificación , Toxinas Botulínicas Tipo A/efectos adversos , Envejecimiento de la Piel/efectos de los fármacos , Inyecciones Intramusculares/métodos
2.
Aesthet Surg J ; 44(9): 1001-1013, 2024 Aug 20.
Artículo en Inglés | MEDLINE | ID: mdl-38573527

RESUMEN

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.


Asunto(s)
Técnicas Cosméticas , Rellenos Dérmicos , Ácido Hialurónico , Satisfacción del Paciente , Humanos , Ácido Hialurónico/administración & dosificación , Ácido Hialurónico/efectos adversos , Ácido Hialurónico/análogos & derivados , Femenino , Masculino , Persona de Mediana Edad , Adulto , Resultado del Tratamiento , Rellenos Dérmicos/administración & dosificación , Rellenos Dérmicos/efectos adversos , Técnicas Cosméticas/efectos adversos , Anciano , Estética , Adulto Joven , Método Simple Ciego
3.
Aesthet Surg J ; 44(10): 1105-1117, 2024 Sep 16.
Artículo en Inglés | MEDLINE | ID: mdl-38636497

RESUMEN

BACKGROUND: In 2022, the US experienced a significant increase in demand for minimally invasive aesthetic procedures, underscoring its rising acceptance amid an unregulated educational environment for practitioners. The absence of standardized educational pathways and quality control in aesthetic medicine, primarily provided by nonacademic institutions, highlights a critical need for establishing educational standards to ensure practitioner competence and patient safety. OBJECTIVES: The aim of this study was to identify levels of competency for the aesthetic practitioner and necessary achievement milestones during the educational path from novice to expert injector. METHODS: A total of n = 386 international study participants responded to an online questionnaire regarding their experience in aesthetic medicine practice. The questionnaire comprised 58 questions focusing on professional data, the perceived difficulty of injection, and risk for the occurrence of adverse events for specific facial regions in soft tissue filler and toxin injections. RESULTS: Regardless of medical specialty and experience level, averages of 3.85 (1.8) years, 786.4 (2628) filler injections and 549.9 (1543) toxin injections were estimated to progress from novice to advanced injector, while averages of 6.10 (3.7) years, 1842.2 (4793) filler injections, and 1308.5 (3363) toxin injections were estimated to advance from advanced to expert injector. The nose and the perioral region have been ranked as the facial regions where it is most difficult to achieve a perfect aesthetic outcome and with the greatest risk for the occurrence of adverse events for filler and toxin injections, respectively. CONCLUSIONS: In this study we establish an educational framework in aesthetic medicine by defining the progression from novice to competent and expert injector levels, suggesting 4 years of practice and over 790 filler and 550 neuromodulator injections for competence, and at least 6 years with 1840 filler and 1310 neuromodulator injections for expertise. We also identify critical facial regions for targeted treatments by different expertise levels.


Asunto(s)
Competencia Clínica , Técnicas Cosméticas , Humanos , Encuestas y Cuestionarios/estadística & datos numéricos , Técnicas Cosméticas/efectos adversos , Técnicas Cosméticas/normas , Rellenos Dérmicos/administración & dosificación , Rellenos Dérmicos/efectos adversos , Femenino , Estética , Masculino , Cirugía Plástica
4.
J Plast Reconstr Aesthet Surg ; 92: 264-275, 2024 May.
Artículo en Inglés | MEDLINE | ID: mdl-38582052

RESUMEN

BACKGROUND: The increasing number of esthetic procedures emphasizes the need for effective evaluation methods of outcomes. Current practices include the individual practitioners' judgment in conjunction with standardized scales, often relying on the comparison of before and after photographs. This study investigates whether comparative evaluations influence the perception of beauty and aims to enhance the accuracy of esthetic assessments in clinical and research settings. OBJECTIVE: To compare the evaluation of attractiveness and gender characteristics of faces in group-based versus individual ratings. METHODS: A sample of 727 volunteers (average age of 29.5 years) assessed 40 facial photographs (20 male, 20 female) for attractiveness, masculinity, and femininity using a 5-point Likert scale. Each face was digitally edited to display varying ratios in four lip-related proportions: vertical lip position, lip width, upper lip esthetics, and lower lip esthetics. Participants rated these images both in an image series (group-based) and individually. RESULTS: Differences in the perception of the most attractive/masculine/feminine ratios for each lip proportion were found in both the group-based and individual ratings. Group ratings exhibited a significant central tendency bias, with a preference for more average outcomes compared with individual ratings, with an average difference of 0.50 versus 1.00. (p = 0.033) CONCLUSION: A central tendency bias was noted in evaluations of attractiveness, masculinity, and femininity in group-based image presentation, indicating a bias toward more "average" features. Conversely, individual assessments displayed a preference for more pronounced, "non-average" appearances, thereby possibly pointing toward a malleable "intrinsic esthetic blueprint" shaped by comparative context.


Asunto(s)
Belleza , Estética , Cara , Humanos , Femenino , Masculino , Adulto , Cara/anatomía & histología , Fotograbar , Masculinidad , Feminidad , Adulto Joven , Adolescente , Persona de Mediana Edad , Labio/anatomía & histología , Encuestas y Cuestionarios
6.
Aesthet Surg J ; 44(9): 976-986, 2024 Aug 20.
Artículo en Inglés | MEDLINE | ID: mdl-38377391

RESUMEN

BACKGROUND: The infraorbital hollow (IOH) is a concavity that interrupts the smooth transition between the lower eyelid and the cheek, resulting in a fatigued and aged appearance. Injectable fillers may be utilized to correct volume deficit in the under-eye area, restoring a more youthful appearance. OBJECTIVES: The objective was to demonstrate the effectiveness and safety of a cohesive polydensified matrix (CPM) hyaluronic acid (HA) filler with lidocaine (Belotero Balance (+)) for correcting volume deficit in the IOH. METHODS: Eligible patients with a moderate or severe rating on the Merz Infraorbital Hollow Assessment Scale (MIHAS) were randomized 2:1 to treatment or control. Controls remained untreated until Week 8 and were then treated. Touch-up injections were allowed; retreatment was offered only in the treatment group. Effectiveness was evaluated with the MIHAS. Adverse events were recorded over a 76-week period. RESULTS: The estimated average response rate (≥1 point MIHAS improvement) was 80.6% (95% CI, 71.4-87.4) in treated patients and 1.9% (95% CI, 0.3-10.2) in controls at Week 8. The difference in estimated response rates was 78.7% (95% CI, 66.3-85.6), demonstrating a statistically significant, superior response rate in treated patients compared to untreated controls. A total of 88 of 97 (90.7%) patients who responded to treatment at Week 8 retained improvement 48 weeks after treatment. Use of Belotero Balance (+) in the IOH had a favorable safety profile, with no unexpected adverse events reported. CONCLUSIONS: Belotero Balance (+) is a safe and effective treatment for correcting volume deficit in the IOH.


Asunto(s)
Anestésicos Locales , Técnicas Cosméticas , Rellenos Dérmicos , Ácido Hialurónico , Lidocaína , Humanos , Ácido Hialurónico/administración & dosificación , Ácido Hialurónico/efectos adversos , Lidocaína/administración & dosificación , Lidocaína/efectos adversos , Femenino , Estudios Prospectivos , Persona de Mediana Edad , Masculino , Adulto , Rellenos Dérmicos/administración & dosificación , Rellenos Dérmicos/efectos adversos , Técnicas Cosméticas/efectos adversos , Resultado del Tratamiento , Anestésicos Locales/administración & dosificación , Anciano , Envejecimiento de la Piel/efectos de los fármacos , Párpados/efectos de los fármacos , Factores de Tiempo , Método Simple Ciego , Mejilla
7.
Clin Dermatol ; 42(4): 360-372, 2024.
Artículo en Inglés | MEDLINE | ID: mdl-38336142

RESUMEN

Growth in the research, innovation, and development of laser and energy-based technologies over the past few decades has led to dramatic increases in treatment options for dermatologic and cosmetic concerns of the periorbital area. We highlight recent treatment options using laser and energy-based devices for the clearance of periocular pigmented lesions, including solar lentigines and nevus of Ota; vascular lesions, including port-wine birthmarks, infantile hemangiomas, superficial telangiectasias, and reticular veins; laser ablation of benign tumors, such as xanthelasma; cosmetic rejuvenation; treatment of infraorbital dark circles and festoons; laser removal of eyebrow and eyeliner tattoos; and device-based treatment of chronic dry eyes.


Asunto(s)
Terapia por Láser , Humanos , Rejuvenecimiento , Tatuaje , Técnicas Cosméticas/instrumentación , Neoplasias Cutáneas/terapia , Neoplasias Cutáneas/cirugía , Lentigo/terapia , Telangiectasia/terapia , Hemangioma/terapia
8.
Lasers Surg Med ; 56(1): 32-38, 2024 Jan.
Artículo en Inglés | MEDLINE | ID: mdl-37694399

RESUMEN

BACKGROUND: A recent study showed the safety and efficacy of a noninvasive acoustic subcision device to improve the appearance of cellulite via delivery of rapid acoustic pulses in a single treatment visit. OBJECTIVE: To evaluate and compare the safety and efficacy of a single rapid acoustic pulse treatment visit using an equivalent number of rapid acoustic pulses at a pulse rate of 100 or 50 Hz. METHODS: This single-center, prospective study enrolled 15 adult women with moderate to severe cellulite according to the Cellulite Dimple-At Rest Scale. Each participant would receive nominally 72,000 rapid acoustic pulses at a pulse rate of 50 Hz on the left buttock and thigh, and nominally 72,000 rapid acoustic pulses at a pulse rate of 100 Hz on the right buttock and thigh within one treatment visit. Efficacy was assessed by the ability of blinded, independent reviewers to correctly distinguish the pre- and post-treatment photos, participant satisfaction, and the change in Cellulite Dimple-At Rest scores for each treatment side. Safety was monitored throughout the conduct of the study. RESULTS: For both 100 and 50 Hz pulse rate treated areas, the majority (two out of three) of blinded reviewers correctly identified 100% of the pre/post-treatment photos. For both the 100 and 50 Hz treated areas, 80% of participants agreed/strongly agreed that their cellulite appeared improved at the 12-week follow-up visit. Significant improvements in Cellulite Dimple-At Rest scores were seen for both the 100 and 50 Hz treated areas. All participants thought both the 100 and 50 Hz pulse rate treatments were tolerable, and the pain (mean score ± SD; 2.2 ± 1.2) associated with each was identical. No unexpected or serious adverse events occurred. CONCLUSION: Acoustic subcision delivered via rapid acoustic pulses at 100 Hz, compared to 50 Hz, provides equivalent improvement in the appearance of cellulite while maintaining a similar safety and efficacy profile. For both pulse rates, treatment pain was minimal, and participant satisfaction was high.


Asunto(s)
Celulitis , Técnicas Cosméticas , Adulto , Humanos , Femenino , Frecuencia Cardíaca , Celulitis/diagnóstico , Celulitis/terapia , Estudios Prospectivos , Muslo , Dolor , Resultado del Tratamiento
9.
J Cosmet Dermatol ; 22(7): 2063-2070, 2023 Jul.
Artículo en Inglés | MEDLINE | ID: mdl-36852750

RESUMEN

BACKGROUND: Due to the great importance of the face in social interaction, minimally invasive treatments can-besides their ability to rejuvenate and enhance beauty-also change the way facial impressions of a person are perceived. In recent literature, three main character traits (attractiveness, trustworthiness, and competence) and subdomains essential for facial perception were described. OBJECTIVE: To investigate whether minimally invasive procedures truly influence different character traits when evaluated by independent, objective observers. METHODS: Photographs of n = 34 female faces before and after treatment with injectable fillers and botulinum toxin were rated by 393 individuals without aesthetic background with regards to different character traits on a 7-point Likert scale. Tests for dimensionality were performed, and composite scores of the impressions underlying each of the three dimensions were created and compared using within-subjects t tests. RESULTS: Treatments statistically significantly improved the overarching character trait domains attractiveness, trustworthiness, and competence in posttreatment photographs compared with pretreatment. Posttreatment ratings of the respective subdomains also showed a statistically significant difference compared with pretreatment photographs, with the exception of the subdomain dominance which failed to reach statistical significance. CONCLUSION: Impressions of facial attractiveness, trustworthiness, and competence can be improved by injectables while the naturalness of the face is left intact. An implication is that the improvement of traits highly relevant to social interaction will accommodate the patient's desires for beautification and rejuvenation.


Asunto(s)
Actitud , Belleza , Humanos , Femenino , Estética , Rejuvenecimiento
10.
Aesthet Surg J ; 43(Suppl 1): S1-S9, 2023 11 09.
Artículo en Inglés | MEDLINE | ID: mdl-36095026

RESUMEN

BACKGROUND: Botulinum toxin type A (BoNTA) injections for the treatment of facial lines may lead to pleasant or undesirable changes in eyebrow height and position. OBJECTIVES: The aim of this study was to evaluate the impact of glabellar injection of DaxibotulinumtoxinA for Injection (DAXI), a novel BoNTA formulation, on eyebrow position and frontalis activity. METHODS: This study involved the post hoc analysis of adult patients from the Phase 2a forehead lines (FHL, N = 60) and open-label safety (OLS, N = 175) studies who received a single dose of DAXI 40 U to the glabella and for whom facial photographs were taken at rest and at maximum eyebrow elevation. Median vertical and horizontal displacement of the brows and median forehead strain (an objective quantitative assessment of frontalis activity) from baseline to 2 weeks after glabellar DAXI injection were measured. RESULTS: Two weeks after glabellar DAXI injection, vertical eyebrow movement (at rest) of the lateral brow was observed. In both studies, vertical movement was greatest in the lateral (0.6-0.9 mm) and mid (0.5-0.7 mm) brow regions; movement in the medial brow was negligible (0-0.23 mm). In both studies, a graded reduction in forehead strain was observed 2 weeks post glabellar DAXI injection, with the greatest reduction being in the lower segment (FHL, -73%; OLS, -82%). Treatment with DAXI showed improvements in FHL wrinkle severity. CONCLUSIONS: Glabellar injection of DAXI showed a positive reduction in dynamic frontalis activity that maintained or had a positive effect on eyebrow position. Vertical movement of the brow was suggestive of an improved eyebrow shape with a mild lateral arch.


Asunto(s)
Toxinas Botulínicas Tipo A , Fármacos Neuromusculares , Envejecimiento de la Piel , Adulto , Humanos , Frente , Inyecciones , Músculos , Fármacos Neuromusculares/efectos adversos , Ensayos Clínicos Fase II como Asunto
11.
Plast Reconstr Surg Glob Open ; 10(10): e4547, 2022 Oct.
Artículo en Inglés | MEDLINE | ID: mdl-36262685

RESUMEN

Micro-coring technology (MCT) removes cores of skin without formation of scars, thereby tightening skin and reducing skin wrinkling. The purpose of this study was to evaluate the safety and efficacy of MCT with the dermal micro-coring device for the treatment of facial wrinkles. Methods: This prospective, multicenter clinical trial included fifty-one subjects who underwent MCT treatments of the mid to lower face. The primary study endpoint was change in the Lemperle Wrinkle Severity Scale. Secondary study endpoints were change in Global Aesthetic Improvement Scale (GAIS), participant satisfaction, and evaluation of treatment outcome by an independent review panel. All study endpoints were evaluated at 1, 7, 30, 60, and 150 or 180 days after treatment. Procedure bleeding, pain, and early healing profile were also captured. Results: The mean Lemperle Wrinkle Severity Scale change was 1.3 grades. Improvement in the GAIS was reported for 89.7% (87/97) of treated sites, and average improvement of GAIS was 1.5. Participants reported satisfaction with 85.6% of treatment sites. The independent review panel correctly identified 84.2% of the post-treatment photographs as post-treatment. Procedure bleeding and pain was mild with good healing responses and patient-reported average down time of 3 days. Conclusions: The results of this study demonstrate the safety and efficacy of MCT with the dermal micro-coring device for the treatment of moderate to severe facial wrinkles. MCT led to significant improvement of facial wrinkles with high patient satisfaction and fast recovery time and should be considered in patients who are seeking minimally invasive treatment for wrinkles of the face.

14.
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
15.
Plast Reconstr Surg ; 145(1): 45-58, 2020 01.
Artículo en Inglés | MEDLINE | ID: mdl-31609882

RESUMEN

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.


Asunto(s)
Toxinas Botulínicas Tipo A/farmacología , Inyecciones , Fármacos Neuromusculares/farmacología , Envejecimiento de la Piel/efectos de los fármacos , Adulto , Toxinas Botulínicas Tipo A/administración & dosificación , Método Doble Ciego , Femenino , Frente , Humanos , Masculino , Persona de Mediana Edad , Fármacos Neuromusculares/administración & dosificación , Adulto Joven
16.
Dermatol Surg ; 45(12): 1570-1579, 2019 12.
Artículo en Inglés | MEDLINE | ID: mdl-30807389

RESUMEN

BACKGROUND: Microneedling and soft-tissue filler injections have been used independently to improve acne scarring. The effectiveness of a combined approach using microneedling followed by polymethylmethacrylate (PMMA)-collagen gel has not been carefully studied. OBJECTIVE: The goal of this study was to assess the effectiveness and safety of microneedling alone versus microneedling followed by injection of PMMA-collagen gel filler for correction of atrophic facial acne scars. METHODS: We conducted a multicenter, open-label, randomized, prospective study on subjects with distensible atrophic acne scars in the face to determine whether microneedling with PMMA-collagen gel is a superior acne scar treatment over microneedling alone. Forty-four subjects received 3 microneedling treatments over a 12-week period followed by randomization to treatments with PMMA-collagen gel (treatment group) or no further treatment (control group). RESULTS: At 24 weeks, the treatment group achieved a statistically significant improvement in acne scores over microneedling alone. The improvement continued at 36 weeks. At 24 weeks, the treatment group showed a strong trend in improvement on the Physician Global Aesthetic Improvement Scale compared with microneedling alone.


Asunto(s)
Cicatriz/terapia , Colágeno/administración & dosificación , Rellenos Dérmicos/administración & dosificación , Agujas , Polimetil Metacrilato/administración & dosificación , Acné Vulgar/complicaciones , Adulto , Anciano , Atrofia/diagnóstico , Atrofia/etiología , Atrofia/terapia , Cicatriz/diagnóstico , Cicatriz/etiología , Colágeno/efectos adversos , Terapia Combinada/efectos adversos , Terapia Combinada/métodos , Rellenos Dérmicos/efectos adversos , Cara , Femenino , Humanos , Inyecciones Intralesiones , Masculino , Persona de Mediana Edad , Proyectos Piloto , Polimetil Metacrilato/efectos adversos , Estudios Prospectivos , Índice de Severidad de la Enfermedad , Resultado del Tratamiento , Adulto Joven
18.
Aesthet Surg J ; 39(4): 413-422, 2019 03 14.
Artículo en Inglés | MEDLINE | ID: mdl-29506034

RESUMEN

BACKGROUND: VYC-15L (Juvéderm Volbella XC) is a nonanimal crosslinked hyaluronic acid (HA) gel with lidocaine. OBJECTIVES: To evaluate safety and effectiveness of repeat treatment with VYC-15L administered 1 year after treatment for lip and perioral enhancement. METHODS: In this prospective multicenter study, 124 subjects with minimal, mild, or moderate lip fullness on the validated 5-point Allergan Lip Fullness Scale (LFS) who received initial/touch-up treatment with VYC-15L received repeat treatment with VYC-15L 1 year after initial treatment. Effectiveness endpoints included LFS responder rates (≥1-point improvement from baseline) and scores on the FACE-Q Satisfaction With Lips and Appraisal of Lip Lines scales at 1 month after repeat treatment. Subjects completed safety diaries for 30 days after repeat treatment. RESULTS: LFS responder rates were 86.2%, 80.3%, and 65.3% at months 1 and 3 and 1 year, respectively, after initial/touch-up treatment. The responder rate improved to 94.3% 1 month after repeat treatment with VYC-15L and required less median volume vs initial/touch-up treatment (1.5 vs 2.6 mL). FACE-Q scores doubled from baseline at 3 months, remained high through 1 year, and doubled from baseline after repeat treatment. At 1 month after repeat treatment, 96.7% and 89.3% of subjects showed improvement over baseline in FACE-Q Satisfaction With Lips and Appraisal of Lip Lines, respectively. Severe injection site responses were less frequent after repeat treatment than initial/touch-up treatment. CONCLUSIONS: Repeat treatment with VYC-15L at 1 year was safe and effective for lip and perioral enhancement, and required less product volume to achieve similar effectiveness to initial/touch-up treatment.


Asunto(s)
Técnicas Cosméticas , Rellenos Dérmicos/administración & dosificación , Ácido Hialurónico/administración & dosificación , Labio , Adulto , Anciano , Técnicas Cosméticas/efectos adversos , Rellenos Dérmicos/efectos adversos , Femenino , Estudios de Seguimiento , Humanos , Lidocaína/administración & dosificación , Masculino , Persona de Mediana Edad , Satisfacción del Paciente , Estudios Prospectivos , Adulto Joven
20.
Lasers Surg Med ; 49(4): 335-340, 2017 04.
Artículo en Inglés | MEDLINE | ID: mdl-28319270

RESUMEN

BACKGROUND AND OBJECTIVE: Laser-assisted treatment of tattoos is well recognized to produce opaque epidermal whitening that prevents multiple sequential passes during a single treatment session. The amount of epidermal whitening produced in association with the procedure can be minimized by topical application of perfluorodecalin (PFD), which is an optical clearing agent. This pivotal trial assessed the ability of a transparent PFD-infused patch used in conjunction with a Q-switched nanosecond laser in the treatment of tattoos to permit multiple laser passes during a single 5 minute treatment session in comparison to the number of passes that could be completed using conventional treatment of the tattoo with the laser alone. STUDY DESIGN: Thirty subjects (mean age 37 years; 14 males) with predominantly dark blue or black tattoos were enrolled in a split-tattoo trial. One half of each tattoo was treated conventionally, whereas the other half was treated through the PFD patch. Treatments were performed using a nanosecond Q-switched 755-nm Alexandrite laser. The number of treatments performed in a 5-minute time period was quantified for each side of the tattoo (primary effectiveness outcome). Patient-reported pain scores and adverse events (AEs) were also evaluated. RESULTS: Significantly more laser passes could be made on average using the PFD patch compared with treatment using the laser alone (3.7 passes vs. 1.4 passes; P < 0.001). AEs were limited to those expected during laser removal of tattoos. The proportions of subjects with transient edema and erythema were lower in the PFD patch treatment group (36.7% vs. 63.3% and 33.3% vs. 70.0%, respectively); all AEs were transient and resolved quickly. No patient in either group exhibited dyschromia (hypo- or hyperpigmentation) in the treatment area at the 1-month post treatment visit. Additionally, when surveyed at the 1-month follow-up visit, all subjects (30/30) preferred to continue laser-assisted tattoo removal with the PFD patch. CONCLUSION: An average of 3.7 laser passes were made in a defined 5-minute treatment session when using the transparent PFD-infused patch, which is significantly more than was possible with the laser alone (average of 1.4 passes). Use of the PFD patch was associated with improved tolerability compared with conventional treatment, with subjects experiencing fewer and less severe AEs related to epidermal injury. Lasers Surg. Med. 49:335-340, 2017. © 2017 Wiley Periodicals, Inc.


Asunto(s)
Fluorocarburos/administración & dosificación , Terapia por Láser/métodos , Láseres de Estado Sólido/uso terapéutico , Tatuaje , Administración Cutánea , Adulto , Epidermis/efectos de la radiación , Femenino , Humanos , Terapia por Láser/efectos adversos , Masculino , Persona de Mediana Edad , Dispersión de Radiación , Parche Transdérmico , Adulto Joven
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