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2.
Plast Reconstr Surg Glob Open ; 11(9): e5287, 2023 Sep.
Artigo em Inglês | MEDLINE | ID: mdl-37744770

RESUMO

Background: The objective of this investigation was to create and validate five-point photonumeric scales which assess static and dynamic forehead lines. Methods: Two different novel five-point photonumeric scales for the assessment of static and dynamic forehead lines were developed. Moreover, a photoguide was created, including subjects from both sexes, all age groups, and different Fitzpatrick skin types. A total of 11 raters from all over the world were involved in the digital validation, whereas four raters performed a live validation. Results: The Croma Static Forehead Lines-Assessment Scale showed almost perfect inter and intra-rater agreement in both the digital and the live setting with inter-rater intraclass correlation coefficients of 0.86 [95% confidence interval (CI): 0.82-0.89] in the first digital rating and 0.82 [95% CI: 0.78-0.86] in the second digital rating. The Croma Dynamic Forehead Lines-Assessment Scale showed almost perfect inter and intra-rater agreement in the digital setting with inter-rater intraclass correlation coefficients of 0.83 [95% CI: 0.79-0.86] in the first digital rating and 0.80 [95% CI: 0.75-0.84] in the second rating and almost substantial agreement in the live setting. Conclusions: The Croma Static Forehead Lines-Assessment Scale and the Croma Dynamic Forehead Lines-Assessment Scale have excellent inter and intra-rater agreements to be justifiably used in the clinical and study setting, both digitally and live across ethnic groups.

3.
Aesthet Surg J ; 43(11): 1347-1356, 2023 10 13.
Artigo em Inglês | MEDLINE | ID: mdl-37052953

RESUMO

BACKGROUND: The use of validated scales is still considered the gold standard for evaluating the severity of an aesthetic facial condition. OBJECTIVES: The aim of this investigation was to create and validate 5-point photonumeric scales for the assessment of perioral lines and marionette lines. METHODS: A medical team created 2 different novel 5-point photonumeric scales for the assessment of perioral lines and marionette lines. Eleven international raters were involved in the digital validation, and 4 raters performed a live validation. RESULTS: For the Croma Static Perioral Lines-Assessment Scale, the digital interrater intraclass correlation coefficients (ICCs) were 0.88 (95% CI, 0.85-0.91) in the first rating and 0.87 (95% CI, 0.83-0.90) in the second rating. The digital intrarater ICCs were 0.90 (95% CI, 0.87-0.92). In the live rating, the interrater ICCs were 0.89 (95% CI, 0.85-0.93) in the first rating and 0.91 (95% CI, 0.87-0.93) in the second rating with an intrarater ICC of 0.91 (95% CI, 0.88-0.95). For the Croma Marionette Lines-Assessment Scale, the digital rating interrater ICCs were 0.85 (95% CI, 0.81-0.89) in the first rating and 0.87 (95% CI, 0.84-0.90) in the second rating with an intrarater ICC of 0.89 (95% CI, 0.88-0.91). In the live rating, the interrater ICCs were 0.73 (95% CI, 0.54-0.83) in the first rating and 0.79 (95% CI, 0.65-0.87) in the second rating with an intrarater ICC of 0.88 (95% CI, 0.83-0.94). CONCLUSIONS: The Croma Static Perioral Lines-Assessment Scale and the Croma Marionette Lines-Assessment Scale have exceptional inter- and intrarater agreements that justify their use in clinical and study settings for all ethnic groups.


Assuntos
Face , Fotografação , Humanos , Reprodutibilidade dos Testes , Estética , Variações Dependentes do Observador
4.
Aesthet Surg J ; 43(7): NP560-NP572, 2023 06 14.
Artigo em Inglês | MEDLINE | ID: mdl-36840504

RESUMO

BACKGROUND: There is a scarcity of scales that assess platysmal bands, wrinkles in the décolleté, and horizontal neck lines in the digital and live setting. OBJECTIVES: The objective of this investigation was to create and validate 5-point photonumeric scales that assess horizontal neck lines, platysmal bands, and wrinkles in the décolleté. METHODS: A medical team created 3 different novel 5-point photonumeric scales for the assessment of horizontal neck lines, platysmal bands, and décolleté wrinkling. Eleven international raters were involved in the digital validation, and 4 raters performed a live validation. RESULTS: The Croma (Leobendorf, Austria) Horizontal Neck Lines Assessment Scale showed substantial interrater agreement and almost perfect intrarater agreement in the digital and live validations, respectively. The Croma Platysmal Bands Assessment Scale showed substantial intrarater agreement in both digital and live validations. For the décolleté, a static scale and a dynamic scale were created and validated. The Croma Static Décolleté Wrinkles Assessment Scale showed substantial and almost perfect interrater agreement in the digital and live validations, respectively, and the intrarater agreement in both was almost perfect. The Croma Dynamic Décolleté Wrinkles Assessment Scale showed almost perfect agreement in both validation settings for both interrater and intrarater measures. CONCLUSIONS: The Croma Horizontal Neck Lines Assessment Scale and the Croma Static and Dynamic Décolleté Wrinkles Assessment Scales have sufficient interrater and intrarater agreement for justifiable use in clinical and research settings.


Assuntos
Envelhecimento da Pele , Humanos , Reprodutibilidade dos Testes , Pescoço , Variações Dependentes do Observador
6.
Clin Cosmet Investig Dermatol ; 15: 1213-1223, 2022.
Artigo em Inglês | MEDLINE | ID: mdl-35800454

RESUMO

Complications such as delayed inflammatory reactions (DIRs) and unnatural outcomes can sometimes arise from hyaluronic acid (HA) dermal filler treatments and can be challenging to address. Given the popularity of HA dermal fillers for aesthetic procedures, there is a need for preventive strategies to minimize these complications. Two hundred practitioners from 10 regions in Asia Pacific who administer HA fillers completed a survey on prevention of DIRs and unnatural outcomes. Thirteen global experts convened to evaluate the current practices and propose practical approaches for safe and appropriate use of HA dermal fillers. From the survey, the top three measures used to reduce the risk of DIRs included choosing an appropriate HA filler, aseptic technique, and patient selection. Key strategies employed to achieve natural-looking outcomes were treatment customization, understanding the rheological properties and behavior of different HA fillers, and being conservative in treatment approach. The panel developed a concise reference guide aimed at minimizing the risk of DIRs while achieving natural aesthetic outcomes. Five practical considerations were recommended: patient assessment and individualization of treatment plan, choice of an appropriate HA filler, adequate knowledge of facial anatomy, strict adherence to aseptic methods, and proper injection technique. The panel highlighted the need for education efforts to increase awareness of differential immunogenicity between HA fillers and to improve understanding on the importance of preserving aesthetic individuality for optimal results. These practical insights from the global experts support practitioners in optimizing safety and quality of aesthetic treatment with HA fillers.

7.
Facial Plast Surg Clin North Am ; 30(2): 225-231, 2022 May.
Artigo em Inglês | MEDLINE | ID: mdl-35501060

RESUMO

Neuromodulator treatments limit the contractility of the frontalis muscle, resulting in reduced dynamic and static horizontal forehead line formation of the overlying skin. This interventional study investigated the electrophysiologic response (via signal-to-noise [SNR] ratio) and the overlying skin displacement of the frontalis muscle following neuromodulator injections in a total of 11 healthy neuromodulator-naïve volunteers. Relating SNR to the respective skin movement revealed that the higher the SNR, the more vertical the skin displacement is; this remained statistically relevant after gender stratification. These results are novel and will help the aesthetic community to understand neuromodulator effects on the frontalis muscle.


Assuntos
Testa , Músculo Esquelético , Estética , Humanos , Injeções , Neurotransmissores/farmacologia
8.
J Drugs Dermatol ; 21(5): 481-487, 2022 May 01.
Artigo em Inglês | MEDLINE | ID: mdl-35533030

RESUMO

BACKGROUND: Soft tissue augmentation with calcium hydroxylapatite (CaHA) is a versatile technique for line filling, skin tightening, lifting, contouring, and volumizing. The present study was designed to confirm safety and effectiveness of the product with lidocaine (CaHA (+)) in a holistic treatment of nasolabial folds (NLFs), marionette lines, and/or cheeks. METHODS: A total of 207 subjects with moderate to severe facial volume deficit were treated with CaHA(+) in this open-label study. Effectiveness assessments included Merz Aesthetics Scales® (MAS), investigator- and subject-assessed Global Aesthetic Improvement Scales (iGAIS/sGAIS), and FACE-QTM questionnaires. Responder rates were defined as at least one-point improvement on MAS according to blinded rating. Safety was assessed through adverse event reporting. RESULTS: Primary endpoint was evaluated 12 weeks after last injection. Responder rates were 93.6%, 88.7%, and 81.9% in the NLFs, marionette lines, and cheeks, respectively, and were statistically significant above the pre-defined 60% threshold (P< 0.0001). Investigator- and subject-assessed GAIS were consistent and showed high rates of improvement throughout the study, with peak values of 98.0% at week 4 on iGAIS and 93.5% at 12 weeks after last injection on sGAIS. After 18 months, the majority of subjects (52.5%) still perceived improvement via sGAIS. Moreover, total FACE-Q scores demonstrated high subject satisfaction with treatment. All related treatment emergent adverse events were transient and expected injection-site reactions mostly of mild to moderate intensity. CONCLUSION: CaHA (+) has demonstrated safety and effectiveness in the treatment of NLFs, marionette lines, and cheek volume loss in real-life conditions up to 18 months. J Drugs Dermatol. 2022;21(5):481-487. doi:10.36849/JDD.6737.


Assuntos
Técnicas Cosméticas , Preenchedores Dérmicos , Envelhecimento da Pele , Cálcio , Técnicas Cosméticas/efeitos adversos , Preenchedores Dérmicos/efeitos adversos , Durapatita/efeitos adversos , Humanos , Ácido Hialurônico , Lidocaína/efeitos adversos , Sulco Nasogeniano , Resultado do Tratamento
9.
J Cosmet Dermatol ; 21(3): 933-939, 2022 Mar.
Artigo em Inglês | MEDLINE | ID: mdl-35034418

RESUMO

OBJECTIVE: Quantifying the degree of dorsal hand atrophy is a challenging endeavor, but often necessary, in both the clinical and the research setting. The aim of this investigation was to create and consecutively validate a 5-point photonumeric scale for assessment of dorsal hand atrophy. MATERIAL AND METHODS: A medical team created a novel 5-point photonumeric scale. Twelve international raters were involved in the digital validation, while five raters performed a live validation. RESULTS: For the digital validation of the Croma Hand Atrophy Assessment Scale, a total of 72 subjects (58 females, 14 males) with a mean age of 43.0 ± 14.4 years [18-73 years] were assessed. For the live validation, 88 subjects (73 females, 15 males) with a mean age of 45.0 ± 14.1 years [20-73 years] were rated. The results revealed almost perfect intra-rater (ICC: 0.90 [95% CI: 0.88-0.92]) and inter-rater agreements (ICC: 0.85 [95% CI: 0.81-0.89] and 0.86 [95% CI:0.82-0.89]) in the digital validation and substantial intra-rater (ICC: 0.79 [95% CI: 0.75-0.82]) and inter-rater agreements (ICC: 0.75 [95% CI: 0.68-0.81] and ICC: 0.67 [95% CI: 0.54-0.77]) in the live validation. CONCLUSION: The created scale to assess dorsal hand atrophy has been shown to provide substantial-to-almost perfect agreement in the digital and live validation cycles and reached comparable intra-rater and inter-rater agreement to already published and validated scales. It is expected that the created scale will help physicians and researchers in the assessment of hand atrophy in the clinical and research setting in the future.


Assuntos
Reprodutibilidade dos Testes , Adulto , Atrofia , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Variações Dependentes do Observador
10.
J Cosmet Dermatol ; 21(2): 636-647, 2022 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-34951735

RESUMO

BACKGROUND: Microfocused ultrasound with visualization (MFU-V; Ultherapy® , Merz North America) is US Food and Drug Administration-cleared as a non-invasive procedure that lifts the soft tissue of the neck, submentum and brow, and improves lines and wrinkles on the upper chest. Several other energy-based devices are in use in countries outside the USA where they are marketed for indications similar to those of MFU-V, although published studies supporting these indications are limited and none of the other devices provides visualization or verification they reach the superficial musculoaponeurotic system. METHODS: Due to the evolving landscape of ultrasound technology as more devices enter the market, seven global thought leaders who are qualified experts on the use of various high-intensity focused ultrasound (HIFU)/MFU-V technologies convened to review data from an independent evaluation of the software, thermal characteristics, transducer acoustics and ultrasound therapy of MFU-V and three other ultrasound-based devices. RESULTS: The independent testing demonstrated the devices have key differences in several parameters that play a role in safety and effectiveness. Specifically, MFU-V has visualization capability but the other devices lack that feature. Other differences include the retention of patient history, consistent size and uniformity of thermal coagulation points (TCPs), precise localization of energy concentration at the focal point, and reliable thermal regulation during use. The expert panel established a consensus on the types of preventable complications associated with ultrasound-based energy devices and techniques for preventing and treating complications. CONCLUSIONS: The independent test results of MFU-V/HIFU devices and the consensus panel conclusions provide strong support that real-time visualization and the capability to detect coupling, features found only in MFU-V, help prevent complications and enhance the safety and effectiveness of energy-based devices. The independent evaluation also revealed that MFU-V has several additional features that play key roles in safety and clinical effectiveness, including uniformity of TCPs, tight thermal regulation, large focal gain, and short beam length, that were not found collectively in any of the HIFU devices.


Assuntos
Envelhecimento da Pele , Terapia por Ultrassom , Consenso , Humanos , Satisfação do Paciente , Ultrassonografia
11.
J Cosmet Dermatol ; 21(1): 158-166, 2022 Jan.
Artigo em Inglês | MEDLINE | ID: mdl-34865301

RESUMO

OBJECTIVE: The objective of this investigation was to create and validate 5-point photonumeric scales for the assessment of dynamic crow's feet, static crow's feet, and infraorbital hollows. MATERIAL AND METHODS: Three novel 5-point photonumeric scales were created by a medical team. A total of 12 raters from all over the world performed a digital validation, and a total of 5 raters a live validation of the created scale. RESULTS: The statistical analysis revealed almost perfect intra-rater and inter-rater reliability in the digital validation of the scales for the assessment of static and dynamic crow's feet as well as infraorbital hollows. In the live validation, both crow's feet scales showed almost perfect intra-rater reliability, while the Croma Infraorbital Hollow Assessment Scale showed substantial intra-rater reliability. Inter-rater reliability was substantial for all three scales in the live validation. All three scales, the Croma Dynamic Crow's Feet Assessment Scale, Croma Static Crow's Feet Assessment Scale, and Croma Infraorbital Hollow Assessment Scale, were validated digitally and in a live setting. CONCLUSION: The created scales to assess infraorbital hollowing, dynamic and static crow's feet have been shown to provide substantial to almost perfect agreement in the digital and live validation and can thus be considered as helpful tools in the clinical and research setting. While technical methods and appliances to assess the degrees of severity of age-dependent features are advancing, validated scales are of great importance due to their ease of use and, as shown by the validations, reliability, and reproducibility.


Assuntos
Envelhecimento da Pele , Face , Humanos , Reprodutibilidade dos Testes
13.
J Cosmet Dermatol ; 21(2): 600-607, 2022 Feb.
Artigo em Inglês | MEDLINE | ID: mdl-34902199

RESUMO

OBJECTIVE: The objective of this investigation was to create and to examine the reproducibility and validity of 5-point photonumeric assessment scales that allow objective assessment of chin retrusion and jawline sagging using a digital and a live validation. MATERIAL AND METHODS: Two new 5-point photonumeric scales created to assess chin projection and jawline sagging were validated by 12 experts in a digital validation and by 5 experts in a live validation setting. Intra-rater agreement and inter-rater agreement were assessed. RESULTS: For the digital validation, an almost perfect intra-rater (Kappa: 0.89 [95% CI: 0.86-0.91]) and almost perfect inter-rater agreement in both sessions (Kappa: 0.80 [95% CI: 0.74-0.86] and 0.80 [95% CI: 0.74-0.86]) was achieved for the Croma Chin Projection Assessment Scale, while intra-rater agreement (Kappa: 0.88 [95% CI: 0.85-0.91]) was almost perfect for the Croma Jawline Sagging Assessment Scale and inter-rater agreement being substantial in the first session (Kappa: 0.76 [95% CI: 0.71-0.81]) and almost perfect in the second session (Kappa: 0.81 [95%CI: 0.76-0.85]). For the live validation, intra-rater agreement was almost perfect for the Croma Chin Projection Assessment Scale (Kappa: 0.82 [95%CI: 0.74-0.90]) and the Croma Jawline Sagging Assessment Scale (Kappa: 0.83 [95%CI: 0.77-0.89]), while inter-rater agreement was substantial in both sessions for both scales. CONCLUSION: The created chin and jawline photonumeric grading scales are valid and reliable tools for assessing chin projection and jawline sagging. The scales will be of value for standardized chin evaluation and quantifying outcomes in clinical research and daily practice.


Assuntos
Fotografação , Queixo , Humanos , Variações Dependentes do Observador , Reprodutibilidade dos Testes
14.
Clin Cosmet Investig Dermatol ; 14: 1175-1199, 2021.
Artigo em Inglês | MEDLINE | ID: mdl-34526796

RESUMO

BACKGROUND: As the treatment indications for the Cohesive Polydensified Matrix® hyaluronic acid (CPM-HA) portfolio continue to expand and diversify, injectors new to the range or those who are expanding the treatments they offer may be unsure of the optimal product and injection technique for specific facial areas. Each product in the CPM-HA portfolio has been intentionally designed to provide the best physical properties for a specific indication and target tissue. This document has been developed to provide a comprehensive, one-stop reference for clinicians using the portfolio. METHODS: An international panel of experts in the field of aesthetic medicine convened to develop guidelines on effective and safe injection technique when performing treatments with the CPM-HA range of soft-tissue fillers. RESULTS: Consensus members considered treatment indications in the upper, middle and lower face. Landmark deficiencies and anatomical considerations are described for each indication and consensus recommendations provided on the optimal product, injection depth and treatment technique. This is supplemented by the experts advice on avoidance of complications. Throughout, an evidence-based approach to selection of products and injection techniques is provided. The result is a fully tailored approach to a range of indications covering the full portfolio of CPM-HA products, including the newest addition for skin revitalization. CONCLUSION: The recommendations in this consensus document are provided to assist clinicians in the selection of CPM-HA products, administration techniques and depths of injection with the aim of providing seamless and natural treatment results, enhanced safety and patient satisfaction.

15.
Plast Reconstr Surg ; 148(2): 320-331, 2021 Aug 01.
Artigo em Inglês | MEDLINE | ID: mdl-34398083

RESUMO

BACKGROUND: The number of soft-tissue filler injections performed in the United States is constantly increasing and reflects the high demand for enhanced facial and body attractiveness. The objective of the present study was to measure the viscoelastic properties of soft-tissue fillers when subjected to different testing frequencies. The range of tested frequencies represents clinically different facial areas with more [lips (high frequency)] or less [zygomatic arch (low frequency)] soft-tissue movement. METHODS: A total of 35 randomly selected hyaluronic acid-based dermal filler products were tested in an independent laboratory for their values of G', G″, tan δ, and G* at angular frequencies between 0.1 and 100 radian/second. RESULTS: The results of the objective analyses revealed that the viscoelastic properties of all tested products changed between 0.1 and 100 radian/second angular frequency. Changes in G' ranged from 48.5 to 3116 percent, representing an increase in their initial elastic modulus, whereas changes in G″ ranged from -53.3 percent (i.e., decrease in G″) to 7741 percent (i.e., increase in G″), indicating both an increase and a decrease in their fluidity, respectively. CONCLUSIONS: The increase in G' would indicate the transition from a "softer" to a "harder" filler, and the observed decrease in G″ would indicate an increase in the filler's "fluidity." Changes in the frequency of applied shear forces such as those occurring in the medial versus the lateral face will influence the aesthetic outcome of soft-tissue filler injections.


Assuntos
Técnicas Cosméticas , Preenchedores Dérmicos/química , Face/fisiologia , Ácido Hialurônico/química , Movimento/fisiologia , Fenômenos Biomecânicos , Preenchedores Dérmicos/administração & dosagem , Elasticidade , Humanos , Ácido Hialurônico/administração & dosagem , Reologia/estatística & dados numéricos , Viscosidade
16.
Dermatol Surg ; 47(10): 1359-1364, 2021 10 01.
Artigo em Inglês | MEDLINE | ID: mdl-34417392

RESUMO

BACKGROUND: Facial aging is characterized by volume loss and progressive hollowing of temples and cheeks. Biodegradable filler materials are preferred over nonabsorbable materials; of these, hyaluronic acid (HA) fillers are the most often used because of their favorable effectiveness and safety profile. OBJECTIVE: To confirm the safety and effectiveness of Cohesive Polydensified Matrix (CPM)-HA26 gel in the treatment of volume deficiency. METHODS: Subjects received up to 2 treatments in the temples and/or cheeks. A blinded investigator assessed improvement according to the Merz Temple Volume Scale (MTVS) and Merz Cheek Fullness Assessment Scale (MCFAS). Subjects were followed for 48 weeks after the last treatment. RESULTS: In total, 87 healthy subjects were enrolled. The proportion of subjects achieving at least a 1-grade improvement on MTVS and/or MCFAS was above 70% for each (MTVS: Weeks 4, 24, and 48 = 95.4%, 94.2%, and 77.0%; MCFAS: Weeks 4, 24, and 48 = 92.3%, 83.1%, and 71.8%). Based on MTVS and MCFAS scores at Visit 5, improvement remained visible at up to 48 weeks. No treatment-related serious AEs occurred. CONCLUSION: CPM-HA26 demonstrated both a favorable safety and effectiveness profile, with improvement in facial volume evident for up to 48 weeks. It was well tolerated and had a positive, long-lasting effect.


Assuntos
Técnicas Cosméticas/efeitos adversos , Preenchedores Dérmicos/efeitos adversos , Ácido Hialurônico/efeitos adversos , Adulto , Envelhecimento , Bochecha , Preenchedores Dérmicos/administração & dosagem , Preenchedores Dérmicos/química , Feminino , Seguimentos , Voluntários Saudáveis , Humanos , Ácido Hialurônico/administração & dosagem , Ácido Hialurônico/química , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Resultado do Tratamento
17.
Aesthet Surg J ; 41(5): NP226-NP236, 2021 04 12.
Artigo em Inglês | MEDLINE | ID: mdl-33544840

RESUMO

BACKGROUND: The most severe complications following soft tissue filler injections result from the intraarterial administration of the filler product. Although hyaluronic acid-based filler can be trans-arterially dissolved with hyaluronidase, no information is available on calcium hydroxylapatite (CaHA)-based fillers. OBJECTIVE: The authors sought to test whether CaHA-based fillers can be trans-arterially dissolved by sodium thiosulfate (STS) when evaluated in cadaveric and in vitro models. METHODS: Human cadaveric facial arterial segments were each filled with 0.2 cc of commercially available CaHA product and submerged for 24 hours in 4 different STS-containing solutions: 10 cc STS (300 mg/cc) (pure, 1:1 dilution, 1:2 dilution), 0.9% saline and 10 cc STS (300 mg/cc), and 300 IU (bovine) hyaluronidase in a 1:1 ratio. RESULTS: Intraarterial CaHA was detected in human facial artery segments after 24 hours independent of the STS concentration employed. Submerging the arterial segments in STS (300 mg/cc) and 300 IU (bovine) hyaluronidase (1:1 ratio) also did not dissolve the intraarterial CaHA product. Gray scale analyses did show, however, that increasing concentrations of STS resulted in increased disintegration of CaHA in an in vitro experimental setting. CONCLUSIONS: The results of this study indicate that STS is limited in its potential to dissolve intraarterial CaHA of cadaveric human facial arteries, despite the fact that it appears effective when in direct contact with the CaHA. Adverse events caused by intraarterial administration of CaHA-based fillers still lack a suitable antidote.


Assuntos
Técnicas Cosméticas , Preenchedores Dérmicos , Animais , Materiais Biocompatíveis , Cadáver , Cálcio , Bovinos , Preenchedores Dérmicos/efeitos adversos , Durapatita , Humanos , Tiossulfatos
18.
Plast Reconstr Surg Glob Open ; 9(12): e3973, 2021 Dec.
Artigo em Inglês | MEDLINE | ID: mdl-35070607

RESUMO

BACKGROUND: There is a growing interest in the application of hyaluronic acid (HA) derivatives in skin quality improvement. The aim of this study was to confirm safety and effectiveness of cohesive polydensified matrix-hyaluronic acid + glycerol (CPM-HA20G; Belotero Revive) in revitalization of early-onset photodamaged facial skin. METHODS: A total of 159 subjects with early signs of facial photodamaged skin were randomized in a 2:1 ratio to multiple- or single-dose treatment with CPMHA20G. Effectiveness assessments included biophysical measurements of skin hydration; elasticity, firmness, and roughness; investigator- and subject-assessed Global Aesthetic Improvement Scales; and FACE-Q Skin Changes and Treatment Satisfaction questionnaires. RESULTS: In both treatment groups, skin hydration improved from baseline to all follow-up visits in subjects with dry or very dry skin. This improvement was significant at week 16 after initial treatment in the multiple-dose group (P = 0.0013). Investigator- and subject-reported outcomes showed that the majority of subjects across all skin hydration types benefited from treatment, with higher satisfaction rates observed in the multiple-dose group. According to investigator-assessed Global Aesthetic Improvement Scale, 90.7% of subjects at week 12 in the multiple-dose and 74.6% of subjects at week 4 in the single-dose group were rated as at least "improved." All related treatment-emergent adverse events were transient, expected injection-site reactions of mild to moderate intensity. CONCLUSIONS: Effectiveness of CPM-HA20G for skin hydration in subjects with dry or very dry skin was demonstrated up to 9 months after last injection. Overall, CPM-HA20G demonstrated effective and safe use in facial skin revitalization among subjects with early-onset photodamaged skin.

19.
J Cosmet Dermatol ; 20(5): 1385-1392, 2021 May.
Artigo em Inglês | MEDLINE | ID: mdl-33251687

RESUMO

BACKGROUND: Differences in the effectiveness of neuromodulator treatments for horizontal forehead lines dependent on depth of product administration have been described. However, knowledge in respect to the fascial anatomy of the forehead still remains elusive. AIMS: To relate the fascial anatomy of the forehead to the effectiveness of neuromodulator treatments by conducting a clinical, prospective, interventional split-face study in which injections for the treatment of horizontal forehead lines are performed differently between facial sides. METHODS: This study included a total of n = 14 patients with a mean age of 35.71 (7.8) years and mean body mass index of 21.9 (3.0) kg/m2 . One side of the forehead was injected superficially by positioning the product in the superficial fatty layer, whereas the contralateral side was injected deep targeting the supraperiosteal plane (random selection). The treatment outcome was rated by the physician and by two independent observers according to a forehead line severity scale (0-4) at 14 and at 30 days. RESULTS: All three observers agreed in their ratings (ICC: 0.942) that the deep injection technique resulted in a superior outcome: D14 (superficial vs deep) 0.17 (0.4) vs 0.14 (0.4; P = .583) at rest and 1.26 (0.6) vs 0.43 (0.5; P < .001) for frontalis contraction; D30 0.17 (0.4) vs 0.14 (0.3) at rest (P = .583) and 1.21 (0.6) vs 0.43 (0.5; P < .001) for frontalis contraction. CONCLUSION: The results of this study underscore how detailed anatomic knowledge can enhance results of aesthetic interventions, in this case horizontal forehead line treatment with neuromodulators.


Assuntos
Toxinas Botulínicas Tipo A , Fármacos Neuromusculares , Envelhecimento da Pele , Adulto , Testa , Humanos , Neurotransmissores , Estudos Prospectivos
20.
Clin Cosmet Investig Dermatol ; 13: 371-378, 2020.
Artigo em Inglês | MEDLINE | ID: mdl-32547150

RESUMO

BACKGROUND AND OBJECTIVES: There is a wide diversity of opinions regarding the management of delayed inflammatory reactions (DIRs) secondary to hyaluronic acid (HA)-based fillers. The plethora of approaches has led the authors to conduct a review regarding management and treatment of DIRs as well as establish therapeutic guidelines for this purpose. MATERIALS AND METHODS: A review of the literature was performed through databases such as PubMed using keywords including HA-fillers and complications, delayed HA filler sequelae and therapy, soft tissue and dermal filler reactions and management. Additionally, a survey comprised of questions regarding the management and treatment of DIRs was sent to 18 physicians highly experienced with soft-tissue filler injections in 10 countries. Their answers and recommendations were analyzed and debated amongst these panelists. RESULTS: Sixteen panelists favored antibiotic therapy as first-line treatment for DIRs, specifically dual antibiotic therapy consisting of a fluoroquinolone along with a tetracycline or macrolide for a period of 3-6 weeks. The majority refrained from the use of intralesional (IL) or systemic steroids except in the case of disfiguring or recalcitrant reactions. IL hyaluronidase was recommended by 13 panelists; however, some preferred a watchful waiting approach for a period of 48 hours to 2 weeks prior to IL hyaluronidase, and in cases where antibiotics did not lead to improvement. CONCLUSION: A consensus was reached and summarized to propose a clear, easy-to-follow, stepwise algorithm for the treatment of DIRs.

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