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1.
OBJECTIVE: We sought to analyze the current literature regarding time to onset and duration of effect of abobotulinumtoxinA (aboBoNT-A, Dysport®/Azzalure®) for upper facial aesthetic indications. METHODS: We conducted a systematic review of literature databases (PubMed/MEDLINE, Embase, Cochrane Library, and Google Scholar) to identify English-language publications relevant to: population (patients with aesthetic indications [including glabellar lines and wrinkles]); interventions (aboBoNT-A); comparators (no restrictions); outcomes (efficacy, including onset of action and duration of effect); and settings (clinical). A manual search of review paper bibliographies was performed. Structured data extraction was used to enable interstudy analysis. RESULTS: Overall, 42 original research papers relevant to aboBoNT-A onset and/or duration were identified. All 24 studies assessing efficacy within one week post-injection demonstrated some response at the first time point assessed, and all 37 studies assessing duration showed some response after 12 weeks. Although methodologies for assessing onset and duration differed, when outcomes were refined by reported mean/median, at least 50 percent of patients responding to treatment, or significance versus placebo or baseline at a given time point, onset was most often reported within 2 to 3 days (7 studies), and as early as 24 hours (2 studies). Duration was most often reported as four months (18 studies), although four studies provided evidence that aboBoNT-A efficacy was maintained at five months and three studies at or after six months post-injection. CONCLUSION: This review indicates that aboBoNT-A has a median onset of efficacy of 2 to 3 days and a longer duration of action (3–6 months across studies) than the current labelled minimum treatment interval (12 weeks).  相似文献   

2.
BackgroundAs aesthetic preferences have evolved and patients wish their muscles to be relaxed, but not frozen, a higher dilution of incobotulinumtoxinA (INCO) has allowed for increased spread using fewer units, yet no studies to date have investigated the efficacy, longevity, and safety of hyperdiluted INCO.ObjectiveWe evaluated the effect of incobotulinumtoxinA (INCO) in glabellar, forehead, and lateral periorbital lines using a high dilution.MethodsSubjects with moderate-to-severe upper facial lines at rest according to the Merz Aesthetics Scales (Merz Pharmaceuticals GmbH, Frankfurt am Main, Germany) received 15U of INCO to the glabellar (n=4 injection sites), 10U to the rest of the forehead (n=10 injection sites), and 5U to the lateral periorbital lines (n=3 injection sites/eye). Primary outcomes were physician- and subject-rated improvement at one month using the Global Aesthetic Improvement Scale (GAIS) and changes in line severity using the Merz Aesthetics Scales.ResultsThe study included 15 women aged 35 to 65 years. At one month, physician GAIS scores indicated 91.2% of subjects were very much improved and 8.8% were much improved; 91.5%, 78.0%, and 57.6% of participants remained at least improved at four, five, and six months, respectively. Subject GAIS scores at one month were in agreement with physician scores. At one month, an improvement of at least one point in Merz Aesthetics Scales scores in glabellar, forehead, and lateral periorbital lines was reported in 88.9%, 98.3%, and 94.8% of participants, respectively. Subject satisfaction was high throughout the study. No treatment-related adverse events were observed.ConclusionHyperdilute INCO was effective at improving overall appearance and reducing line severity in individuals with moderate-to-severe upper facial lines. Patient satisfaction was maintained up to six months and treatment was well tolerated.  相似文献   

3.
BACKGROUND: Systematic, well-controlled clinical trials of botulinum toxin type A (BoNTA) in diverse patient populations are needed. The aim of this study was to characterize the safety and efficacy of 10-U and 20-U BoNTA doses versus placebo for treating glabellar lines in Japanese subjects. METHODS: A 16-week, multicenter, double-blind, randomized, placebo-controlled trial comparing 10 or 20 U of BoNTA versus placebo in 142 Japanese subjects with glabellar lines of at least moderate severity at maximal contraction. The primary efficacy endpoint was physician-rated line severity at maximal contraction 4 weeks after treatment. Secondary efficacy endpoints included physician/subject ratings and estimates of the effect's duration. RESULTS: Response rates by physician-rated line severity at maximal contraction (week 4) were 86.4% (10 U), 88.6% (20 U), and 0% (placebo, p < 0.001). Line severity at maximal contraction in each BoNTA group (p < 0.001) improved significantly from baseline at each visit. BoNTA and placebo differed significantly on all other efficacy measures. Mean duration of effect was 9.4 weeks in the 20-U group and 7.9 weeks in the 10-U BoNTA group. No serious adverse events occurred. CONCLUSION: Doses of BoNTA of 10 and 20 U are effective and safe for treating glabellar lines in Japanese subjects, and the 20-U dose provides greater efficacy and longer duration of effect.  相似文献   

4.
OBJECTIVE: To evaluate the clinical efficacy and patient satisfaction of Radiance FN (fine needle) (BioForm Inc, Franksville, Wis), a highly biocompatible, calcium hydroxylapatite-based implant, when used for facial soft tissue augmentation. METHODS: Ninety patients aged between 25 and 85 years underwent subdermal injection with Radiance FN. The primary areas treated were lips, nasolabial folds, glabellar rhytids, marionette lines, prejowl depressions, acne scars, and surgical soft tissue defects. Patients were surveyed after treatment and for up to 6 months for pain, ecchymosis, skin erythema, nodules, softness, appearance, and satisfaction. RESULTS: In terms of efficacy, at 6 months, appearance, softness, and overall patient satisfaction were rated good or excellent in 74%, 80%, and 88% of patients, respectively. Moderate or severe pain occurred with injection in 59% of patients but disappeared 2 to 5 minutes after injection. Erythema, edema, and ecchymosis were common immediately after treatment but resolved in all patients within 2 weeks. Seven patients had persistent visible mucosal lip nodules, 4 of whom required intervention. CONCLUSIONS: Radiance FN is highly effective and well tolerated when used for facial soft tissue augmentation. Additional experience with longer follow-up will help determine the most appropriate use and long-term safety for the implant.  相似文献   

5.
李传荣 《中国美容医学》2014,23(17):1418-1420
目的:探讨联合应用A型肉毒毒素与软组织填充剂治疗眉间纹的临床疗效。方法:研究对象为2012年7月~2013年7月我院接受治疗的68例眉间纹患者,其中26例行软组织填充治疗(设为对照组),42例联合应用A型肉毒毒素与软组织填充剂治疗(设为治疗组),统计疗效、患者满意率及并发症发生率。结果:治疗组的疗效及患者满意率均显著高于对照组,两组差异具有统计学意义(χ2=18.114、10.056,P0.05)。两组均未出现严重不良反应。结论:联合应用A型肉毒毒素与软组织填充剂治疗眉间纹疗效佳,并发症发生率低,值得推广应用。  相似文献   

6.
目的 探究A型肉毒素对注射整形美容的效果。方法 选取2022年3月-2023年1月我院收治的120例 注射整形美容的患者作为研究对象,以患者面部情况分为额纹组、鱼尾纹组、眉间纹组,每组40例。所 有研究对象均予以A型肉毒素注射治疗,比较三组临床疗效、不良反应发生情况、治疗满意度、心理情 绪。结果 额纹组治疗总有效率高于鱼尾纹组和眉间纹组,差异有统计学意义( P <0.05);额纹组不良 反应发生率低于鱼尾纹组和眉间纹组,但差异无统计学意义( P >0.05);额纹组治疗满意度高于鱼尾纹 组和眉间纹组,差异有统计学意义( P <0.05);额纹组心理情绪优于鱼尾纹组及眉间纹组,差异有统计学 意义( P <0.05)。结论 A型肉毒素应用于各种面部问题中均能够取得较为满意的治疗结果,且在额纹改善 中的应用效果更高,能清除患者面部皱纹,提高整形满意度,值得临床使用。  相似文献   

7.
透明质酸与肉毒毒素联合注射治疗重度眉间纹   总被引:1,自引:0,他引:1  
目的探讨透明质酸与肉毒毒素联合注射治疗眉间纹的适应证、注射方法和临床效果。方法选择67例严重眉间纹患者,联合应用透明质酸(0.3~0.8m1)和肉毒毒素(9~14U)注射治疗,观察注射后的临床效果、疗效时间和不良反应等。结果透明质酸与肉毒毒素联合注射后,静态眉间纹即刻得到明显改善;注射后2、3d,动态皱眉纹开始逐渐减轻;约1个月时,效果明显改善。随访3~12个月,术后皱纹改善满意,最长可达18个月。结论对重度眉间纹(同时具有静态和动态皱眉纹)的患者,应用透明质酸行皱纹内填充,并结合肉毒毒素对眉间复合体肌肉进行注射,可达到更好的治疗效果。  相似文献   

8.
BACKGROUND: Botulinum toxin type A treatment is a safe and effective treatment for facial lines. Patient satisfaction with treatment has not yet been systematically measured and reported. OBJECTIVE: To create a valid and reliable questionnaire to assess patient satisfaction with facial line treatment and to assess treatment satisfaction in facial line patients. METHODS: Development of the Facial Line Treatment Satisfaction (FTS) Questionnaire followed the five-step process recommended by the Patient Reported Outcomes Harmonization Committee. RESULTS: One hundred fifty-two pilot test participants received botulinum toxin type A treatment alone or in combination with a minimally invasive facial line treatment and were satisfied or very satisfied with their facial lines treatment. CONCLUSION: The FTS is a valid and reliable 14-item questionnaire that measures an aesthetic patient's satisfaction with facial line treatment. The FTS can be used in clinical practice or clinical trials of facial line treatments. Botulinum toxin type A treatment is associated with high patient satisfaction.  相似文献   

9.
OBJECTIVE: To compare the efficacy, safety, and duration of effect of four doses of botulinum toxin type A in the treatment of glabellar rhytids in females. DESIGN: Double-blind, randomized, parallel-group, dose-ranging trial followed by an open-label extension. SETTING: Private dermatologic clinic. SUBJECTS: Eighty female subjects with moderate to severe wrinkles at maximum frown entered the study. The first 40 subjects completing the double-blind phase entered the open-label extension. INTERVENTION: Random administration of 10, 20, 30, or 40 U botulinum toxin type A in divided doses. Open-label trial: 30 U botulinum toxin type A at the same sites in divided doses. MAIN OUTCOME MEASUREMENTS: Trained observer and subject assessments of wrinkle severity at maximum frown and repose using the Facial Wrinkle Scale (0 = none to 3 = severe), subject satisfaction, and adverse events. Follow-up monthly for up to 1 year postinjection. RESULTS: Relapse rates and responder rates revealed benefits lasting 3 to 6 months or longer. Objectively, 10 U of botulinum toxin type A was significantly less effective than 20, 30, or 40 U. The relapse rate at 4 months was significantly higher in the 10 U group (83%) versus 40, 30, or 20 U (28%, 30%, and 33%, respectively). Subject satisfaction was high in all groups. Duration of effect and response rates were sustained during the open-label extension. Adverse effects were mild and infrequent. CONCLUSION: Twenty to 40 U botulinum toxin type A doses were significantly more effective at reducing glabellar lines than 10 U. Most subjects experienced benefits for 3 to 4 months; some subjects demonstrated effect for up to 12 months.  相似文献   

10.
Botox and collagen for glabellar furrows: advantages of combination therapy   总被引:1,自引:0,他引:1  
Patel MP  Talmor M  Nolan WB 《Annals of plastic surgery》2004,52(5):442-7; discussion 447
Plastic surgeons frequently administer botulinum toxin A (Botox) or collagen as monotherapy to treat glabellar furrows. This study evaluates the possible advantages of combination therapy. Sixty-five patients with moderate to severe glabellar rhytids were prospectively randomized to receive standard injections of Botox, Zyderm II collagen, or a combination. Improvement in rhytids was assessed over 3 months using patient satisfaction scores and an independent physician evaluation. Baseline wrinkle severity was similar in all 3 groups. By 1 month posttreatment, the combination arm showed significantly greater improvement in furrows (79% compared with only 56% and 50% in the Botox and Zyderm arms, respectively; P < 0.05). At 3 months postinjection, the dual-therapy arm maintained better improvement (57% versus 33% and 27% in the monotherapy arms; P < 0.05). Patient satisfaction further highlighted the superiority of the combination approach. By simultaneously addressing the static and dynamic aspects of glabellar furrows, dual therapy provides optimal treatment of this problem.  相似文献   

11.
Background. Botulinum toxin type A treatment is a safe and effective treatment for facial lines. Patient satisfaction with treatment has not yet been systematically measured and reported.
Objective. To create a valid and reliable questionnaire to assess patient satisfaction with facial line treatment and to assess treatment satisfaction in facial line patients.
Methods. Development of the Facial Line Treatment Satisfaction (FTS) Questionnaire followed the five-step process recommended by the Patient Reported Outcomes Harmonization Committee.
Results. One hundred fifty-two pilot test participants received botulinum toxin type A treatment alone or in combination with a minimally invasive facial line treatment and were satisfied or very satisfied with their facial lines treatment.
Conclusion. The FTS is a valid and reliable 14-item questionnaire that measures an aesthetic patient's satisfaction with facial line treatment. The FTS can be used in clinical practice or clinical trials of facial line treatments. Botulinum toxin type A treatment is associated with high patient satisfaction.  相似文献   

12.
Clinical Trial ID: NCT0454597BACKGROUND: Mimetic wrinkles, commonly referred to as expression lines, form perpendicular to anatomical regions subjected to repeated facial muscle contraction. Neuromodulating peptides have biological activity and can offer a solution to those concerned with expression lines and facial aging. OBJECTIVE: The objective of this randomized, double-blind, placebo-controlled study was to assess the efficacy and tolerability of a line-targeting peptide serum (LTPS) as a stand-alone treatment in improving expression lines and skin health. METHODS: This was an institutional review board-approved study involving healthy subjects. Fifty-five female subjects, 35 to 60 years old, Fitzpatrick Skin Type I to VI, with mild to moderate global face fine lines and wrinkles were recruited. Subjects were randomized to apply LTPS or a placebo serum to their face twice daily for twelve weeks. Short-term efficacy was assessed after fifteen minutes of serum application at baseline. Long-term efficacy and tolerability, self-assessment questionnaire, and VISIA® clinical photography were performed at baseline, Weeks 4, 8, and 12. 3D PRIMOS CR imaging and wrinkle analysis were obtained at baseline and Weeks 8 and 12. RESULTS: The LTPS significantly improved expression lines at fifteen minutes (short term), Weeks 4, 8, and 12 (long term) when compared to the placebo serum as evaluated by a board-certified dermatologist. The LTPS significantly outperformed the placebo serum in improving skin parameters at all time points. VISIA and PRIMOS CR wrinkle analysis substantiated the LTPS’s efficacy. LTPS was well-perceived and well tolerated by the subjects. CONCLUSION: This IRB-approved clinical study demonstrated that LTPS was effective in improving expression lines, wrinkles, and skin health after twelve weeks of application.  相似文献   

13.
BACKGROUND: Botulinum toxins have been proven effective for reducing facial lines. There are two commercial types of botulinum toxin type A available in many countries but no published comparison studies. OBJECTIVE: To compare the efficacy and tolerability of Botox Cosmetic and Dysport 50 U in the treatment of glabellar lines (using 20 U of Botox Cosmetic, which is the dose approved by the US Food and Drug Administration for the treatment of glabellar lines, and 50 U of Dysport, which has been reported to be the optimal dose for this formulation). STUDY DESIGN: Parallel-group double-blind pilot study. Evaluation by observing physician, photographic, and patient evaluations. CONCLUSION: Botox 20 U provided better and more prolonged efficacy than Dysport 50 U in the treatment of glabellar lines.  相似文献   

14.
OBJECTIVE: To evaluate the presence of imprinted facial lines in identical twin sisters, one of whom had received botulinum toxin type A (Botox) treatment in the forehead and glabellar region regularly for 13 years and one of whom had not. Crow's feet were also compared. METHODS: One twin received Botox in the forehead and glabellar region (approximately 2 to 3 times each year over the past 13 years) and in the crow's feet (twice in past 2 years). Her twin received Botox only twice (in the forehead and glabellar region, 3 and 7 years ago). RESULTS: Imprinted forehead and glabellar lines were not evident in the regularly treated twin but were evident in the minimally treated twin. Crow's feet were less noticeable when the regularly treated twin smiled (even at 7 months after treatment) than when the minimally treated twin smiled. Untreated facial areas (eg, nasolabial folds) showed comparable aging in both twins. Neither twin experienced adverse effects. CONCLUSIONS: Long-term treatment with Botox can prevent the development of imprinted facial lines that are visible at rest. Botox treatment can also reduce crow's feet. Treatment is well tolerated, with no adverse events reported during 13 years of regular treatment in this study.  相似文献   

15.
BackgroundThe combination of benzoyl peroxide and a new topical therapy, such as topical niacinamide, reduces facial sebum production and also has a skin-lightening effect. This combined treatment might lead to improved efficacy in the treatment of facial acne vulgaris while also promoting the resolution of postacne erythema and postinflammatory hyperpigmentation.ObjectiveThe primary objective was to evaluate and compare the clinical efficacy of topical 2.5% benzoyl peroxide plus 5% niacinamide and 2.5% benzoyl peroxide with cream base for mild to moderate facial acne vulgaris. Secondary objectives were to evaluate and compare clinical efficacy regarding postinflammatory hyperpigmentation, postacne erythema, reduction of facial sebum production, and side effects. METHODS: Patients with mild to moderate facial acne vulgaris and aged 18 to 40 years were enrolled. Treatment was randomly assigned to the left or right side of the face for 12 weeks. Both inflammatory and noninflammatory acne lesions were counted by a physician, and the postinflammatory hyperpigmentation score and postacne erythema score were calculated using an Antera 3D® camera (Miravex, Dublin, Ireland). Sebum casual level was measured using a Sebumeter® (Courage+Khazaka Electronic, Köln, Germany) every two weeks. Physician improvement score, patient satisfaction index, and side effects were assessed by evaluation forms every two weeks.ResultsAt Week 12, the niacinamide group (5% niacinamide+2.5% benzoyl peroxide) showed significant reduction in both the acne lesion count and sebum casual levels from baseline (p=0.000 and p=0.001, respectively). The reduction in noninflammatory lesion count in the niacinamide group was better than that in the cream base group (2.5% benzoyl peroxide+cream base), with a statistically significant difference (p=0.004). However, the reduction in inflammatory lesions was not significantly different between the two groups. The sebum casual level in the niacinamide group was reduced faster than that in the cream base group. The postacne erythema score was reduced from baseline in both groups, with no statistically significant difference within or between the two groups. The postinflammatory hyperpigmentation score showed increases in both groups above the baseline, with a statistically significant difference in the cream base group (p=0.000) but no such difference in the niacinamide group (p=0.58). There was no statistically significant difference between the two groups. Furthermore, no statistically significant differences were found between the two groups at every follow-up visit in terms of physician improvement scale, patient satisfaction index, or side effects.Conclusion The combination of 2.5% benzoyl peroxide and 5% niacinamide is more effective than 2.5% benzoyl peroxide alone for mild to moderate facial acne vulgaris.  相似文献   

16.

INTRODUCTION

The Triathlon® (Stryker, Kalamazoo, MI, US) total knee replacement was designed to improve patient function and survivorship. The aim of this study was to determine whether the Triathlon® prosthesis produces better patient reported outcomes than a previous design by the same manufacturer, the Kinemax Plus.

METHODS

The outcome of 233 knees of patients with a mean age of 68 years (range: 40–80 years) who received the Kinemax Plus prosthesis were compared with the outcomes of 220 knees of patients with a mean age of 70 years (range: 42–90 years) who received the Triathlon® prosthesis. Data were collected via postal questionnaire prior to surgery as well as at 8–12 weeks and at 1 year following surgery. Validated questionnaires were used including the WOMAC® (Western Ontario and McMaster Universities) pain and function scales, the Knee injury and Osteoarthritis Outcome Score quality of life scale and the self-administered patient satisfaction scale.

RESULTS

This study found that patients who had the Triathlon® prosthesis had significantly better pain relief (p<0.0001), function (p=0.028), knee related quality of life (p<0.0001) and satisfaction (p=0.0003) at three months after surgery than those who received the Kinemax Plus prosthesis. In addition, knee related quality of life (p=0.002) and satisfaction (p=0.021) were significantly higher at one year after surgery in Triathlon® patients.

CONCLUSIONS

The findings suggest that return to function and reduction in pain may occur more quickly in patients with a Triathlon® prosthesis than in those with the Kinemax Plus.  相似文献   

17.
BackgroundSeveral usage guidelines for calcium hydroxylapatite (CaHA), a dermal filler material, exist for non-Asian patients, making it necessary to determine whether their findings and consensuses are applicable to Asian patients who have distinct anatomies, cultural preferences, and aesthetic requests.ObjectiveWe sought to develop a Pan-Asian consensus on CaHA use in skin biostimulation, contouring, and combination treatments for face and body indications.MethodsA survey on CaHA usage for contouring and biostimulation indications in Asian patients was conducted, followed by discussions to establish consensus statements and topics for examination.ResultsSeveral aspects of facial shaping and contouring or skin biostimulation with CaHA were agreed on, including that dilution is not a key consideration, that microfocused ultrasound with visualisation precedes CaHA in same day or session treatments, and that cannulas should be used. Among the many agreements on interventions in specific facial and body areas, there were also disagreements due to the diverse Asian patient presentations, requests, and access to tools or products; for example, CaHA should be placed in the interfascial layer for temple contouring, CaHA should not be injected directly into the infraorbital area for safety, and diluted CaHA should be injected subdermally for nonfacial or whole-face biostimulation and contouring.ConclusionOur disagreements highlight the diversity of Asian facial morphotypes and desired aesthetic outcomes and underscore the need for customized aesthetic strategies to accommodate the heterogeneity of Asian anatomies, cultural preferences, and aesthetic ideals. Establishing consensus statements on critical aspects of Asian patient considerations, efficacy and safety, is crucial. This document provides strategic guidance on the use of classic, diluted CaHA for biostimulation or undiluted Radiesse®(+) (Merz Pharma GmbH & Co. KGaA, Frankfurt, Germany) for lifting and contouring to ensure consistent CaHA delivery for successful patient outcomes.  相似文献   

18.
19.
Objective: Cohesive Polydensified Matrix® Hyaluronic Acid Volumizer is designed to be injected subcutaneously or in deeper soft tissue layers to restore facial volumes. This post-marketing clinical follow-up was performed to confirm the safety and effectiveness of the product up to 18 months. Design: Injections were performed according to standard clinical practice and patients were followed-up at Months 1, 3, 6, 9, 12, and optionally at Month 18. Effectiveness measures included facial volume loss scale, global aesthetic improvement scale and patients’ satisfaction. Injection site reactions were recorded to evaluate safety. Results: Twenty patients with intermediate-to-severe volume loss in the lateral cheek hollows and/or cheekbone area were treated. Facial volume loss scale scores dropped significantly from a mean value of 3.1 at baseline to 1.3 at Day 1. Significant volume enhancement was maintained at each follow-up visit with mean scores ranging from 1.3 at Month 1 to 1.8 at Month 12. Investigators’ global aesthetic improvement scale assessment showed that up to Month 6 at least 94 percent of patients were rated as “very much improved” or “much improved.” At Month 9, all patients still showed a benefit of treatment with 81 percent rated as “very much” or “much improved” and 19 percent as “improved.” Patients’ evaluation was consistent with investigators’ results. A few expected transient injection site reactions of mild-to-moderate intensity were reported immediately after treatment. These reactions were considered related to the injection procedure, rather than the product. Conclusion: Cohesive Polydensified Matrix Hyaluronic Acid Volumizer is safe and effective for mid-face volume augmentation lasting up to Month 12 and most probably up to Month 18. The aesthetic effect was demonstrated by the effectiveness evaluations and high patient satisfaction.With an increase in average life expectancy and a historical strive for beauty, a growing interest in methods to achieve a natural, rejuvenated, and youthful appearance is expressed by many individuals worldwide. Minimally invasive non-permanent rejuvenation methods, such as injectable dermal fillers based on cross-linked sodium hyaluronate have become one of the most frequently performed aesthetic procedures.1 They represent a versatile and elegant tool for facial sculpting, contouring, and treatment of facial wrinkles. Currently available fillers differ in composition, duration of action, palpability, administration techniques, complications, and other factors.2Hyaluronic acid (HA) is a naturally occurring glycosaminoglycan with a strong hydrophilic capacity. In the dermal extracellular matrix it provides structural support and plays a role in nutrient exchange as well as adding volume and fullness to the skin.3,4 Natural HA in the skin has an extremely rapid rate of turn-over, mostly due to catabolism by endogeneous hyaluronidases.5 Therefore, commercially available HAs are stabilized by different manufacturing technologies. As a result, the products vary in formulation, concentration, and degree of cross- linking. These properties affect the duration of action as well as post-procedural risks of swelling.2Cohesive Polydensified Matrix® (CPM®) Hyaluronic Acid (HA) Volumizer (Modélis® SHAPE, Anteis S.A, Geneva, Switzerland; also commercialized as Belotero® Volume, Merz Pharmaceuticals GmbH, Frankfurt, Germany) is a CE-marked dermal filler manufactured with the patented CPM technology. It is composed of 26mg/mL HA from biofermentation origin cross-linked with 1,4-butanediol diglycidyl ether (BDDE). CPM HA volumizer is designed to be injected subcutaneously or in deeper soft tissue layers to restore facial volumes. The CPM technology creates a product with variable cross-linking densities within the gel, where denser areas ensure volumizing effect and less dense areas ensure cohesivity of the matrix. These properties allow the gel to be easily extruded through the needle during the injection and prevent it from migrating once implanted. CPM HA volumizer is also characterized by the plasticity of the gel, which allows the practitioner to mold and sculpt the product easily into the desired shape once injected in order to achieve optimal aesthetic results.Facial volume loss is one of the major signs of aging, but it can also be inherited or acquired through disease or trauma.6 During facial aging, the atrophy of the underlying skeleton becomes prominent and subcutaneous cell components (fat, muscle, and fascia) progressively break down resulting in an altered shape and relative position of the fat pads.7-9 Volumetric changes in the mid-face area are associated with a sad and tired look. Enhancement of the lateral cheek hollows and cheekbone area recreates mid- face volume, smoothens nasolabial folds, and gives a more harmonious appearance associated with a younger age.10,11The objective of this post-marketing clinical follow-up was to confirm the safety and effectiveness of CPM HA volumizer for enhancement of the lateral cheek hollows and cheekbone area. The durability of the aesthetic effect was evaluated up to 18 months.  相似文献   

20.
BACKGROUND Global patient-reported outcomes do not evaluate specific aspects of treatment that are important to patients.
OBJECTIVE The objective was to evaluate self-perception of age and specific outcomes that are important to patients receiving botulinum toxin type A or placebo for moderate to severe glabellar lines (using the Facial Line Outcomes Questionnaire to assess how much facial lines bother them, make them look older, detract from their facial appearance, prevent a smooth facial appearance, and make them look tired, stressed, or angry).
METHODS AND MATERIALS In the double-blind phase of this 12-week study, 70 patients were randomly assigned to treatment with 20 U botulinum toxin type A (BOTOX Cosmetic) or placebo. At Week 4, those still with moderate or severe glabellar lines were offered open-label 20 U botulinum toxin type A.
RESULTS Median glabellar line severity was significantly lower after botulinum toxin treatment than after placebo. Compared with placebo, botulinum toxin also resulted in significantly superior patient assessments and a greater proportion of patients considering they looked younger than their current age.
CONCLUSIONS Botulinum toxin type A can achieve specific goals of treatment that are important to patients and help them feel that they look younger than their current age.  相似文献   

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