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1.
Skin Res Technol ; 30(7): e13838, 2024 Jul.
Article in English | MEDLINE | ID: mdl-39036993

ABSTRACT

BACKGROUND: Understanding the differences in soft tissue filler rheology and how these properties can impact clinical results is a fundamental concepts for any injector. This study aimed to assess the tissue integration characteristics of hyaluronic acid (HA) fillers manufactured with different technologies (Non-Animal Stabilized HA [HA-N] or Optimal Balance Technology [HA-O]) using ultra-high-frequency ultrasound. METHODS: Twelve female participants with mild-to-moderate midface volume loss and temporal hollowing were enrolled and treated with HA-N and/or HA-O. Participants were seen at five visits (screening/baseline [treatment], and Weeks 1 [optional touch-up], 4, 6, and 8 [follow-up visits]). Ultrasound was used to evaluate the degree of product integration. RESULTS: On ultrasound, HA-N presented with distinct borders, minimal tissue integration, and a capacity to displace tissues. Conversely, HA-O tended to spread horizontally within the same tissue plane and integrated within tissues. The volumizing capacity of the HA-O fillers was dependent on particle size. CONCLUSION: HA-N is suited for deep injections in areas such as the upper lateral cheek and under the muscle of the temporal region when a lifting effect is desired; HA-O is best suited for subcutaneous injections, in areas of dynamic movement or for patients with thin skin; and can be injected subcutaneously or supraperiosteally when a volumizing effect is desired.


Subject(s)
Cosmetic Techniques , Dermal Fillers , Hyaluronic Acid , Rheology , Hyaluronic Acid/administration & dosage , Hyaluronic Acid/chemistry , Humans , Female , Dermal Fillers/administration & dosage , Dermal Fillers/chemistry , Middle Aged , Adult , Esthetics , Ultrasonography/methods , Aged , Skin Aging/drug effects , Face/diagnostic imaging , Particle Size
2.
J Cosmet Dermatol ; 23(5): 1604-1612, 2024 May.
Article in English | MEDLINE | ID: mdl-38318685

ABSTRACT

BACKGROUND: The Restylane portfolio of soft tissue fillers spans a wide range of indications, due in part to their complementary manufacturing technologies [non-animal stabilized hyaluronic acid (NASHA) and Optimal Balance Technology (OBT/XpresHAn)]. Using an array of products, injectors can achieve a holistic, natural looking effect for their patients. However, with a wide range of products it may be difficult to choose an optimal combination. AIM: Simplify and align global use recommendations for NASHA versus OBT products. METHODS: Two pre-meeting surveys were completed by 11 key opinion leaders with international representation, with the goal of collecting information regarding their current injection practices for various anatomical regions of the face (i.e., temporal region, forehead, tear trough, lateral zygoma, anteromedial cheek, nose, pyriform aperture, nasolabial fold, perioral area, lips, labiomental crease, marionette lines, chin, and jawline). The data collected from these surveys was subsequently discussed in a consensus group meeting involving 11 voting members and 3 nonvoting members. RESULTS: Top product recommendations were identified for each anatomical area, along with secondary and tertiary recommendations that can also be used under defined circumstances. Recommendations were provided based on a consideration of elements such as patient features (e.g., skin thickness, bone structure), the desired aesthetic outcome, experience of the injector, and the preferred injection technique. CONCLUSION: A majority consensus regarding the top NASHA versus OBT product choice for each anatomical region of the face was reached. These recommendations represent international agreement regarding the use of Restylane products.


Subject(s)
Consensus , Cosmetic Techniques , Dermal Fillers , Face , Hyaluronic Acid , Hyaluronic Acid/administration & dosage , Humans , Dermal Fillers/administration & dosage , Cosmetic Techniques/instrumentation , Cosmetic Techniques/standards , Skin Aging/drug effects , Gels , Practice Guidelines as Topic
3.
Article in English | MEDLINE | ID: mdl-38230304

ABSTRACT

Background: Hyaluronic acid (HA) fillers are used to treat an array of aesthetic indications. Proper filler selection is paramount for successful patient outcomes. However, many important physiochemical and physical properties that impact HA gel behavior remain undefined. Purpose: To evaluate the hydrophilicity, cohesivity and particle size of eight commercial HA fillers manufactured by either Non-Animal Stabilized Hyaluronic Acid (NASHA) or Optimal Balance Technology (OBT) techniques. Methods and Materials: Three individual in vitro experiments were performed to assess HA swelling capacity, cohesion, and particle size. Image analyses, blinded evaluation using the Gavard-Sundaram Cohesivity Scale, and laser diffraction technology were utilized, respectively. Results: Compared to fillers manufactured with NASHA technology, OBT products demonstrated greater swelling capacity, cohesion, and wider particle size distributions. Strong positive correlations between swelling factor, degree of cohesivity, and increasing widths of the particle size distributions were observed. Conclusions: The hydrophilicity, cohesivity and particle size distributions vary among HA fillers manufactured with different techniques. The creation of new labels identifying products based on their unique combination of physiochemical and physical characteristics may help guide appropriate selection of HA fillers to optimize patient outcomes.

4.
Dermatol Surg ; 49(12): 1145-1151, 2023 12 01.
Article in English | MEDLINE | ID: mdl-37712833

ABSTRACT

BACKGROUND: Hyaluronic acid (HA) fillers may be manufactured to have distinctive physical properties that optimize their use for specific indications. Fillers manufactured with large gel calibration (particle size; HA-V) may be particularly suitable for volumizing large surface areas such as the temporal hollows. OBJECTIVE: To investigate the safety and effectiveness of HA-V for the treatment of temporal hollows. MATERIALS AND METHODS: A prospective, open-label, single-cohort, clinical trial was conducted. Twenty-six women who presented with bilateral temporal hollows at baseline were recruited. All subjects received treatment with HA-V and were observed at 4 to 5 in-person visits over 16 weeks. Subjective and objective measures of safety and efficacy parameters were collected through 2- and 3-dimensional imagery, questionnaires/scales (i.e., subject satisfaction, global aesthetic improvement, temporal hollowing severity), and adverse event diaries. RESULTS: To achieve optimal correction, the investigator used an average of 1.70 syringes per subject, per side. All treatments were performed using a bolus injection technique to place the product on the periosteum (bone) of the temporal region. Following optimal correction, all subjects (100%) displayed improvement in their global aesthetic appearance, and 25 of 26 subjects (96.15%) displayed ≥1 grade improvement on the temporal volume scale. Subject satisfaction was high, with 91.3% of subjects being satisfied with the appearance of their temporal regions following optimal correction. CONCLUSION: In this pivotal trial, HA-V was evidenced to have an excellent safety profile and proven efficacy up to 16 weeks, making it a suitable HA filler for volumization of the temporal region.


Subject(s)
Cosmetic Techniques , Dermal Fillers , Skin Aging , Female , Humans , Cosmetic Techniques/adverse effects , Follow-Up Studies , Hyaluronic Acid , Patient Satisfaction , Prospective Studies , Treatment Outcome
5.
J Cosmet Dermatol ; 22(9): 2382-2390, 2023 Sep.
Article in English | MEDLINE | ID: mdl-37424173

ABSTRACT

BACKGROUND: Hollowing of the infraorbital region represents a common concern among aesthetic patients. In the past decade, an increasing number of patients have resorted to noninvasive aesthetic procedures to treat these concerns. The objective of this study was to evaluate the safety profile of infraorbital hyaluronic acid injections for aesthetic rejuvenation. METHODS: Through a systematic review and meta-analysis of prospective clinical trials, investigators sought to answer the research question "Does the use of needle versus cannula during infraorbital HA injections result in the same incidence rate of adverse events?" The primary outcomes of interest were the incidence rates of ecchymosis and edema in subject groups treated with a needle or cannula. RESULTS: Subjects treated with needles had a statistically significant greater incidence rate of ecchymosis, compared to those treated with cannula. Conversely, subjects treated with cannula had a statistically significant greater incidence rate of edema, compared to those treated with needles. CONCLUSIONS: The incidence rates of adverse events following the administration of hyaluronic acid injections in the infraorbital region vary depending on whether a needle or cannula is used; with needles being associated with a greater risk of ecchymosis and cannulas being associated with a greater risk of edema. These findings should be discussed with patients prior to treatment consultation. Finally, as with most techniques, it is usually prudent to develop expertise with one technique before using a second, especially in cases where both approaches can be used and have different adverse event profiles.


Subject(s)
Contusions , Cosmetic Techniques , Dermal Fillers , Skin Aging , Humans , Hyaluronic Acid/adverse effects , Dermal Fillers/adverse effects , Cosmetic Techniques/adverse effects , Ecchymosis/chemically induced , Ecchymosis/epidemiology , Prospective Studies , Contusions/etiology , Edema/chemically induced , Edema/epidemiology
6.
Plast Reconstr Surg ; 152(5): 808e-816e, 2023 11 01.
Article in English | MEDLINE | ID: mdl-36912918

ABSTRACT

BACKGROUND: Complex anatomical changes have been the main challenges for optimal treatment results of tear trough deformities through hyaluronic acid (HA) injections. The authors present a novel technique consisting of a preinjection tear trough ligament stretching (TTLS-I) leading to its release, and compared its efficacy, safety, and patient satisfaction to tear trough deformity injection (TTDI). METHODS: This was a 4-year, retrospective, single-center cohort study of 83 TTLS-I patients, with a follow-up period of 1 year. One hundred thirty-five TTDI patients served as a comparison group. Outcome analyses included the analysis of possible risk factors for adverse outcome and comparative statistics between the complication and satisfaction rates of the two groups. RESULTS: TTLS-I patients received significantly less HA (0.3 cc; range, 0.2 to 0.3 cc) than TTDI patients did (0.6 cc; range, 0.6 to 0.8 cc; P < 0.001). The injected HA amount was a significant predictive factor for complications ( P < 0.05). Complication rates assessed during the follow-up visit for hematomas, edema, and the need for corrective hyaluronidase injection were low in both groups, with no significant differences between the groups. TTDI patients had significantly higher rates (5.1%) of lump surface irregularities during follow-up, compared with 0% in the TTLS-I group ( P < 0.05). After 1 year of follow-up, 98.8% of TTLS-I patients were satisfied, whereas 95.6% of TTDI patients were satisfied, with no significant difference between groups. CONCLUSIONS: TTLS-I is a novel, safe, and effective treatment method, necessitating significantly less HA compared with TTDI. Moreover, it leads to very high satisfaction rates and very low complication rates. CLINICAL QUESTION/LEVEL OF EVIDENCE: Therapeutic, III.


Subject(s)
Hyaluronic Acid , Ligaments , Humans , Cohort Studies , Retrospective Studies , Treatment Outcome , Clinical Protocols
7.
J Clin Aesthet Dermatol ; 15(8): E61-E66, 2022 Aug.
Article in English | MEDLINE | ID: mdl-36061478

ABSTRACT

Objective: We sought to evaluate the impact of the coronavirus-19 (COVID-19) pandemic on sun-seeking and sun-safe behaviors. Methods: We conducted an online, cross-sectional, population-based survey. Results: In total, 1,001 respondents participated in the survey and reported being exposed to 12 or more hours of sunlight (i.e., direct and indirect ultraviolet light, and blue light) each day. Participants self-reported a net increase in all types of light exposure since the onset of the COVID-19 pandemic, especially to blue light (+38%). Notably, while the effects of direct sunlight were well known among survey respondents, they were less aware of the potential damaging impact of indirect sunlight and blue light. Limitations: As the survey was only conducted among residents of the United States, results might not be generalizable to all geographical regions. Conclusion: Social outreach strategies are required to improve sun-safe behaviors. Future behavioral interventions should encourage the implementation of broad-spectrum sun protection.

8.
J Drugs Dermatol ; 21(4): s3-s10, 2022 Apr 01.
Article in English | MEDLINE | ID: mdl-35389591

ABSTRACT

BACKGROUND: The term "exposome" describes the totality of exposures an individual is subjected to from conception to death. Both internal and external exposome factors affect skin health. External exposures that contribute to facial skin aging include solar radiation, air pollution, tobacco smoke, and unbalanced nutrition. The review explores scientific and clinical insights into the exposome impact on facial skin aging and topical mineralizing volcanic water use potential benefits. METHODS: An expert panel of seven dermatologists and two clinical researchers specializing in aesthetic and dermatological indications reviewed and discussed the literature on the exposome and mineralizing volcanic water's role in relation to the exposome. Two virtual advisory boards were conducted between February and May 2021. Following the meetings, an additional systematic literature review explored publications relevant to the exposome, topical essential minerals, and skin health. The results of the two advisory boards, coupled with expert opinion and the outcome of the updated systematic literature review, informed the statements on which the advisors reached a consensus. CONCLUSIONS: A combination of in vivo, in vitro, and clinical data on topical mineralizing volcanic water application indicates that the serum supports the skin's antioxidant defenses and reduces skin inflammation. Additionally, the serum may have benefits as an adjunct for facial dermatoses and post-procedural skincare. J Drugs Dermatol. 2022;21:4(Suppl 1):s3-10.


Subject(s)
Exposome , Skin Aging , Environmental Exposure , Face , Humans , Skin , Water
9.
J Drugs Dermatol ; 21(3): 304-308, 2022 03 01.
Article in English | MEDLINE | ID: mdl-35254764

ABSTRACT

BACKGROUND: There is a significant emphasis on minimally invasive whole-body rejuvenation throughout the world. Recently, gluteal aesthetics have become an increasingly common patient concern. Although the application of poly-L-lactic acid (PLLA) to the face is already well known, there are relatively fewer publications on its use in other corporeal regions. This study aims to extend previous findings by evaluating the efficacy and safety of PLLA in the treatment of contour (including lifting) deformities of the buttock region. METHODS: This was a prospective, multicenter (3 sites), single cohort, open-label clinical trial. Thirty female subjects were treated with PLLA in the bilateral buttocks, with three treatment sessions, each spaced one month apart and followed for six months after completion of the treatment regimen. At each visit, various safety and clinical efficacy parameters were collected, these included: Global Assessment of Improvement Scale (GAIS), subject satisfaction, skin hydration, elasticity, scaliness, roughness, and 3-dimensional imagery. RESULTS: Six months following the last treatment, 84.00% of patients were rated as having “improved” or more on the physician assessed GAIS, accompanied by a 96.00% patient satisfaction rate. Approximately three vials of PLLA, per buttock and treatment were used. There were no serious adverse events throughout the duration of the trial, nor adverse events related to the investigational device. The most common subject-reported adverse events included pain during treatment (Mean: 70.97%) and bruising (Mean: 28.80%). Objective improvements were persistent after treatment in measurements of skin elasticity (improved 63.5% - 82.5% from weeks 16-32), hydration (increased ~11 Corneometer® units by week 16), roughness (decreased 36.95% at week 32), and scaliness (desquamation; decreased 60.41% at week 32). CONCLUSIONS: PLLA is safe and effective for the indication of buttock contouring and improving parameters of skin health. PLLA can provide long-lasting effects with a high level of patient and physician satisfaction. J Drugs Dermatol. 2022;21(3):304-308. doi:10.36849/JDD.5924.


Subject(s)
Cosmetic Techniques , Skin Aging , Buttocks , Cosmetic Techniques/adverse effects , Female , Humans , Patient Satisfaction , Polyesters/adverse effects , Prospective Studies , Treatment Outcome
10.
Aesthet Surg J ; 42(3): 285-297, 2022 Feb 15.
Article in English | MEDLINE | ID: mdl-34282831

ABSTRACT

BACKGROUND: Periorbital deformities can be corrected utilizing hyaluronic acid injections. However, previous studies have not evaluated the effect of utilizing different injection techniques (eg, a needle vs cannula) on efficacy and safety. OBJECTIVES: The authors sought to investigate the efficacy and safety of HA for the correction of periorbital deformities when utilizing either needle or cannula-assisted injections. METHODS: This was a prospective, randomized-controlled (with crossover), evaluator-blinded study. Forty-two patients with a mean age of 44.82 ± 11.62 years were recruited. Patients underwent 2 treatment sessions, spaced 2 weeks apart, and attended 1 follow-up visit at Week 4, following the last treatment. Patients were randomized in a 3:3:1 ratio, whereby 18 patients received injections by needle, 18 received injections by cannula, and 6 were randomized to act as their own control at baseline. Those in the control group were randomized (n = 3) to needle or cannula injections at Week 4 and proceeded with the same visit schedule as those treated at baseline. At Weeks 2 and 4 posttreatment, patient satisfaction was evaluated and information on adverse effects was collected. A blinded reviewer assessed patient imagery utilizing standardized efficacy scales. RESULTS: Chi-square tests did not reveal any associations between treatment group and efficacy, safety, or patient satisfaction scores (P ≥ 0.05). Adverse effects reported in patient diaries were mild to moderate in nature and expected. CONCLUSIONS: For the treatment of infraorbital deformities, hyaluronic acid injections performed utilizing either a cannula or needle result in similarly high efficacy and safety ratios.


Subject(s)
Cannula , Hyaluronic Acid , Adult , Cannula/adverse effects , Humans , Hyaluronic Acid/adverse effects , Middle Aged , Needles , Prospective Studies , Treatment Outcome
11.
J Cosmet Dermatol ; 21(2): 608-614, 2022 Feb.
Article in English | MEDLINE | ID: mdl-34921494

ABSTRACT

BACKGROUND: Several studies have started investigating the safety of temporal rejuvenation using soft tissue fillers. However, as the temporal region is highly vascularized, adverse events due to intravascular injection are of primary concern. The scarcity of treatment guidelines to date have focused primarily on avoiding the superficial and middle temporal arteries. The aim of the present anatomical study was to describe the topography of the deep temporal arteries (DTAs) with reference to superficial landmarks, to aid clinicians who perform temporal injections. METHODS: The tissue layers of eight fresh-frozen cephalic cadavers were dissected and assessed, bilaterally in the temporal region (N = 16). Distance (D) of the anterior (D1 and D3) and posterior (D2 and D4) arteries was measured from (i) the zygomaticofrontal suture line at the lateral orbital rim (D1 and D2) and (ii) the junction of the superior border of the zygomatic arch and lateral orbital rim (D3 and D4). The distance between the anterior and posterior DTAs was also recorded, at the two regions (D5). RESULTS: Bifurcations of the DTAs were observed in 18.75% (3/16) and 12.5% (2/16) of cases, for the anterior and posterior branches, respectively. On average [mean (standard deviation)], D1 (anterior DTA to the zygomaticofrontal suture line at the lateral orbital rim) = 1.56 cm (0.59); D2 (posterior DTA to the zygomaticofrontal suture line at the lateral orbital rim) = 2.98 cm (0.70); D3 (anterior DTA to the junction of the superior border of the zygomatic arch and lateral orbital rim) = 1.14 cm (0.63); D4 (posterior DTA to the junction of the superior border of the zygomatic arch and lateral orbital rim) = 2.37 cm (0.62); and D5 (distance between the anterior and posterior DTAs) = 1.54 cm (0.68). CONCLUSION: To help avoid vascular adverse events while performing temporal injections, aesthetic clinicians should be conscientious of safety implications related to the anatomical location of the DTAs and their ramifications.


Subject(s)
Temporal Arteries , Zygoma , Cadaver , Esthetics , Humans , Rejuvenation
12.
J Cosmet Dermatol ; 20(12): 3974-3981, 2021 Dec.
Article in English | MEDLINE | ID: mdl-34741580

ABSTRACT

INTRODUCTION: A challenge of minimally invasive esthetic procedures (eg, injectables and threads) is managing adverse events (AEs), such as post-procedural bruising. Implementation of post-procedural camouflage therapy may minimize the appearance of bruising and mitigate AEs. AIMS: A physician and patient user experience program was designed to evaluate the safety and efficacy of a concealer for the cosmetic camouflage of post-procedural bruising. METHODS: Thirty female patients with a mean age of 42.03 years participated in the program. Physicians and patients completed various questionnaires regarding the safety and efficacy of the investigational product (Dermablend™ Professional Cover Care Full Coverage Concealer) at three timepoints: Visit 1 (Day 0); Visit 2 (Day 3); and Visit 3 (Day 14 ± 3 days). RESULTS: All patients presented with mild-to-moderate bruising following treatment with either esthetic injectables or threads. On average, users required 1.55 (SD: 0.72) coats to sufficiently cover their bruise(s). After application of the concealer, 78.18% of users displayed "clear skin with no signs of erythema" and 21.82% displayed "almost clear skin, with slight redness." No physician-reported AEs related to product use were reported throughout the evaluation period. No allergic reactions upon application nor intolerance to the product after prolonged use (ie, up to 14 days ± 3 days) was observed. Throughout the duration of use, 98.81% of subjects were at least slightly satisfied with results. At Visits 1 and 2, 100% of physicians were at least slightly satisfied with results. CONCLUSION: Cosmetic concealer use can ameliorate the post-procedural experience for patients presenting with mild-to-moderate bruising.


Subject(s)
Contusions , Skin Aging , Adult , Contusions/etiology , Erythema , Esthetics , Female , Humans , Injections
13.
Clin Cosmet Investig Dermatol ; 14: 615-622, 2021.
Article in English | MEDLINE | ID: mdl-34140793

ABSTRACT

BACKGROUND AND OBJECTIVE: Poly-L-lactic acid (PLLA) has been used in various medical applications for decades, including aesthetic ones. The use of a cannula technique in injecting PLLA has been proposed in order to lower the incidence rate of adverse events (AEs) following treatment. Such AEs include nodule formation, which may occur less frequently by fanning the product with a cannula, thus creating a more uniform product placement compared to that resulting from the use of a needle. Currently, however, there is a lack of comparative research regarding the safety of cannulas versus needles for PLLA injections, as the selection of either remains highly subjective. Therefore, the objective of our study was to investigate the safety of cannula use in the administration of PLLA, in order to report safety outcomes. MATERIALS AND METHODS: A single-center, retrospective chart review was conducted to examine the data of patients who had previously undergone treatment with PLLA in the form of Sculptra® Aesthetic™ in the face and/or neck regions. Twenty-seven subject charts met eligibility. Descriptive data regarding treatment and follow-up visits were collected and analyzed. RESULTS: A total of seven AEs resulted from eighty-two treatment sessions (8.54%), with 6/27 patients having experienced at least one AE (22.22%). Mild bruising was the most commonly reported AE (57.14%). The majority of the AEs were mild and transient in nature, with one moderate AE being a nodule that was possibly related to a concomitant treatment. All AEs were resolved with follow-up care. CONCLUSION: Mild AEs such as bruising, swelling and pain should be expected following the use of a cannula for PLLA injections. However, the incidence rates of AEs following treatment can remain low if proper product preparation and treatment techniques are utilized.

14.
J Cosmet Dermatol ; 20(7): 2096-2101, 2021 Jul.
Article in English | MEDLINE | ID: mdl-33960109

ABSTRACT

BACKGROUND: In 2018, the first device to use high-intensity focused electromagnetic (HIFEM) technology to non-invasively build muscle was brought to market. Even more recently, the first HIFEM and radiofrequency combination device designed to both build muscle and eliminate fat cells came into use (HIFEM+). In view of the increase in recently published original data pertaining to HIFEM, an advisory board recently convened to discuss the group's clinical experiences with this technology. AIM: Communicate an advisory group's recommendations for the current use of HIFEM+ technology for aesthetic indications. METHODS: An advisory board meeting to discuss challenges and opportunities for HIFEM devices in aesthetic medicine took place in November 2020, via remote conference. The expert advisory board consisted of a group of senior aesthetic physicians regularly treating patients with non-invasive body contouring devices. A narrative review of the literature and key recommendations from the meeting are presented herein. RESULTS: To date, the combined results of several clinical studies (including over 500 patients and 30 investigators) support that patients treated with HIFEM+ experience on average, 30% less fat, 25% more muscle, 19% reduction in abdominal separation and up to 5.9 cm reduction in waist circumference. Moreover, HIFEM+ induces a 30% increase in satellite cell content, which is similar to the 36% increase observed following twelve weeks of exercise. CONCLUSIONS: The advisory board unanimously agreed on several messages related to HIFEM technology, including that the pairing of HIFEM and radiofrequency (HIFEM+) enables a higher intensity of muscle stimulation and lipolysis, compared to HIFEM alone.


Subject(s)
Body Contouring , Lipolysis , Esthetics , Humans , Radio Waves , Waist Circumference
15.
J Cosmet Dermatol ; 20(5): 1450-1458, 2021 May.
Article in English | MEDLINE | ID: mdl-32779375

ABSTRACT

BACKGROUND: Injections of hyaluronic acid (HA) for tissue augmentation are one of the most common aesthetic treatments performed worldwide. However, few studies have compared the safety and efficacy of small- and large-particle HA (SP-HA; LP-HA). AIM: To assess and compare the safety and efficacy of SP-HA and LP-HA for the correction of nasolabial folds (NLFs). METHODS: A prospective, split-face, triple-blind study design was used. Ten female subjects were recruited. Patients underwent treatment at baseline, an optional touch up at Week 2, and a follow-up visit at Week 4. At weeks 2 and 4, a blinded reviewer assessed the patients using the Global Aesthetic Improvement Scale (GAIS) and Wrinkle Severity Rating Scale (WSRS); and subjects completed the Patient Satisfaction Questionnaire (PSQ). At all visits, 3-dimensional imagery and ultrasonography of patients' NLFs were captured. Adverse events (AEs) were evaluated by the Investigator and recorded by subjects in diaries. RESULTS: The GAIS response rate, defined as ≥ "improved" from baseline, was between 90 (2 weeks) and 100% (1 month) for SP-HA and was 100% for LP-HA, at both visits. Paired-samples t tests revealed significant differences in the change in WSRS scores between groups, at both visits (P < .01). Differences in the clinical effect and lifting capacity of both products were observed in 3-dimensional imagery and ultrasonography. Treatment volumes varied, with 61.32% more SP-HA being required than LP-HA for achieving a ≥ one-grade WSRS improvement. There were no severe AEs throughout the trial, nor AEs related to the investigational device. CONCLUSIONS: LP-HA demonstrates better efficacy for correcting bony resorption in the nasal pyriform region.


Subject(s)
Cosmetic Techniques , Dermal Fillers , Skin Aging , Cosmetic Techniques/adverse effects , Dermal Fillers/adverse effects , Double-Blind Method , Female , Humans , Hyaluronic Acid/adverse effects , Nasolabial Fold , Prospective Studies , Treatment Outcome
16.
J Dermatolog Treat ; 32(5): 538-543, 2021 Aug.
Article in English | MEDLINE | ID: mdl-31621451

ABSTRACT

INTRODUCTION: This is the first study to evaluate Health Canada's national reporting database, MedEffect™, to assess the safety and efficacy of esthetic injectables. OBJECTIVE: Describe adverse reactions (ARs) associated with soft tissue fillers and neurotoxins. METHODS: Investigators reviewed MedEffect™ for reports associated with esthetic injectables from January 1 1965 to March 31 2018. Descriptive analyses of the reports were completed, including information on reporters', patients', and AR characteristics. RESULTS: A total of 1459 individual reports containing 5714 ARs were evaluated. The majority (n = 5705; 99.84%) of reported ARs were related to neurotoxins and only 0.16% (n = 9) were related to soft tissue fillers. Most reports were submitted by health professionals (n = 4930; 86%), indicated that the product was ineffective (n = 2428; 42.5%) and that the result of ARs were unknown (n = 4835; 84.6%). CONCLUSIONS: ARs associated with the use of neurotoxins and soft tissue fillers are underreported in Canada. More complete and representative information regarding ARs is necessary for the development and validation of treatment algorithms and management strategies.


Subject(s)
Neurotoxins/adverse effects , Adult , Canada , Databases, Factual , Esthetics , Female , Humans , Injections , Male , Middle Aged , Neurotoxins/administration & dosage , Retrospective Studies
17.
Aesthet Surg J ; 41(8): 932-941, 2021 07 14.
Article in English | MEDLINE | ID: mdl-33216910

ABSTRACT

BACKGROUND: Paradoxical adipose hyperplasia (PAH) is a rare, moderate-to-severe adverse event associated with cryolipolysis (CoolSculpting, CS). OBJECTIVES: The aim of this study was to describe the incidence, diagnosis, and treatment of PAH occurring after CS for nonsurgical fat reduction. METHODS: A multicenter evaluation of all patients who underwent CS treatment between January 2015 and December 2019 at 8 Canadian medical centers was conducted. Data abstracted included symptoms, management strategy, outcome, operator characteristics, device characteristics, patient characteristics, body region, and CS treatment details. Incidence of PAH was calculated based on the number of treatment cycles. RESULTS: Our findings revealed incidence rates between 0.05% and 0.39%, which are slightly higher than the manufacturer's quoted rate of 0.025% (1 per 4000 cycles). Incidence rates at all sites were dramatically reduced by over 75% with the implementation of newer models of CS units. Of patients who developed PAH, 55% were male and 77.8% were of European ethnic origin. The majority of cases (76.9%) were associated with older models of CS units. CONCLUSIONS: Development of PAH may be related to a combination of factors, including older models of CS units and applicators, as well as individual characteristics that predispose certain patients.


Subject(s)
Body Contouring , Lipectomy , Body Contouring/adverse effects , Canada/epidemiology , Humans , Hyperplasia/pathology , Lipectomy/adverse effects , Male , Multicenter Studies as Topic , Subcutaneous Fat/surgery
18.
J Cosmet Dermatol ; 19(6): 1294-1300, 2020 Jun.
Article in English | MEDLINE | ID: mdl-32338450

ABSTRACT

BACKGROUND: Treating the lower face with neuromodulators and targeting the masseter muscle can reduce masseteric hypertrophy but can also change the facial shape. A novel observation after the treatment of the masseter muscle with incobotulinumtoxin Type A was the increase in temporal volume. AIM: Objectively assess temporal volume increase following treatment of masseteric hypertrophy using incobotulinumtoxin Type A. METHODS: Nine female patients with a mean age of 35.11 years ± 9.1 [Asian (11.1%) and Caucasian (88.9%)] were treated with incobotulinumtoxin Type A for masseteric hypertrophy. Masseteric prominence and temporal volume were assessed by two independent raters, and temporal fossa volume was measured via 3-dimensional volumetric imaging. RESULTS: Independent of the neuromodulator injection technique (ie, single-injection versus multi-injection), a reduction in masseteric hypertrophy occurred represented by a decrease in the masseter prominence scale. In addition, the treatment resulted in a significant improvement of the temporal volume scale and an increase in the measured volume of the temporal fossa. None of the presented measurements were statistically significantly different between the two utilized injection techniques. CONCLUSIONS: This study supports using a full-face approach when performing aesthetic treatments. Anatomical concepts can help to guide treatments: the compensatory increase in temporalis function after masseter muscle treatment resulted in an increased in temporal fossa volume. The findings presented herein should not be considered as a new concept for treating the temporal fossa but rather as an additional possibility for increasing the temporal volume.


Subject(s)
Botulinum Toxins, Type A/administration & dosage , Cosmetic Techniques , Forehead/anatomy & histology , Hypertrophy/drug therapy , Masseter Muscle/abnormalities , Neuromuscular Agents/administration & dosage , Adult , Female , Follow-Up Studies , Forehead/diagnostic imaging , Humans , Imaging, Three-Dimensional , Injections, Intramuscular , Treatment Outcome
19.
Aesthet Surg J Open Forum ; 2(1): ojaa005, 2020 Jan.
Article in English | MEDLINE | ID: mdl-33791625

ABSTRACT

BACKGROUND: Aesthetic physicians have several hundred injectable products to select from. Due to differences in their manufacturing technology, these products display varying biophysical qualities, such as their cohesivity and lift capacity. Currently, there is no guidance to objectively selecting the best product for a particular patient. Therefore, an algorithmic approach is required to take specific skin characteristics into consideration. OBJECTIVES: To evaluate (1) whether subjects seeking injectable treatments for midfacial volume loss and/or contour deficiency can be stratified based on specific skin characteristics (eg, thickness, fat quantity, bony structure) and (2) whether particular hyaluronic acid fillers perform best when used in such particular strata. METHODS: This was a prospective, Phase IV, open-label, single-center clinical trial. Thirty female patients with midface/cheek volume loss and/or contour deficiency were recruited (mean age, 53.5 years; SD, 12.57; range, 35-75 years). Subjects were treated with either Restylane Lyft (HAL) or Restylane Volyme (HAV) and followed for 4 months post-injection. Treatment allocation was based on the treating physician's clinical evaluation and compared with ultrasound evaluation. Ultrasound images were used to confirm stratification. Safety and efficacy assessments were performed at each study visit: baseline, week 2, week 4, week 8, and week 16. Subgroup analyses evaluated whether particular strata performed best when treated with specific products. RESULTS: The 2 investigative products varied in their efficacy, depending on the characteristics of the subject. CONCLUSIONS: The use of a treatment algorithm may improve outcomes for patients seeking injectable treatments for midfacial volume loss and contour deficiencies.

20.
J Cosmet Dermatol ; 19(1): 61-68, 2020 Jan.
Article in English | MEDLINE | ID: mdl-31106967

ABSTRACT

BACKGROUND: Findings indicate that standard injection techniques for hyaluronic acid (HA) soft tissue fillers result in considerable variations in the applied boluses. Furthermore, despite the knowledge that the varying biophysical properties of HA fillers (eg, G', cohesivity, viscoelasticity) can affect their ease of injection, the impact of device attributes on an injector's volumetric accuracy is currently unknown. OBJECTIVES: (a) Evaluate the ability of aesthetic physicians to accurately inject a specific amount of HA filler; (b) investigate the effect of physician experience on injection accuracy; and (c) investigate the impact of different HA gel properties on an injector's performance. METHODS: Thirteen physicians with aesthetic experience were recruited. Subjects were blindfolded and asked to deposit 0.2 cc of four HA fillers under two conditions: (a) onto a scale and (b) into a porcine membrane. The amount of gel deposited/injected was then measured. An accurate injection was defined as 0.2 cc ± 15%. RESULTS: Subjects were rarely able to dispense accurate amounts of injectate (42/208 injections or 20.19%) and often underestimated their injection quantities. Variations in the accuracy distributions between groups were observed. An injector's experience, the conditions under which injections were performed and the product choice were all variables found to affect the accuracy distributions. CONCLUSIONS: The findings of this study provide evidence that the use of visual and/or audible stimuli is necessary for dispensing accurate volumes. This has clinical implications for treatment efficacy and patient satisfaction during free hand injections. To ensure more accurate and reproducible results, the investigators propose a possible modification to the standard injection technique.


Subject(s)
Cosmetic Techniques , Dermal Fillers/administration & dosage , Hyaluronic Acid/administration & dosage , Injections, Subcutaneous/methods , Animals , Dermal Fillers/chemistry , Dermatologists , Dose-Response Relationship, Drug , Elasticity , Gels , Humans , Hyaluronic Acid/chemistry , Patient Satisfaction , Proof of Concept Study , Prospective Studies , Skin , Surgeons , Swine , Treatment Outcome , Viscosity
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