Publications by authors named "Tatjana Pavicic"

52 Publications

Intraarterial Degradation of Calcium Hydroxylapatite Using Sodium Thiosulfate - An In Vitro and Cadaveric Study.

Aesthet Surg J 2021 Apr;41(5):NP226-NP236

Department of Clinical Anatomy, Mayo Clinic College of Medicine and Science, Rochester, MN, USA.

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.
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http://dx.doi.org/10.1093/asj/sjaa350DOI Listing
April 2021

To click or not to click - The importance of understanding the layers of the forehead when injecting neuromodulators - A clinical, prospective, interventional, split-face study.

J Cosmet Dermatol 2020 Nov 30. Epub 2020 Nov 30.

Department of Clinical Anatomy, Mayo Clinic College of Medicine and Science, Rochester, MN, USA.

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/m . 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.
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http://dx.doi.org/10.1111/jocd.13875DOI Listing
November 2020

Delayed Inflammatory Reactions to Hyaluronic Acid Fillers: A Literature Review and Proposed Treatment Algorithm.

Clin Cosmet Investig Dermatol 2020 18;13:371-378. Epub 2020 May 18.

Department of Dermatology, Tel Aviv Sourasky Medical Center, Tel Aviv, Israel.

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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http://dx.doi.org/10.2147/CCID.S247171DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7244356PMC
May 2020

Safety, Tolerability, and Efficacy of Repeat-Dose Injections of IncobotulinumtoxinA in the Treatment of Upper Facial Lines: Results from a Prospective, Open-Label, Phase III Study.

J Drugs Dermatol 2020 May;19(5):461-469

In aesthetic practice, wrinkles in the upper face are commonly treated with repeat-dose injections. The objective of this study was to investigate the safety, tolerability, and efficacy of repeat-dose injections of incobotulinumtoxinA in the combined treatment of moder-ate to severe upper facial lines (UFL) [glabellar frown lines (GFL), horizontal forehead lines (HFL), and lateral periorbital lines (LPL)]. Healthy subjects (≥18 years) with moderate to severe GFL, HFL, and LPL on the Merz Aesthetics Scales (MAS) at maximum contrac-tion were administered 54 to 64 U of incobotulinumtoxinA (GFL, 20 U; HFL, 10 to 20 U; LPL, 24 U) in up to four, 120-day treatment cycles. Adverse events (AE) were recorded for each cycle until 120 ± 7 days after treatment. Investigator-assessed MAS scores were evaluated for each treated area at maximum contraction on day 30 [responder = score of “none” (0) or “mild” (1)]. Subject-assessed scores for overall appearance of the upper face of “much improved” or “very much improved” were noted at day 30 of each treatment cycle on the Global Impression of Change Scale (GICS). Overall, 140 subjects were treated, and 125 subjects completed the study. Mean injected units per injection cycle ranged from 56.3 U to 57.7 U. During the four-cycle study period 17.1% of total treated subjects experienced a treatment emergent adverse event (TEAE). TEAEs of special interest were documented for 9 subjects (6.4%), in 6 of these subjects (4.3%) the TEAEs were related to treatment. No clinically significant mean changes in laboratory and vital-sign values were observed from screening to final-treatment visit. Over the study interval, a response rate of > 80% on the investigator-assessed MAS was reported for all treated areas except HFL. Greater than 80% of subjects in cycles 1, 3, and 4 and 78.5% of subjects in cycle 2 reported ratings of “much improved” or “very much improved” on the GICS for the overall appearance of the upper face. Incobotu-linumtoxinA for the repeat-dose treatment of UFL is safe and well tolerated with a stable safety profile, without new formation of neutralizing antibodies and has excellent efficacy during prolonged administration. J Drugs Dermatol. 2020;19(5):461-469. doi:10.36849/JDD.2020.5013.
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May 2020

The six different injection techniques for the temple relevant for soft tissue filler augmentation procedures - Clinical anatomy and danger zones.

J Cosmet Dermatol 2020 Jul 1;19(7):1570-1579. Epub 2020 Jun 1.

Department for Hand, Plastic and Aesthetic Surgery, Ludwig - Maximilian University Munich, Munich, Germany.

Objective: The most promising facial region for inducing pan-facial effects is the temporal region. The temple displays signs of facial aging itself which include temporal volume loss and increased visibility of the temporal crest, the temporal vasculature, the lateral orbital rim, and the upper zygomatic arch. The objective of this article is to provide a detailed review of temple anatomy pertaining to routinely performed temporal injection techniques, their expected esthetic outcomes as well as the intendant advantages, disadvantages, and procedure pearls.

Materials And Methods: This narrative review is based on the clinical experience of the authors treating the temporal region for esthetic purposes. The postulated outcome of each technique was observed during the routine clinical practice of the authors.

Results: The temporal region is based on a bony platform consisting of the parietal, frontal, sphenoid, and temporal bones. The overlying soft tissues are arranged in layers which contain the temporal neurovascular structures. The temporal soft tissues consist of 10 parallel layers which vary in their thickness depending on age-related influences. Six different techniques will be addressed, which include subdermal and interfascial techniques for volumizing, low and high supraperiosteal techniques for volumizing, and supraauricular and temporal lifting techniques.

Conclusion: This narrative provides a detailed anatomic overview of the temporal region and describes each commonly performed injection technique with respect to anatomy, esthetic outcome, as well as potential pearls and pitfalls. It is hoped that the description contained herein may guide esthetic practitioners toward safer and more natural outcomes when treating the face.
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http://dx.doi.org/10.1111/jocd.13491DOI Listing
July 2020

The Bidirectional Movement of the Frontalis Muscle: Introducing the Line of Convergence and Its Potential Clinical Relevance.

Plast Reconstr Surg 2020 05;145(5):1155-1162

From the Division of Anatomy, Department of Medical Education, Albany Medical College; the Division of Plastic Surgery, Department of Surgery, Albany Medical Centre; the Department for Hand, Plastic and Aesthetic Surgery, Ludwig Maximilian University of Munich; Rosenpark Klinik; Wolfson Medical Center, Dermatology; private practice; Cosmetic Laser Dermatology; Mayo Clinic College of Medicine and Science, Mayo Clinic; and Skin Associates of South Florida.

Background: Cosmetic treatment of the forehead using neuromodulators is challenging. To avoid adverse events, the underlying anatomy has to be understood and thoughtfully targeted. Clinical observations indicate that eyebrow ptosis can be avoided if neuromodulators are injected in the upper forehead, despite the frontalis muscle being the primary elevator.

Methods: Twenty-seven healthy volunteers (11 men and 16 women) with a mean age of 37.5 ± 13.7 years (range, 22 to 73 years) and of diverse ethnicity (14 Caucasians, four African Americans, three Asians, and six of Middle Eastern descent) were enrolled. Skin displacement vector analyses were conducted on maximal frontalis muscle contraction to calculate magnitude and direction of forehead skin movement.

Results: In 100 percent of investigated volunteers, a bidirectional movement of the forehead skin was observed: the skin of the lower forehead moved cranially, whereas the skin of the upper forehead moved caudally. Both movements converged at a horizontal forehead line termed the line of convergence, or C-line. The position of the C-line relative to the total height of the forehead was 60.9 ± 10.2 percent in men and 60.6 ± 9.6 percent in women (p = 0.941). Independent of sex, the C-line was located at the second horizontal forehead line when counting from superior to inferior (men, n = 2; women, n = 2). No difference across ethnicities was detected.

Conclusions: The identification of the C-line may potentially guide practitioners toward more predictable outcomes for forehead neuromodulator injections. Injections above the C-line could mitigate the risk of neuromodulator-induced brow ptosis.
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http://dx.doi.org/10.1097/PRS.0000000000006756DOI Listing
May 2020

Managing intravascular complications following treatment with calcium hydroxylapatite: An expert consensus.

J Cosmet Dermatol 2020 Nov 17;19(11):2845-2858. Epub 2020 Mar 17.

Falck Clinic, Aesthetic Medicine Centre, Amsterdam, The Netherlands.

Background: Inadvertent intra-arterial injection of dermal fillers including calcium hydroxylapatite (CaHA) can result in serious adverse events including soft tissue necrosis, permanent scarring, visual impairment, and blindness. When intra-arterial injection occurs, immediate action is required for optimal outcomes, but the infrequency of this event means that many physicians may never have experienced this scenario. The aim of this document is to provide evidence-based and expert opinion recommendations for the recognition and management of vascular compromise following inadvertent injection of CaHA.

Methods: An international group of experts with experience in injection of CaHA and management of vascular complications was convened to develop a consensus on the optimal management of vascular compromise following intra-arterial CaHA injection. The consensus members were asked to provide preventative advice for the avoidance of intravascular injection and to produce a treatment protocol for acute and delayed presentation. To ensure all relevant treatment options were included, the recommendations were supplemented with a PubMed search of the literature.

Results: For prevention of intra-arterial CaHA injection, consensus members outlined the importance of a thorough knowledge of facial vascular anatomy and patient history, as well as highlighting potential risk zones and optimal injection techniques. Individual sections document how to recognize the symptoms of vascular occlusion leading to vision loss and tissue necrosis as well as detailed treatment protocols for the management of these events. For impending tissue necrosis, recommendations are provided for early and delayed presentations with treatment protocols for acute and follow-up treatment. A separate section details the treatment options for open and closed wounds.

Conclusions: All physicians should be prepared for the eventuality of intra-arterial injection of a dermal filler, despite its rarity. These consensus recommendations combine advice from aesthetic experts with the latest reports from the published literature to provide an up-to-date office-based protocol for the prevention and treatment of complications arising from intra-arterial CaHA injection.
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http://dx.doi.org/10.1111/jocd.13353DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7687073PMC
November 2020

Soft tissue distribution pattern of facial soft tissue fillers with different viscoelastic properties.

J Cosmet Dermatol 2020 Feb 10;19(2):312-320. Epub 2020 Jan 10.

Division of Anatomy, Department of Medical Education, Albany Medical College, Albany, NY, USA.

Background: Soft tissue filler product distribution and tissue integration have been shown to depend on myriad factors including the injector type, injector size, and injection angle.

Aim: This study aims to investigate the magnitude of product spread across fascial soft tissue layers in relation to product viscoelastic properties.

Patients/methods: A total of 168 injection procedures were conducted in two female Caucasian body donors with a mean age of 80 years (range: 79-81) and a mean body mass index of 23.6 kg/m (range: 21.0-26.6). The injection procedures were performed in the forehead, scalp, zygomatic arch, mandible, clavicle, and sternum. The injected materials included Belotero Soft, Belotero Balance, Belotero Intense, Belotero Volume, Radiesse , and Radiesse Plus. Layer-by-layer dissections were performed to investigate the vertical distribution of the injected product.

Results: The mean product spread was for Belotero Soft 4.54 ± 0.91; Belotero Balance 3.85 ± 1.19; Belotero Intense 3.04 ± 1.34; Belotero Volume 2.58 ± 1.27; Radiesse 1.31 ± 0.47; and Radiesse Plus 1.27 ± 0.45 with P < .001. Bivariate correlations between product spread and storage modulus (G') revealed an inverse relationship of moderate strength with r  = -0.651 and P < .001.

Conclusion: The results of the present study revealed that products that were more fluid and less viscous distributed into more superficial fascial layers than products that were less fluid and more viscous (P < .001). This relationship held true irrespective of injected location.
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http://dx.doi.org/10.1111/jocd.13246DOI Listing
February 2020

A Consensus on Minimizing the Risk of Hyaluronic Acid Embolic Visual Loss and Suggestions for Immediate Bedside Management.

Aesthet Surg J 2020 08;40(9):1009-1021

Department of Plastic Surgery, Fortis Hospital, Mohali, India.

Background: Hyaluronic acid fillers have a satisfactory safety profile. However, adverse reactions do occur, and rarely intravascular injection may lead to blindness. Currently there is no internationally recognized consensus on the prevention or management of blindness from hyaluronic acid filler.

Objectives: The authors sought to give guidance on how to minimize the risk and optimize the management of this rare but catastrophic adverse reaction.

Methods: A multinational group of experts in cosmetic injectables from multiple disciplines convened to review current best practice and develop updated consensus recommendations for prevention and bedside intervention if visual loss occurs after cosmetic injection of hyaluronic acid filler.

Results: The consensus group provided specific recommendations focusing on the consenting process, prevention, and early management of visual impairment related to intravascular hyaluronic acid filler injection.

Conclusions: Although visual loss due to filler injections is rare, it is important that both patient and physician be aware of this risk. In this paper the authors describe methods and techniques available to reduce the risk and also document suggested initial management should a clinician find themselves in this situation.

Level Of Evidence: 5:
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http://dx.doi.org/10.1093/asj/sjz312DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC7427155PMC
August 2020

Subperiosteal injections during facial soft tissue filler injections-Is it possible?

J Cosmet Dermatol 2020 Mar 16;19(3):590-595. Epub 2019 Jul 16.

Department of Medical Education, Albany Medical College, Albany, NY, USA.

Background: It can be hypothesized that safety during soft tissue filler injection could be enhanced if the product could be positioned between the periosteum and the bone surface i.e. subperiosteal.

Aim: This study investigated the feasibilityof subperiosteal injections.

Patients/methods: We analysed 126 injection procedures performed in seven Caucasian body donors (4 males, 3 females) with a mean age of 75.29 ± 4.95 years [range: 70 - 87] and a mean body mass index of 23.53 ± 3.96 kg/m [range: 16.46 - 32.23]. The injection procedures were performed in the forehead, scalp, zygomatic arch and the mandible bilaterally. Injection procedures were conducted using 25G, 27G and 30G sharp-tip needles (TSK Laboratory, Tochigi, Japan) and at various angles from the bone surface measured with a goniometer: 90 degrees (perpendicular), 45 degrees and 10 degrees (as tangential as possible to bone surface).

Results: Cadaveric dissections of the injection sites showed that no product was located deep to the periosteum in any of the investigated regions. This indicates that all performed injection procedures positioned the product superficial to the periosteum (100%) with a zero-success rate of subperiosteal injections.

Conclusion: In the setting of this cadaveric investigation, despite varying needle size and injection angle, subperiosteal injection could not be achieved. This indicates that the product can spread uncontrolled into more superficial layers yielding an increased risk for adverse aesthetic and vascular events.
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http://dx.doi.org/10.1111/jocd.13073DOI Listing
March 2020

Influence of needle size and injection angle on the distribution pattern of facial soft tissue fillers.

J Cosmet Dermatol 2019 Jul 8. Epub 2019 Jul 8.

Division of Anatomy, Department of Medical Education, Albany Medical College, Albany, NY, USA.

Background: Soft tissue filler injections are performed using either sharp-tip needles or blunt-tip cannulas. Product can change planes in an uncontrolled manner during needle injections, potentially leading to unintentional intra-arterial placement. There is a paucity of data on the influence of injection angle on the dispersion patterns of soft tissue fillers.

Materials And Methods: A total of 126 injection procedures were conducted in seven Caucasian body donors (four males, three females) with a mean age of 75.29 ± 4.95 years and a mean body mass index of 23.53 ± 3.96 kg/m . Injection procedures were performed in various facial regions (forehead, scalp, zygomatic arch, mandibular angle), utilizing different needle sizes (25G, 27G, 30G) and different angles (90°, 45°, 10°). Layer-by-layer dissections were performed to verify the location of the injected product. Dissections were facilitated by the colored material.

Results: Utilizing a 30G needle (compared to a 25G needle) reduces the superficial spread with OR 0.70 (95% CI, 0.48-0.99) and P = 0.049, whereas injecting at 90° (vs 10° with the bevel down) increases the odds for superficial spread with OR 10.0 (95% CI, 7.11-14.09) and P < 0.001.

Conclusion: Precision during soft tissue filler injections, defined as the product remaining in the plane of intended implantation, can be enhanced by changing the needle size and the injection angle. Utilizing a 30G needle and injecting at a 10° angle with bevel facing down reduces the uncontrolled product distribution into superficial fascial layers.
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http://dx.doi.org/10.1111/jocd.13066DOI Listing
July 2019

Clinical Validation of the Surface Volume Coefficient for Minimally Invasive Treatment of the Temple

J Drugs Dermatol 2019 Jun;18(6):533

Objective: The aim of the present study is to compare the temporal surface volume coefficient obtained in the cadaveric model from subdermal and supraperiosteal injections to the clinical setting when treating temporal hollowing. Material and Methods: A total of 36 subjects were included in this investigation, 17 patients (16 females, 1 male; 46.3 ± 8.9 years; 25.5 ± 2.8 kg/m2) and 19 cadaveric specimens (11 females, 8 males; 76.4 ± 11.5 years; 24.0 ± 5.1 kg/m2). Subdermal and supraperiosteal injections were performed and live subjects were evaluated and followed for 12 months. The surface volume coefficients were calculated using 3D surface volume scanning and compared for validity. Results: No statistically significant difference was detected between the clinical outcome scores of the subdermal vs supraperiosteal injection technique. The supraperiosteal injection technique utilized significantly more product 1.20 ± 0.5 cc [range: 0.50 – 2.6 cc] compared to the subdermal 0.71 ± 0.2 cc [range: 0.30 – 1.20 cc] vs with P< 0.001. This difference was consistent with the different values of the cadaveric surface volume coefficient (subdermal vs supraperiosteal): 1.00 ± 0.2 vs 0.70 ± 0.2. At 12-month follow-up, the product loss was 19% for the subdermal injection and 21% for patients treated with supraperiosteal injections. Conclusion: The results of the study support the clinical validity of the surface volume coefficient. They demonstrate that the different injection volumes necessary to deliver aesthetically appealing results when utilizing the subdermal vs the supraperiosteal technique can be explained by the region-specific surface volume coefficient. J Drugs Dermatol. 2019;18(6):533-540.
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June 2019

Validation of a Photonumeric Assessment Scale for Grading the Slope of the Asian Forehead.

Dermatol Surg 2019 08;45 Suppl 1:S38-S45

Merz Pharmaceuticals GmbH, Frankfurt, Germany.

Background: As the number of aesthetic treatments has grown, so have the number of photonumeric assessment scales used to compare the effectiveness of these aesthetic treatments in specific anatomical areas; however, these are primarily based on Caucasian features.

Objective: To assess the validity of the first aesthetic scale for assessing the slope of the Asian forehead. A secondary objective was to correlate this scale with subject demographics and baseline characteristics.

Methods: During 2 validation sessions, 13 raters assessed full frontal and lateral facial images of female (n = 28; 56.0%) and male (n = 22; 44%) subjects. For each subject, the severity of forehead sloping was graded from 0 (convex forehead, optimal forehead volume) to 4 (concave forehead, very severe sloping). Raters also assessed the age of each subject and the estimated aesthetic treatment effort required to treat each subject.

Results: Inter-rater reliability was "substantial" with scores of 0.67 and 0.68 for the first and second validation sessions, indicating high reliability. BMI showed the highest correlation with the scale and was a significant predictor in the final regression model.

Conclusion: This photonumeric assessment scale will be useful for assessing the slope of the Asian forehead in both clinical and research settings.
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http://dx.doi.org/10.1097/DSS.0000000000001997DOI Listing
August 2019

A Validated Assessment Scale for Asian Chin Projection.

Dermatol Surg 2019 08;45 Suppl 1:S30-S37

Aesthetic Breast Surgery Centre, Corduff, Australia.

Background: As the number of different aesthetic treatments increase, numerous photonumeric assessment scales have been developed and validated to measure the effectiveness of these new treatments and techniques. Photonumeric rating scales have been developed to objectively assess improvements in anatomical areas; however, these have been based on the features of Caucasian patients.

Objective: To develop and validate a Chin Projection Scale for use in the female Asian patient population.

Methods And Materials: During 2 validation sessions, 13 raters assessed full frontal and lateral facial views of 50 Asian subjects and also estimated their age and the aesthetic treatment effort required for each subject. Chin projection was rated on a scale from 0 (optimal) to 4 (very severely receding).

Results: Inter-rater reliability was 0.80 (substantial) for Validation Session 1 and 0.83 (almost perfect) for Validation Session 2. The results for Estimated Age and Estimated Treatment Effort were essentially the same.

Conclusion: This study demonstrated the validity of the first photonumeric assessment scale for assessing the appearance of the female Asian chin. This new scale will provide a standardized measure of chin projection for Asian patients in clinical practice and clinical research settings.
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http://dx.doi.org/10.1097/DSS.0000000000001996DOI Listing
August 2019

Validated Assessment Scales for the Female Asian Calf.

Dermatol Surg 2019 08;45 Suppl 1:S22-S29

Merz Pharmaceuticals GmbH, Frankfurt, Germany.

Background: Clinical photonumeric scales have been developed and validated to objectively measure the effectiveness of aesthetic treatments in specific anatomical areas; however, these are based on the typical features of Caucasian patients. No clinical scale for Asian calf appearance currently exists.

Objective: To develop and validate a calf assessment scale for use in the female Asian patient population.

Methods And Materials: During 2 validation sessions, 13 raters assessed calf images of female Asian subjects (N = 35) viewed from behind with feet flat on the floor (at rest) and on tiptoes (dynamic). Images were rated from 0 (very slim, linear profile) to 4 (very severe convex profile).

Results: Inter-rater and intra-rater reliability were "substantial" (≥0.6, intraclass correlation coefficient [ICC] and weighted kappa) for the calf-at rest, calf-dynamic, and calf summary score. Reliability was "substantial" for calf-at rest and calf-dynamic (≥0.6, ICC and weighted kappa) and "almost perfect" (0.85) for the calf summary score. BMI and calf circumference were highly correlated with scale ratings, and calf circumference was a significant predictor.

Conclusion: This new photonumeric assessment scale has value for assessing the female Asian calf, providing a standardized measure of calf appearance in clinical practice and clinical research settings.
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http://dx.doi.org/10.1097/DSS.0000000000002004DOI Listing
August 2019

Arterial Wall Penetration Forces in Needles versus Cannulas.

Plast Reconstr Surg 2019 03;143(3):504e-512e

From private practice and the Department for Hand, Plastic and Aesthetic Surgery, Ludwig Maximilian University; the Department of Medical Education, Albany Medical College; private practice; and Medical School General Hospital, University of Sao Paulo.

Background: If safety is defined as the diminished ability to penetrate facial arteries, the goal of this study was to investigate whether different-sized cannulas are safer than correspondingly sized needles for the application of facial soft-tissue fillers.

Methods: Two hundred ninety-four penetration procedures of the facial and superficial temporal arteries were performed in four fresh frozen cephalic specimens using both needles (20-, 22-, 25-, and 27-gauge) and cannulas (22-, 25-, and 27-gauge). Continuously increasing force was applied and measured until intraarterial penetration occurred.

Results: No statistically significant differences were detected when comparing forces required to penetrate the facial arterial vasculature between different sexes, arteries, or sides of the face (all p > 0.05). Forces needed to penetrate significantly (p < 0.001) decreased with smaller diameter needles (20-gauge, 1.12 ± 0.29 N; 22-gauge, 1.08 ± 0.25 N; 25-gauge, 0.69 ± 0.24 N; and 27-gauge, 0.70 ± 0.29 N) and in cannulas (22-gauge, 1.50 ± 0.31 N; 25-gauge, 1.04 ± 0.36 N; and 27-gauge, 0.78 ± 0.35 N). Comparing 27-gauge injectors, no statistically significant difference was detected between needles and cannulas; an artery could be penetrated with a similar force independent of whether the injector was a needle or a cannula (0.70 ± 0.29 N versus 0.78 ± 0.35 N; p = 0.558).

Conclusions: Cannulas, in all measured sizes except 27-gauge, required greater forces for intraarterial penetration compared with correspondingly sized needles, confirming the safety of 22- and 25-gauge cannulas; 27-gauge cannulas, however, required similar forces as 27-gauge needles, indicating that 27-gauge cannulas are not safer than 27-gauge needles.

Clinical Question/level Of Evidence: Therapeutic, V.
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http://dx.doi.org/10.1097/PRS.0000000000005321DOI Listing
March 2019

Age and Gender Differences of the Frontal Bone: A Computed Tomographic (CT)-Based Study.

Aesthet Surg J 2019 06;39(7):699-710

Department of Medical Education, Albany Medical College, Albany, NY.

Background: Age-related changes of the frontal bone in both males and females have received limited attention, although understanding these changes is crucial to developing the best surgical and nonsurgical treatment plans for this area.

Objectives: To investigate age-related and gender-related changes of the forehead.

Methods: Cranial computed tomographic images from 157 Caucasian individuals were investigated (10 males and 10 females from each of the following decades: 20-29 years, 30-39 years, 40-49 years, 50-59 years, 60-69 years, 70-79 years, 80-89 years, and of 8 males and 9 females aged 90-98 years). Frontal bone thickness and forehead distance measurements were carried out to analyze age and gender differences.

Results: With increasing age, the size of a male forehead reduces until no significant differences to a female forehead is present at old age (P = 0.307). The thickness of the frontal bone of the lower forehead (≤4 cm cranial to the nasal root) increased slightly in both genders with increasing age. In the upper forehead (≥4 cm cranial to the nasal root), frontal bone thickness decreased significantly (P = 0.002) in males but showed no statistically significant change in thickness in females (P = 0.165).

Conclusions: The shape of the frontal bone varies in young individuals of different genders and undergoes complex changes with age because of bone remodeling. Understanding these bony changes, in addition to those in the soft tissues, helps physicians choose the best surgical and nonsurgical treatment options for the forehead.

Level Of Evidence: 4:
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http://dx.doi.org/10.1093/asj/sjy270DOI Listing
June 2019

The Anatomy behind Adverse Events in Hand Volumizing Procedures: Retrospective Evaluations of 11 Years of Experience.

Plast Reconstr Surg 2018 05;141(5):650e-662e

Munich, Germany; Zurich, Switzerland; Tuebingen, Germany; São Paulo and Rio de Janeiro, Brazil; and Albany, N.Y.

Background: To retrospectively evaluate the rate of adverse events after hand volumizing procedures using a calcium hydroxylapatite product and to investigate the relationship between injector used (i.e., needle versus cannula) and technique applied (i.e., bolus, tenting, proximal-to-distal fanning, distal-to-proximal single line).

Methods: Two hundred twenty individuals, including 214 women (97.3 percent) aged 52.3 ± 11.4 years, treated bilaterally for hand rejuvenation were investigated between the years 2006 and 2017. Cadaveric dissections (n = 12), fluoroscopic (n = 4), ultrasound (n = 22), and computed tomographic (n = 4) imaging were also performed to guide conclusions.

Results: Thirty-two of 440 hands (7.3 percent) developed adverse events within the first 15 days, with swelling in 11 (5 percent), pain in four (1.8 percent), erythema in three (1.4 percent), and discoloration in one (0.5 percent). Using a needle (versus a cannula) was significantly related to the occurrence of adverse events (OR, 7.57; 95 percent CI, 3.76 to 15.24; p < 0.001). The proximal-to-distal fanning technique with access to the dorsal superficial lamina was identified as a safer application technique, with each of the other techniques having a significantly increased odds ratio for adverse events: bolus technique (OR, 26.9; 95 percent CI, 6.87 to 105.2; p < 0.001), tenting technique (OR, 24.73; 95 percent CI, 7.48 to 81.76; p < 0.001), and single-line technique (OR, 26.68; 95 percent CI, 7.45 to 95.48; p < 0.001).

Conclusions: The results of this study support the use of cannula versus needle and the proximal-to-distal fanning technique. The underlying anatomy supports the positioning of the material into the subdermal space, which can be identified less than 1 mm deep to the skin surface, and is termed the dorsal superficial lamina.
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http://dx.doi.org/10.1097/PRS.0000000000004211DOI Listing
May 2018

Combined aesthetic interventions for prevention of facial ageing, and restoration and beautification of face and body.

Clin Cosmet Investig Dermatol 2017 30;10:423-429. Epub 2017 Oct 30.

Doctors Inc., Amsterdam, The Netherlands.

The Merz Institute of Advanced Aesthetics Expert Summit was held in Prague, Czech Republic, from 19-20 November 2016. The meeting had a distinct advisory board character and invited aesthetic practitioners from all over the world to hear an international faculty present a range of keynote lectures and conduct live injection sessions with an emphasis on recent developments in combination aesthetic interventions for face and body rejuvenation and beautification. Aging is associated with changes in bones, muscles, ligaments, adipose tissue, and skin and, moreover, involves interactions among these tissue types. To achieve the most natural and harmonious rejuvenation of the face, all changes that result from the aging process should be corrected, which generally involves treatment with more than a single agent or technology. Presentations described innovative treatment algorithms for the face and body and focused on patients' desires for natural-looking rejuvenation and how this requires a three-dimensional approach combining products that relax the musculature, volumize, and re-drape the skin. Besides treating the aging face, these procedures are increasingly used to enhance facial features as well as to delay facial aging in younger patients. The presentations covered patients from different ethnicities as well as the treatment of non-facial areas, with a particular focus on the use of Ultherapy for skin lifting and tightening, and new aesthetic procedures such as Cellfina and diluted Radiesse. The current report provides a summary of key presentations from the meeting.
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http://dx.doi.org/10.2147/CCID.S144282DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5669783PMC
October 2017

PAN-ASIAN CONSENSUS-Key Recommendations for Adapting the World Congress of Dermatology Consensus on Combination Treatment with Injectable Fillers, Toxins, and Ultrasound Devices in Asian Patients.

J Clin Aesthet Dermatol 2017 Aug 1;10(8):16-27. Epub 2017 Aug 1.

Dr. Chao is with Chao and Chiu Institute of Dermatology, Taipei,Taiwan; Dr. Chhabra is with Skin Alive Clinic, New Delhi, India.

The demand for minimally invasive aesthetic procedures has driven requests by physicians for guidance on their use in Asian patients, who have unique cultural preferences, social trends, and anatomy. However, few guidelines exist, particularly on combination treatment strategies for different facial shapes or indications such as the modification of face shapes to the "oval ideal."Physicians must, therefore, apply Caucasian patient-optimized guidelines to their Asian patients. Eleven specialists developed a consensus on the use of botulinum toxin A (BoNT-A), calcium hydroxylapatite (CaHA) and hyaluronic acid (HA) fillers, and microfocused ultrasound with visualization (MFU-V) devices in Asian patients on upper-, middle-, and lower-face indications, including strategies to modify different facial shapes to the oval shape. Approval from 70 to 90 percent of all participants led to moderate consensus, while 90 percent agreement denoted a strong consensus. For early intervention/enhancement and restoration, most combination strategies are similar between Asian and Caucasian patients. Compared to Caucasian patients, however, beautification is a more common focus in Asian patients. The "ideal" oval facial shape can be created using different interventions depending on the patient's baseline characteristics. Although treatments and treatment sequences for early intervention/enhancement and restoration for beautification in Asian patients are similar to those in Caucasian patients, different treatment strategies may be required.
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http://www.ncbi.nlm.nih.gov/pmc/articles/PMC5605210PMC
August 2017

Precision in Dermal Filling: A Comparison Between Needle and Cannula When Using Soft Tissue Fillers.

J Drugs Dermatol 2017 Sep;16(9):866-872

Background: Precise implantation of soft tissue fillers to treat the signs of aging is crucial for patient safety and the best aesthetic outcome. Injections are performed commonly with either needles or cannulas, but quantitative comparative data on precise implantation are still elusive.

Methods: Ten fresh-frozen cephalic foreheads (9 male, 1 female) were injected with radiopaque material using both needles and cannulas. Needle injection relied on a perpendicular transcutaneous approach, whereas cannulas were moved in the supra-periosteal plane until reaching the same location as the needle. Two-dimensional distribution of the material in the horizontal and in the vertical axes was quantified using fluoroscopic imaging. Additional CT and MR imaging was performed to confirm results.

Results: The two-dimensional extent of injected material in the horizontal plane was 25.6 mm±10.5 mm vs 13.5 mm ± 6.5 mm (cannula vs needle; P=0.006) and 3.0 mm ± 0.90 mm vs 3.99 mm ± 0.97 mm (cannula vs needle; P=0.028) in the vertical plane. In 60% of injections using a needle, the implanted material changed its plane; this was not observed when using the cannula (0%; P=0.003). Retrograde backflow, however, was greater with a cannula (90.2%) compared to a needle (33.3%).

Conclusions: If precision in filler injection is defined as the filler material remaining in the plane of intended implantation, then using cannulas resulted in a more precise injection of material as compared to needles. Applications with needles resulted in the distribution of material into more superficial layers, which was not noted for cannulas.

J Drugs Dermatol. 2017;16(9):866-872.

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September 2017

Communication Concepts for Prevention and Early Intervention in Aesthetic Medicine: Consensus and Literature Review.

J Drugs Dermatol 2017 Sep;16(9):859-864

Background: Communication concepts relating to prevention and early intervention (P&E) within aesthetic medicine are poorly understood and highly underexplored. However, effective communication is a key criterion for successful outcomes.

Objectives: To introduce the framework for P&E communication strategies within a younger population and explore the barriers that may be encountered.

Methods: A literature review on P&E communication strategies in aesthetic medicine and related topics of interest was conducted and used to construct a working framework that may be applied in clinical practice.

Results: Examination of existing literature revealed a need for a more structured communication framework for P&E encompassing up-to-date evidence-based learning and educational marketing that is tailored to individual needs and target populations. Message framing-the way in which a message is presented-is an important consideration in the dissemination of information to promote changes in health behaviour. A structured consultation is key to optimising patient engagement and ensures a tailored approach to understanding and catering to the specific needs of each patient.

Conclusion: This is the first paper to discuss the communication concepts behind P&E within aesthetic medicine and paves the way for further research and focus in this significant field.

J Drugs Dermatol. 2017;16(9):859-864.

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September 2017

First Consensus on Primary Prevention and Early Intervention in Aesthetic Medicine.

J Drugs Dermatol 2017 Sep;16(9):846-854

Background: Facial aging is a complex interplay of extrinsic and intrinsic factors leading to progressive changes in the skin, subcutaneous tissue, and bone. Clinical experience suggests that early aesthetic intervention may slow the signs of aging, but treatment in the absence of symptoms or with minimal signs of aging has not yet been properly addressed.

Objectives: To provide treatment recommendations for primary prevention and early intervention in individuals with no or minimal signs of aging.

Methods: Fourteen specialists in aesthetic medicine convened over a full-day meeting under the guidance of a certified moderator.

Results: Tailored treatment recommendations have been provided for prevention and early intervention of fine wrinkles, static lines and folds, irregular pigmentation, laxity, and subcutaneous volume loss by protecting the epidermis, stimulating neocollagenesis, reducing hyperkinetic musculature, and reinforcing supporting structures.

Conclusion: Preventive measures and early therapeutic interventions that may alter the course of facial aging were defined. Further studies are needed to support these recommendations with the best possible evidence.

J Drugs Dermatol. 2017;16(9):846-854.

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September 2017

An Update on the Anatomy of the Forehead Compartments.

Plast Reconstr Surg 2017 Apr;139(4):864e-872e

Roseau, Commonwealth of Dominica, West Indies; Salzburg, Austria; Sacramento, Calif.; Munich, Germany; Casablanca, Morocco; and Catania, Italy.

Background: The forehead is one of the most frequent locations for neuromodulator and soft tissue filler applications; however, the underlying anatomy is still poorly understood. Thus far, the presence of deep forehead compartments has not been confirmed.

Methods: Twenty Caucasian cephalic specimens, 15 fresh frozen (six female and nine male) and five with formalin-phenol embalmment (three female and two male) were investigated using contrast-enhanced computed tomographic scans, dye injections, and anatomical dissections.

Results: Three superficial (one central and two lateral) and three deep (one central and two lateral) forehead compartments were identified. The superficial fat compartments were found within the subcutaneous fat tissue (layer 2) and measured 2.1 × 4.6 mm for the superficial central forehead compartments and the right superficial lateral forehead compartments and 2.6 × 3.2 cm for the left superficial lateral forehead compartments, with a mean volume of 2.5, 3.1, and 3.4 cc, respectively. The deep fat compartments were identified deep to the frontalis muscle but superficial to the periosteum with an extent of 6.4 × 5.9 cm for the deep central forehead compartments, 2.6 × 5.8 cm for the right deep lateral forehead compartments, and 2.7 × 5.8 cm for the left deep lateral forehead compartments, and a mean volume of 9.1, 1.6, and 1.4 cc, respectively.

Conclusions: The results presented in this study increase the understanding of the forehead anatomy. Understanding the presence of the superficial and the deep forehead compartments allows one to change the signs of frontal aging. The deep forehead compartments are in general avascular planes and permit blunt dissection for access to the supraorbital region.
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http://dx.doi.org/10.1097/PRS.0000000000003174DOI Listing
April 2017

Liquid Formulation of AbobotulinumtoxinA Exhibits a Favorable Efficacy and Safety Profile in Moderate to Severe Glabellar Lines: A Randomized, Double-Blind, Placebo- and Active Comparator-Controlled Trial.

Aesthet Surg J 2018 Feb;38(2):183-191

Dermatologist and Clinical Epidemiologist (ScM) at RZANY & HUND, a private practice in Berlin, Germany.

Background: In most countries, approved botulinum toxin type A formulations require reconstitution before injection.

Objectives: To evaluate the efficacy and safety of a ready-to-use liquid formulation of abobotulinumtoxinA (abobotulinumtoxinA solution for injection, ASI) in subjects with moderate to severe glabellar lines (GL).

Methods: In this Phase II, double-blind, placebo-controlled, randomized study, 176 female subjects (aged 30 to 60 years) were randomized into five treatment groups: ASI 20, 50, or 75 U, reconstituted abobotulinumtoxinA (aboBoNT-A) 50 U, and placebo. GL severity was assessed at maximum frown using a 4-point grading scale. Responders were subjects with severity grade of moderate [2] or severe [3] at baseline improving to none [0] or mild [1], evaluated at each time-point by Investigator's Live Assessment (ILA) or Subject's Self-Assessment (SSA). Safety profiles were also determined.

Results: Baseline characteristics were similar across groups. Responder rates on Day 29 by ILA were significantly greater for ASI 20, 50, and 75 U versus placebo (88.9%, 91.4%, and 87.9% vs. 0%, respectively; P < 0.0001). Similar results were observed by SSA. A greater proportion of responders was observed in ASI groups vs placebo from Day 8 to 113 for ILA and SSA (P < 0.001). AboBoNT-A responder rate on Day 29 for ILA was 77.1% (P < 0.1006 vs ASI 50 U); with comparable results by SSA. The ASI safety profile was comparable to that of aboBoNT-A.

Conclusions: Ready-to-use liquid formulation of abobotulinumtoxinA was shown to be efficacious, with comparable results to reconstituted abobotulinumtoxinA, and to have a favorable safety profile in subjects with severe to moderate GL.
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http://dx.doi.org/10.1093/asj/sjw272DOI Listing
February 2018

Consensus Recommendations for Combined Aesthetic Interventions Using Botulinum Toxin, Fillers, and Microfocused Ultrasound in the Neck, Décolletage, Hands, and Other Areas of the Body.

Dermatol Surg 2016 Oct;42(10):1199-1208

*Cosmetic Laser Dermatology, San Diego, California;†Center for Dermatology and Dermatologic Surgery, Washington, DC;‡University of British Columbia, Vancouver, Canada;§Day Dermatology and Aesthetics, New York, New York;‖European Medical Aesthetics Ltd., London, United Kingdom;¶University of Hamburg, Hamburg, Germany;#Victoria Park Medispa, Montreal, Canada;**Private Practice for Dermatology and Aesthetics, Munich, Germany;††Leaders Clinic, Seoul, Korea;‡‡RZANY & HUND, Berlin, Germany;§§Rosenparkklinik, Darmstadt, Germany;‖‖Seoul National University, Seoul, Korea;¶¶University of Washington, Seattle, Washington;##Rosenparkklinik, Darmstadt, Germany.

Background: The popularity of aesthetic procedures in the face has led to greater disparity between treated areas and those that still show evidence of true age. Although many areas of the body often require multiple treatment procedures for optimal rejuvenation, combination therapy for specific areas is not yet well defined.

Objective: To develop recommendations for the optimal combination and ideal sequence of botulinum toxin (BoNT), hyaluronic acid, calcium hydroxylapatite (CaHA), and microfocused ultrasound with visualization in nonfacial areas across all skin phototypes.

Methods: Fifteen specialists convened under the guidance of a certified moderator. Consensus was defined as approval from 75% to 94% of all participants, whereas agreement of ≥95% denoted a strong consensus.

Results: Recommendations have been provided for the neck, décolletage, and hands and include the timing and sequence of specific procedures when used concurrently or over several treatment sessions. Position statements are offered in lieu of consensus for the upper arms, abdomen, buttocks, and knees.

Conclusion: Nonfacial rejuvenation often requires multiple procedures for optimal results in individuals with significant age-related changes. Further clinical studies are recommended to raise awareness of non-facial indications and provide clinicians with the best evidence for best treatment practices.
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http://dx.doi.org/10.1097/DSS.0000000000000869DOI Listing
October 2016

The Anatomy of the Aging Face: A Review.

Facial Plast Surg 2016 Jun 1;32(3):253-60. Epub 2016 Jun 1.

Private Practice in Dermatology and Aesthetics, Munich, Germany.

Rejuvenative procedures of the face are increasing in numbers, and a plethora of different therapeutic options are available today. Every procedure should aim for the patient's safety first and then for natural and long-lasting results. The face is one of the most complex regions in the human body and research continuously reveals new insights into the complex interplay of the different participating structures. Bone, ligaments, muscles, fat, and skin are the key players in the layered arrangement of the face.Aging occurs in all involved facial structures but the onset and the speed of age-related changes differ between each specific structure, between each individual, and between different ethnic groups. Therefore, knowledge of age-related anatomy is crucial for a physician's work when trying to restore a youthful face.This review focuses on the current understanding of the anatomy of the human face and tries to elucidate the morphological changes during aging of bone, ligaments, muscles, and fat, and their role in rejuvenative procedures.
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http://dx.doi.org/10.1055/s-0036-1582234DOI Listing
June 2016

Tempering Patient Expectations and Working With Budgetary Constraints When It Comes to a Single Versus a Multimodal Approach.

Dermatol Surg 2016 May;42 Suppl 2:S161-4

*Skin Care and Laser Physicians of Beverly Hills, Los Angeles, California; †Dermatology and Aesthetics of Munich, Munich, Germany; ‡Dermatology Department, Medicine at University of California Los Angeles, Los Angeles, California.

Background: This article is a review of the literature and the authors' experience in managing patients seeking facial and nonfacial rejuvenation procedures with budgetary constraints.

Objective: To provide readers with an approach to the cosmetic patient with financial limitations.

Methods And Materials: This article is written from a review of the literature and the authors' experience.

Results: The readers should learn how to better manage a patient with financial limitations seeking cosmetic procedures.

Conclusion: Because patients seeking cosmetic procedures are often faced with budgetary constraints, it is important for the cosmetic physician to educate patients about available treatment options and their costs. Giving patients realistic expectations and tailoring treatment plans to the patient's primary goals and financial limitations can help maximize overall patient satisfaction.
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http://dx.doi.org/10.1097/DSS.0000000000000688DOI Listing
May 2016

Consensus Recommendations for Combined Aesthetic Interventions in the Face Using Botulinum Toxin, Fillers, and Energy-Based Devices.

Dermatol Surg 2016 May;42(5):586-97

*University of British Columbia, Vancouver, Canada; †Center for Dermatology and Dermatologic Surgery, Washington, D.C.; ‡Day Dermatology and Aesthetics, New York City, New York; §Cosmetic Laser Dermatology, San Diego, California; ‖European Medical Aesthetics Ltd., London, United Kingdom; ¶University of Hamburg, Hamburg, Germany; #Victoria Park Medispa, Montreal, Canada; **Private Practice for Dermatology and Aesthetics, Munich, Germany; ††Leaders Clinic, Seoul, Korea; ‡‡RZANY & HUND, Berlin, Germany; §§Rosenparkklinik, Darmstadt, Germany; ‖‖Seoul National University, Seoul, Korea; ¶¶University of Washington, Seattle, Washington.

Background: The aging process is a complex interplay of intrinsic and extrinsic factors across multiple layers of the face. Accordingly, combining aesthetic interventions targeting different manifestations of aging often leads to better results than single modalities alone. However, no guidelines for a pan-facial approach using multiple interventions have been published to date.

Objective: To develop consensus recommendations for the optimal combination and ideal sequence of botulinum toxin (BoNT), hyaluronic acid, calcium hydroxylapatite, and microfocused ultrasound with visualization (MFU-V) in persons of all Fitzpatrick skin types.

Methods And Materials: Fifteen specialists convened under the guidance of a certified moderator. Consensus was defined as approval from 75% to 94% of all participants, whereas agreement of ≥95% denoted a strong consensus.

Results: Optimal aesthetic treatment of the face begins with a thorough patient assessment and an individualized treatment plan. Spacing consecutive treatments 1 to 2 weeks apart allows for resolution of side effects and/or to assess results. For same-day treatments, BoNT and fillers may be performed together in either sequence, whereas MFU-V is recommended before injectable agents.

Conclusion: Expert consensus supports a combination approach using multiple modalities in specific sequence for the safe and effective treatment of the aging face.
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http://dx.doi.org/10.1097/DSS.0000000000000754DOI Listing
May 2016

IncobotulinumtoxinA use in aesthetic indications in daily practice: a European multicenter, noninterventional, retrospective study.

Clin Cosmet Investig Dermatol 2015 5;8:135-42. Epub 2015 Mar 5.

Department of Ophthalmology, Adolphe Rothschild Ophthalmological Foundation, Paris, France.

Purpose: To characterize utilization patterns and treatment satisfaction with incobotulinumtoxinA for aesthetic indications and assess adherence to the Summary of Product Characteristics.

Patients And Methods: Data were collected retrospectively from physicians in Germany, France, and the UK regarding patients (n=638) treated with incobotulinumtoxinA for aesthetic indications. Data on indication, treatment interval, dose injected, physician and patient satisfaction, and adverse drug reactions were recorded according to routine daily practice.

Results: Most patients (76.0%) received incobotulinumtoxinA for glabellar frown lines (GFL) and were given doses of ≤20 U. The majority of treatment intervals were 5 months or longer. Overall, 64.1% of patients were treated for off-label indications, sometimes in combination with treatment for GFL. The most frequently treated off-label indications were horizontal forehead lines (38.6%) and/or crow's feet (CF; 31.7%); for CF, >95% of injected doses were ≤24 U. In Germany, a smaller proportion of patients were given incobotulinumtoxinA treatment for CF (27.6%), compared with France (40.4%) and the UK (33.2%), although country-specific differences were less prominent when treatment cycle data for CF were examined. Treatment satisfaction among physicians and patients (overall, and for GFL specifically) was very high, with excellent tolerability and only one mild adverse drug reaction reported.

Conclusion: In daily practice, incobotulinumtoxinA is mainly used for GFL; however, its use for CF and horizontal forehead lines (often in combination with GFL) is relatively common. Treatment satisfaction across aesthetic indications is high, and incobotulinumtoxinA is well tolerated, with time intervals of 5 months or longer between injections in the majority of cases. When considering factors such as dose and treatment interval, adherence to the Summary of Product Characteristics when treating GFL in daily practice is good. These results support previous reports that incobotulinumtoxinA is an effective treatment for GFL, with an excellent safety profile. Furthermore, incobotulinumtoxinA may display efficacy and tolerability in other indications.
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http://dx.doi.org/10.2147/CCID.S74519DOI Listing
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4358057PMC
April 2015