Publications

New procedures in facial plastic surgery using botulinum toxin A

Publication Number: 15062256

New indications for botulinum toxin A injection in facial plastic surgery have begun to emerge beyond the management of facial rhytids. This paper described a role for botulinum toxin in the rehabilitation from facial nerve paralysis, in the pharmacologic browlift, and in the nonsurgical management of platysmal bands. These procedures are not meant as a replacement for surgery, but rather as a less invasive alternative, or as an adjunctive modality. They are most useful in cases of functional or dynamic disorders, as opposed to problems of excessive or lax tissues. This article presented several clinical studies that give supportive evidence for the efficacy of the procedures. Further, larger studies with more objective measurements are necessary before these procedures become widely accepted.

Publication Date: November 7, 2003

Authors: Howard D Stupak, Corey S Maas

The First of Two One-Year, Multicenter, Open-Label, Repeat-Dose, Phase II Safety Studies of PrabotulinumtoxinA for the Treatment of Moderate to Severe Glabellar Lines in Adult Patients

Publication Number: 33944905

Background: PrabotulinumtoxinA is a 900-kDa botulinum toxin type A produced by Clostridium botulinum.

Objectives: The authors sought to investigate the safety of prabotulinumtoxinA for treatment of glabellar lines.

Methods: This was a multicenter, open-label, repeat-dose, 1-year phase II safety study. Adults with moderate to severe glabellar lines at maximum frown, as assessed by the investigator on the validated 4-point photonumeric Glabellar Line Scale (0 = no lines, 1 = mild, 2 = moderate, 3 = severe), were enrolled. On day 0, patients received an initial treatment of 20 U prabotulinumtoxinA (4 U/0.1 mL freeze-dried formulation injected into 5 target glabellar sites). On and after day 90, patients received a repeat treatment (RT) if their Glabellar Line Scale score was ≥2 at maximum frown by investigator assessment. Safety was evaluated throughout the study.

Results: The 352 study patients received a median total dose of 60 U, that is, 3 treatments per year. Fifty-one patients (14.5%) experienced adverse events (AEs) assessed as possibly study drug related; 11.1% experienced study drug-related AEs after the initial treatment. With each RT, progressively lower percentages of patients experienced study drug-related AEs. Six patients (1.7%) experienced study drug-related AEs of special interest: 3 eyelid ptosis (0.9%), 2 speech disorder (0.6%), and 1 blepharospasm (0.3%). Seven patients (2.0%) experienced serious AEs; none were study drug related. Of the 2393 samples tested, 2 patients (0.6%) tested positive for antibotulinum toxin antibodies at a single postbaseline visit.

Conclusions: The safety of RTs of 20 U of prabotulinumtoxinA for moderate to severe glabellar lines was first established in this early phase II study based on a broad range of outcomes.

© 2021 The Aesthetic Society.

Publication Date: November 12, 2021

Authors: Joely Kaufman-Janette, Rui L Avelar, Brian S Biesman, Zoe Diana Draelos, John E Gross, Derek H Jones, Mary P Lupo, Corey S Maas, Joel Schlessinger, Ava Teresa Shamban, Hema Sundaram, Susan H Weinkle, Vernon L Young

A validated rating scale for hyperkinetic facial lines

Publication Number: 15262720

Objective: To test the reliability of a simple rating system to describe hyperkinetic facial lines.

Methods: A rated numeric kinetic line scale was developed and presented to 11 postresidency physicians specializing in aesthetic facial care. These physicians independently reviewed photographs of 20 patients, first at rest, then with activation of the frontalis, corrugator, and orbicularis oculi muscles. Kappa statistics for multiple raters were used to assess interobserver reliability.

Results: The nonweighted kappa values were between 0.4 and 0.8 for the frontalis, corrugator, and orbicularis muscle groups. This represents moderate to substantial observer agreement and is highly significant for each muscle group.

Conclusions: A new rating scale for hyperkinetic facial lines accounts for facial appearance at rest and with expression. It is easily used and has interobserver reliability. As the only objective and validated scale for hyperkinetic facial lines, this rated numeric kinetic line scale is recommended for the evaluation of pretreatment and posttreatment results in patients undergoing therapy for this problem. Moreover, an alternative scale rating resting and kinetic lines as independent variables is also being developed. Both must be considered to evaluate treatment outcomes when using neurotoxins.

Publication Date: August 1, 2004

Authors: Eugene J Kim, Jay B Reeck, Corey S Maas

A Randomized, Blinded, Prospective Clinical Study Comparing Small-Particle Versus Cohesive Polydensified Matrix Hyaluronic Acid Fillers for the Treatment of Perioral Rhytids

Publication Number: 32506124

Background: Perioral rhytids are a bothersome sign of aging for many patients. Although multiple treatments exist, choosing an optimal modality may be difficult considering that rhytids in this region are fine and the anatomy dynamic.

Objectives: The authors sought to compare the efficacy and safety as well as patient satisfaction of a small-particle hyaluronic acid filler with 0.3% lidocaine (SP-HAL, Restylane Silk) and cohesive polydensified matrix hyaluronic acid filler (CPM-HA, Belotero Balance) in reducing superficial perioral rhytids.

Methods: The study was double-blinded, and 48 patients with moderate to severe superficial perioral rhytids were enrolled. Patients were randomized to receive either CPM-HA in the left perioral region and SPHAL in the right or vice versa. Rhytid severity was measured by patients utilizing a linear analog scale, and by investigators utilizing a validated 5-point scale, for 180 days following treatment.

Results: Both SP-HAL and CPM-HA achieved a reduction in rhytid severity, and neither treatment group returned to baseline after 180 days. Investigator-reported scores for rhytid severity were significantly better for SP-HAL than CPM-HA and remained so at 180 days (P < .05). SP-HAL also proved significantly better for reducing rhytids according to patient scores, although this difference occurred between 120 and 180 days only. Adverse events included rash and mild acne for CPM-HA, and SP-HAL was associated with 1 postinflammatory nodule and 2 occurrences of Tyndall effect. Conclusions: Although both SP-HAL and CPM-HA are effective at reducing perioral rhytid severity and have similar safety profiles, SP-HAL possesses a longer duration of effect. © 2020 The Aesthetic Society. Reprints and permission: journals.permissions@oup.com.

Publication Date: May 18, 2021

Authors: Marc A Polacco, Adam E Singleton, Teresa Luu, Corey S Maas

Twelve-month persistency of a novel ribose-cross-linked collagen dermal filler

Publication Number: 18547179

Background: The porcine collagen-derived dermal filler Dermicol-P35 (Evolence, Colbar LifeScience Ltd, Herzliya, Israel) has low immunogenicity and the potential to provide a long-lasting corrective response for soft-tissue contour deficiencies and deformities. OBJECTIVE The objective was to assess the persistence of the corrective response with Dermicol-P35 up to 12 months after obtaining an optimal cosmetic result (OCR) in a randomized, multicenter study comparing the efficacy and safety of Dermicol-P35 with the hyaluronic acid (HA) filler Restylane (Medicis Pharmaceutical Co.).

Methods & materials: Subjects with moderate to deep nasolabial wrinkles (n=149) were randomized to injections of either Dermicol-P35 or HA on one side of the face and the alternative preparation on the contralateral side. If necessary, one touch-up injection could be given after 2 weeks to obtain an OCR.

Results: Although the mean Modified Fitzpatrick Wrinkle Scale score increased gradually after achieving the OCR with Dermicol-P35, 95.3 and 76.5% of subjects, respectively, met the criteria for persistence of the corrective response after 9 and 12 months. Persistency rates were similar regardless of the requirement for a touch-up injection at Week 2. No unexpected, severe, or serious injection-related adverse events were experienced.

Conclusion: The effectiveness of Dermicol-P35 appears to be maintained for up to 1 year after achieving an OCR, both for touch-up and for non-touch-up subjects.

Publication Date: June 7, 2008

Authors: Rhoda S Narins, Fredric S Brandt, Z Paul Lorenc, Corey S Maas, Gary D Monheit, Stacy R Smith

A Double-Blind, Randomized Clinical Trial to Determine Effects of Increasing Doses and Dose-Response Relationship of IncobotulinumtoxinA in the Treatment of Glabellar Rhytids

Publication Number: 32722793

Background: IncobotulinumtoxinA is an effective neuromodulator for treating glabellar rhytids. The relationship between dose and reduction in rhytid severity is well established. However, the effects of escalating doses on the treatment duration response are less understood.

Objectives: The aim of this study was to assess the effects of increasing doses of incobotulinumtoxinA on the treatment duration for glabellar rhytids.

Methods: A randomized, double-blind, Phase IV study was conducted at a fully accredited, outpatient surgical facility. Subjects (31 female, 7 male) with moderate to severe glabellar rhytids were randomized to 1 of 3 incobotulinumtoxinA dose groups: 20, 60, or 100 U. Effect duration was determined by calculating the time to return to baseline for dynamic glabellar lines during maximal contraction. Follow-up was completed through 1 year, and adverse events were monitored.

Results: The median duration of effect was 120 days (95% confidence interval [CI] [90, 180 days]), 180 days (95% CI [180, 210 days]), and 270 days (95% CI [240, 330 days]) for the 20-, 60-, and 100-U groups, respectively. A Wald chi-square test from the Cox regression on the primary efficacy variable indicated a statistically significant effect of dose group on time to baseline (chi square = 54.63; df = 2; P < 0.001). Hazard ratios were HR = 0.21 (95% CI [0.10; 0.43] for the 60-U vs the 20-U group, and HR = 0.06 (95% CI [0.10; 0.43]) for the 100-U vs the 20-U group, indicating a statistically longer return to baseline for both the 60- and 100-U cohorts. Conclusions: There is a dose-dependent relationship between incobotulinumtoxinA and duration of effect in the glabella. © 2020 The Aesthetic Society. Reprints and permission: journals.permissions@oup.com.

Publication Date: May 18, 2021

Authors: Marc A Polacco, Adam E Singleton, Christian H Barnes, Conner Maas, Corey S Maas

Juvederm ultra for lip enhancement: an open-label, multicenter study

Publication Number: 23515385

Background: Juvéderm Ultra injectable gel (Allergan, Inc, Irvine, California) is approved in the United States to treat moderate to severe wrinkles and folds, such as nasolabial folds. It is also used to enhance the appearance of the lips.

Objectives: The authors evaluated the safety and effectiveness of Juvéderm Ultra injectable gel for lip enhancement and assessed the utility of 3 new lip-specific effectiveness scales.

Methods: In this multicenter study, 50 subjects received lip enhancement with Juvéderm Ultra injectable gel. The subjects were observed closely by the treating investigator and results were evaluated by a blinded independent rater and by subject self-assessment for up to 48 weeks to determine the durability of the effects. A validated lip fullness scale (LFS) was used for analysis. Treatment satisfaction was assessed by investigators and subjects using an 11-point scale.

Results: At week 12, 71% of subjects had achieved their goals for lip fullness and had maintained improvement of at least 1 grade on the LFS, which greatly exceeded the a priori criterion of 40% for success. At week 24, improvement in lip fullness was still present for 56% of subjects. Satisfaction and goal achievement exceeded 90% for subjects as well as investigators. Common side effects were predominantly mild or moderate in intensity and resolved within 1 week in the majority of subjects.

Conclusions: Juvéderm Ultra injectable gel is safe and effective for lip enhancement. Scales for assessing lip fullness provide an objective method to determine the effectiveness of treatment.

Publication Date: March 7, 2013

Authors: Steven Fagien, Corey Maas, Diane K Murphy, Jane A Thomas, Frederick C Beddingfield 3rd; Juvéderm Lips Study Group

Safety and Effectiveness of Microfocused Ultrasound With Visualization for the Correction of Moderate to Severe Atrophic Acne Scars

Publication Number: 31741353

Objective: To assess the effectiveness of microfocused ultrasound with visualization (MFU-V) for treating moderate to severe atrophic acne scars. Design: Healthy subjects (N=20) seeking correction of moderate to severe atrophic acne scars on the cheeks and/or temples were enrolled. Scars were predominantly rolling- and boxcar-type, affecting an area ≥5.0cm2. Eighteen subjects completed the study. Intervention: The treatment area was marked with 14mm2 and 25mm2 squares and treated with four transducers: 7 MHz (3.0mm focal depth) and 10 MHz (1.5mm focal depth), each in 14mm and 25mm widths. During each session, MFU-V treatment lines were applied 2-3mm apart, within each treatment area, with a maximum length of 25mm. Each square received 30 treatment lines at two transducer depths (60 total lines). Subjects received three total treatments, with 30 days between each session. The primary outcome measure was improvement in baseline appearance of scars at 90 and 180 days after the final treatment. Secondary outcome measures included changes in severity using an Acne Scar Improvement Scale (ASIS) and Global Aesthetic Improvement Scale (GAIS) at 60-, 90-, and 180-days post-treatment, and a satisfaction questionnaire at 90-days post-treatment. Results: Among the 90-day images available for assessments (n=11), 100% were rated as improved by blinded reviewers, and 64% of pre- and post-treatment images were correctly selected. Among 180-day images (n=15), 100% were rated as improved, and 40% of pre- and post-treatment images were correctly selected. Most subjects were determined to have 25-50% improvement in investigator ASIS scores at 60-, 90-, and 180-days post-treatment. All subjects noted some improvement in severity at the 60-day assessment when measured using ASIS. Based on investigator GAIS scores, 100% of subjects were “Improved” or “Much Improved” at 60-, 90-, and 180-days post-treatment. Based on subject GAIS scores, all subjects noted improvement at the 60-day assessment, and 83% and 89% at the 90- and 180-day assessments, respectively. Overall, 17 subjects (94.4%) expressed some degree of satisfaction at 90-days post-treatment. Conclusions: The results of this study demonstrated that MFU-V therapy is beneficial and well tolerated for the treatment of rolling- and boxcar-type acne scars. J Drugs Dermatol. 2019;18(11):1109-1114.

Publication Date: November 1, 2019

Authors: Corey S. Maas, John H. Joseph

An internally controlled, double-blind comparison of the efficacy of onabotulinumtoxinA and abobotulinumtoxinA

Publication Number: 21690460

Objective: To compare 2 commercially available botulinum neuromodulators in a randomized, double-blind, split-face study.

Methods: Ninety patients were treated with 10 U of onabotulinumtoxinA and 30 U of abobotulinumtoxinA for the treatment of lateral orbital rhytids. Patients were assessed live with a validated 5-point photographic scale prior to treatment and at 30 days. Patients were also photographed at each visit.

Results: AbobotulinumtoxinA demonstrated a statistically significant advantage compared with onabotulinumtoxinA in the treatment of lateral orbital rhytids at maximal contraction, as evaluated independently by the investigator (P = .01) and patient (P = .03). AbobotulinumtoxinA was also favored by the patient over onabotulinumtoxinA 67% of the time. While abobotulinumtoxinA seemed to treat lateral orbital rhytids better at rest, as evidenced by the data and photographs, this difference was not statistically significant (P = .42).

Conclusions: AbobotulinumtoxinA offers superior efficacy in the treatment of lateral orbital rhytids compared with onabotulinumtoxinA. Further studies are needed to compare the 2 products in different muscle groups and for other indications.

Publication Date: November 11, 2011

Authors: Kartik D Nettar, Kenneth C Y Yu, Sumit Bapna, John Boscardin, Corey S Maas

Pins and needles: minimally invasive office techniques for facial rejuvenation

Publication Number: 19924599

The desire for minimally invasive facial rejuvenation has continued to increase from the perspective of both the patients and injectors. For successful rejuvenation, it is important to understand the anatomic changes of the aging face as well as the properties of available neuromodulators and soft tissue fillers. The injector should be knowledgeable of the advantages and disadvantages of each product. Patient selection, perhaps, plays the largest role in success, choosing patients that would truly benefit from and have reasonable expectations for minimally invasive techniques. Unsatisfactory outcomes can be limited by meticulous injection technique and well thought out treatment plans.

Copyright Thieme Medical Publishers.

Publication Date: November 25, 2009

Authors: Corey S Maas, Sumit Bapna

Relevant anatomy for botulinum toxin facial rejuvenation

Publication Number: 15062247

Over the last several years, Botox has become an integral treatment modality in the management of facial aging. Through selective chemical denervation, rhytids that are associated with hyperfunctioning muscles can be considerably softened or eliminated. Most practitioners rely on surface anatomy and landmarks to guide accurate needle insertion and Botox therapy. Therefore, a detailed appreciation of the underlying muscular anatomy is paramount in improving the practitioner’s cosmetic results and the patients’ overall satisfaction.

Publication Date: November 11, 2003

Authors: Benjamin M Loos, Corey S Maas

Anatomic considerations for treatment with botulinum toxin

Publication Number: 17317550

Botulinum toxin A treatment continues to increase in popularity and number. Many more patients are undergoing cosmetic Botox procedures and many, diverse practitioners are providing them. The best results are obtained from a careful history and physical examination of the patient combined with a detailed understanding of facial and neck anatomy. Understanding the dynamic anatomic relationships, such as agonist-antagonist muscles and contraction force vectors, is key to providing the patient with an excellent outcome.

Publication Date: February 15, 2007

Authors: Gary M Petrus, David Lewis, Corey S Maas