Split-face double-blind study comparing the onset of action of onabotulinumtoxinA and abobotulinumtoxinA

Publication Number: 22183059

Objective: To report and discuss the outcome of a prospective, internally controlled, randomized, double-blind, split-face study comparing the onset of action of 2 commercially available botulinum neuromodulators.

Methods: Ninety individuals with moderate-to-severe lateral orbital rhytids were treated with onabotulinumtoxinA, 10 U, and abobotulinumtoxinA, 30 U, for the treatment of lateral orbital rhytids. Participants were assessed live with a validated 5-point photographic scale before treatment and on days 2, 4, and 6 after treatment. Photographs were taken at each encounter. Statistical analysis was applied to evaluate for any significant difference in onset of action between the 2 products.

Results: AbobotulinumtoxinA and onabotulinumtoxinA demonstrated statistically significant change from baseline at day 2 in the treatment of lateral orbital rhytids at maximal contraction and rest when evaluated independently by investigator and participant (P.001). Also at day 2, the improvement with abobotulinumtoxinA was better than that with onabotulinumtoxinA for the primary end point of maximal contraction graded by the investigator, although this did not reach statistical significance (P=.21); by day 4, the greater improvement achieved with abobotulinumtoxinA reached statistical significance (P=.02) and remained superior at day 6 (P=.02). The primary findings were strengthened by similar results in the secondary end points of patient self-grade at maximal contraction and at rest and of investigator grade at rest.

Conclusions: In conclusion, both abobotulinumtoxinA and onabotulinumtoxinA achieved statistically significant onset of action at day 2. This improvement was seen in all end points, with abobotulinumtoxinA demonstrating a trend toward greater improvement than onabotulinumtoxinA at day 2 and a statistically significant greater improvement at days 4 and 6 when looking at maximal contraction.

Publication Date: June 1, 2012

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

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The role of botulinum toxin type B (Myobloc) in the treatment of hyperkinetic facial lines

Publication Number: 14504489

Botulinum toxin type B was studied for the management of hyperkinetic facial lines. It showed clinical longevity of up to 12 weeks on subjective rating scales and 8 weeks on objective rating scales. Botulinum toxin type B has shown relative safety but can have autonomic side effects at higher total doses, which limits the possibility of continued dose escalation. Although these findings may preclude its use as a primary modality for the use in hyperkinetic facial lines, botulinum toxin type B still has a role in the treatment of the aesthetic patient and is yet another tool in the armamentarium of aesthetic practitioners.

Publication Date: October 9, 2003

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

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A randomized, multicenter study of the safety and efficacy of Dermicol-P35 and non-animal-stabilized hyaluronic acid gel for the correction of nasolabial folds

Publication Number: 18086061

Background: Non-animal-stabilized hyaluronic acid (NASHA) offers longer-lasting cosmetic improvement and reduced risk of hypersensitivity and requires less injection volume than bovine collagen-derived dermal fillers. Porcine collagen-derived Dermicol-P35 has low immunogenicity and has the potential to provide durability at least equivalent to that of NASHA.

Objective: The objective was to evaluate the efficacy and safety of Dermicol-P35 and NASHA for correction of nasolabial folds (NLFs).

Methods and materials: A total of 149 subjects with moderate NLFs were randomized to receive Dermicol-P35 and NASHA on contralateral sides of the face. If needed, subjects could receive a repeat injection 2 weeks later to obtain an optimal cosmetic result (OCR).

Results: Significant (p<.001) improvement in the Modified Fitzpatrick Wrinkle Scale scores relative to screening was observed after treatment with Dermicol-P35 and NASHA. Relative to the OCR visit, mean scores increased (p<.001) over time, but there were no significant differences between treatments (+0.39 and +0.37 at 6 months; p=.626). Greater proportions of subjects experienced swelling, bruising, and pain at the NASHA site. Several subjects had more induration at the Dermicol-P35 site. There was no evidence of any adverse immunologic effect. Conclusion: The effectiveness of Dermicol-P35 is maintained for at least 6 months and is equivalent to NASHA for the correction of NLFs.

Publication Date: December 1, 2007

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

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Effect of homeopathic Arnica montana on bruising in face-lifts: results of a randomized, double-blind, placebo-controlled clinical trial

Publication Number: 16415448

Objectives: To design a model for performing reproducible, objective analyses of skin color changes and to apply this model to evaluate the efficacy of homeopathic Arnica montana as an antiecchymotic agent when taken perioperatively.

Methods: Twenty-nine patients undergoing rhytidectomy at a tertiary care center were treated perioperatively with either homeopathic A. montana or placebo in a double-blind fashion. Postoperative photographs were analyzed using a novel computer model for color changes, and subjective assessments of postoperative ecchymosis were obtained.

Results: No subjective differences were noted between the treatment group and the control group, either by the patients or by the professional staff. No objective difference in the degree of color change was found. Patients receiving homeopathic A. montana were found to have a smaller area of ecchymosis on postoperative days 1, 5, 7, and 10. These differences were statistically significant (P<.05) only on postoperative days 1 (P<.005) and 7 (P<.001). Conclusions: This computer model provides an efficient, objective, and reproducible means with which to assess perioperative color changes, both in terms of area and degree. Patients taking perioperative homeopathic A. montana exhibited less ecchymosis, and that difference was statistically significant (P<.05) on 2 of the 4 postoperative data points evaluated.

Publication Date: February 1, 2006

Authors: Brook M Seeley, Andrew B Denton, Min S Ahn, Corey S Maas

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Efficacy and safety of and patient satisfaction with injectable hyaluronic acid with 0.3% lidocaine hydrochloride for the treatment of superficial perioral lines or superficial lateral canthal lines

Publication Number: 24118510

Background: It is commonly requested that perioral and lateral canthal rhytides, which result from extrinsic and intrinsic factors, be rejuvenated.

Objective: To valuate the safety and efficacy of and patient satisfaction with injectable hyaluronic acid (HA) with 0.3% lidocaine hydrochloride in reducing superficial, vertical perioral wrinkles and superficial, horizontal, lateral canthal rhytides.

Materials and methods: This was a two-center, evaluator-masked, 180-day study in which 40 patients with moderate to severe superficial, vertical perioral lines or superficial, horizontal, lateral canthal lines were treated at their baseline visit with up to three 0.9-mL syringes of HA (5.5 mg/mL) with 0.3% lidocaine hydrochloride. The investigator and a blinded evaluator assessed patients 7 days after treatment and then every 30 days after the initial treatment session for 180 days.

Results: Subjects experienced statistically significant improvement in their superficial, vertical perioral lines and superficial, horizontal, lateral canthal lines and maintained those results for 180 and 120 days, respectively. Three patients experienced delayed-onset periocular nodule formation associated with swelling and erythema at sites of injection, which were histologically consistent with a granulomatous reaction to the product.

Conclusion: Injectable HA with a particle size of 350 μm was efficacious and resulted in high patient improvement scores in improving moderate to severe superficial, vertical perioral lines and superficial, horizontal, lateral canthal lines. Three of the 40 enrolled patients demonstrated granuloma formation.

© 2013 by the American Society for Dermatologic Surgery, Inc. Published by Wiley Periodicals, Inc.

Publication Date: November 1, 2013

Authors: Sabrina G Fabi, Jason P Champagne, Kartik D Nettar, Corey S Maas, Mitchel P Goldman

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A novel, conformable, rapidly setting nasal splint material: results of a prospective study

Publication Number: 12633213

Objective: To determine if a fiberglass splint material (3M Scotchcast, St Paul, Minn; Smith & Nephew, Inc, Charlotte, NC) serves as a better nasal cast than Aquaplast (Smith & Nephew, Inc) based on the criteria of total preparation time, ease of use, conformability, adhesion, and patient acceptability.

Design: Prospective randomized comparison study with statistical analysis.

Setting: University-based division of a facial plastic surgery private clinic.

Patients: Sixteen consecutive patients desiring a functional and aesthetic improvement underwent open structure rhinoplasty with lateral osteotomies. No patients withdrew because of adverse effects.

Intervention: Half of the patients were randomized to the study group (fiberglass splint material) and half to the control group (Aquaplast). Each patient was fitted with the appropriate casting material at the conclusion of the rhinoplasty procedure. Data were collected with respect to total preparation time, ease of use, conformability, and adhesion. Each patient was asked to evaluate the cast for level of comfort after 1 week.

Results: There were no significant differences between study groups for adhesion (P =.18) and conformability (P =.35). Patient acceptability was good or excellent in both study groups. The fiberglass splint material was significantly easier to use (P<.001) and required less total preparation time (P<.001). The mean total preparation time for the Aquaplast and fiberglass splint materials were, respectively, 7 minutes 32 seconds and 2 minutes 37 seconds. Conclusions: Compared with the commonly used nasal splinting material Aquaplast, fiberglass splint material is not significantly more adhesive, conformable, or comfortable for the patient. Fiberglass splint material is significantly easier to use and requires less total preparation time than Aquaplast. These differences may provide advantages in the immediate postoperative period and for the long-term success of rhinoplasty surgery.

Publication Date: March 1, 2003

Authors: Min S Ahn, Corey S Maas, Nathan Monhian

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Use of BioGlue surgical adhesive for brow fixation in endoscopic browplasty

Publication Number: 12633213

Objective: To determine the efficacy, longevity, and safety of BioGlue Surgical Adhesive for periosteal fixation in endoscopic browlifts.

Methods: Retrospective review of 80 patients who underwent endoscopic browlift using BioGlue as the primary means of periosteal fixation. Visits were categorized as preoperative, 1 to 2 months, 3 to 6 months, and 7 to 12 months, and photographs of the first 15 patients were evaluated for change in brow position at each of these visits. Brow position was measured at the lowest brow hairs at the midpupillary and lateral canthus positions. Follow-up was 3 months to 3 years.

Results: All of the first 15 patients were included in the 1- to 2-month postoperative grouping, 13 in the 3- to 6-month grouping, and 10 in the 7- to 12-month grouping. At all postoperative visits, brow elevation was significantly maintained during 12-month follow-up. Revision has been required in only 1 of 80 patients to date.

Conclusions: BioGlue is an effective and safe method of maintaining brow position in endoscopic browplasty. Brow elevation achieved using BioGlue was significantly maintained during the 7- to 12-month postoperative period. Tissue adhesives such as BioGlue have the potential to become significant adjuncts in facial plastic surgery and warrant more critical evaluation.

Publication Date: December 9, 2005

Authors: Min S Ahn, Corey S Maas, Nathan Monhian

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Dorsal onlay cartilage autografts: comparing resorption in a rabbit model

Publication Number: 12756118

Objective: To compare the resorption characteristics of dorsal onlay cartilage autografts from the septum, auricle, and rib.

Methods: Fourteen New Zealand white rabbits underwent harvesting of equal-sized septal, auricular, and costal cartilage grafts free of perichondrium. All autografts were implanted subcutaneously on the nasal dorsum and then removed after 3 months. Graft mass, chondrocyte density, and histologic features from hematoxylin-eosin-stained sections were compared before and 3 months after implantation.

Results: At 3 months after implantation, septal cartilage grafts averaged 30.8% resorption by weight, followed by auricular (23.1%) and costal (7.6%) cartilage. All 3 groups demonstrated similar changes in chondrocyte density and minor calcification at 3 months. There was no evidence of necrosis or inflammatory changes in any of the specimens.

Conclusions: Although the septum is often the preferred source of autogenous cartilage for nasal reconstruction, short-term resorption of septal cartilage appears to be higher for dorsal onlay grafts. The low resorption of costal cartilage may be due in part to its compact shape compared with septal and auricular cartilage. It remains to be seen whether these differences in resorption persist in the long term.

Publication Date: June 1, 2003

Authors: Bruce V Lattyak, Corey S Maas, Jonathan M Sykes

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Botulinum toxin type B (MyoBloc) in the management of hyperkinetic facial lines

Publication Number: 12075218

Objective: Our goal was to evaluate the safety and efficacy of botulinum toxin type B (BTX-B) in the management of hyperfunctional facial lines.

Study design and setting: Twenty-four patients from an academic faculty practice were treated with 400 to 800 units BTX-B in the corrugator, orbicularis oculi, or frontalis. Patients were evaluated with the Wrinkle Improvement Score (WIS) and Rated Numeric Kinetic Line Scale (RNKLS) and questioned about side effects and pain. Evaluations were made at 1, 2, 4, 8, and 12 weeks.

Results: Onset of effect was within 72 hours. WIS and RNKLS for all sites were statistically better after treatment, with the effect lasting 8 weeks. In general, patients noted a moderate improvement (grade 2) on WIS and a 2-point improvement on RNKLS. Injection was more painful than that of BTX-A. There were no complications.

Conclusion: BTX-B is a safe and effective technique to eliminate wrinkles. Further studies are needed to elucidate dosage and duration.

Significance: BTX-B is stable for prolonged periods of time, requires no preparation before use, and is antigenetically distinct from BTX-A.

Publication Date: May 1, 2002

Authors: Alexander L Ramirez, Jay Reeck, Corey S Maas

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Determination of shear strength of periosteum attached to bone with BioGlue Surgical Adhesive

Publication Number: 18794409

Objective: To determine the shear strength of BioGlue Surgical Adhesive (Cryolife Inc, Kennesaw, Georgia) for use in periosteal fixation in endoscopic browplasty.

Methods: In a controlled design, the shear strength of periosteal attachment to native bone and that of dissected periosteum affixed to bone with BioGlue surgical adhesive was physiologically determined. Twenty-one periosteum and bone samples were harvested from 3 human cadavers. These samples were tested for maximum shear strength using an Instron Model 5500 universal materials testing machine. Native samples consisted of periosteum still attached to the bone surface, while BioGlue samples consisted of dissected periosteum reattached to the bone surface using BioGlue surgical adhesive. The maximum shear strength attained for each sample was recorded and used to determine if native samples differed from those using BioGlue surgical adhesive.

Results: The mean (SD) maximum shear strength values obtained during testing were 57.8 (31.7) kPa and 45.9 (27.4) kPa (589.4 [323.3] gram force [gf]/cm(2) and 468.0 [279.4] gf/cm(2)) for native (n=8) and BioGlue (n=9) samples, respectively. There was no statistical difference between the native and BioGlue samples (P> .05) using analysis of variance.

Conclusion: This study demonstrates that the adhesive properties of BioGlue are similar to the strength of attachment of native periosteum to bone and supports the use of BioGlue as an alternative method of fixation for use in endoscopic brow-lifting.

Publication Date: October 1, 2008

Authors: Douglas M Sidle, Corey S Maas

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Botulinum neurotoxins and injectable fillers: minimally invasive management of the aging upper face

Publication Number: 17383508

Attitudes on the use of injectable agents for rejuvenation of the face have changed dramatically over the last decade. This is particularly true for the upper third of the face, where the impact of the use of Botox had its first application. In the author’s opinion, no technique, device, or pharmaceutical has had a greater impact on the aesthetic surgery than the now widely used botulinum toxin as an injectable agent.

Publication Date: April 12, 2007

Authors: Corey S Maas

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Scarless lip rehabilitation for the adynamic lip

Publication Number: 12707655

Objective: Paralysis of the marginal mandibular branch of the facial nerve can be a debilitating condition resulting in compromised speech and oral incompetence. We describe a static procedure performed to address the functional and cosmetic deficits seen with an adynamic lip.

Methods: Three patients with complete facial nerve paralysis were evaluated after the scarless lip rehabilitation, a modification of the traditional wedge resection of the lower lip. The procedure is novel in that the removal of lip laxity and advancement of the contralateral innervated lip is achieved without an external facial skin incision.

Results: All 3 patients in the study reported improvement in oral competence and lip symmetry; however, articulation was less consistently affected. All 3 patients were able to drink from a glass without leaking from their oral commissure. No complications were seen in this series of patients.

Conclusion: Oral incompetence and asymmetry are often the overlooked sequelae from complete facial nerve paralysis. Scarless lip rehabilitation of the adynamic lip is a novel, safe, and effective means to improve these functional and aesthetic deficits.

Publication Date: April 4, 2003

Authors: Dov C Bloch, Michael C Scheuller, Corey S Maas

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Dr. Corey S. Maas

World Renowned Facial Plastic Surgeon