Responder Rates: • Subject satisfaction (age, social confidence, and psychological well-being) appeared to correlate with efficacy as assessed by blinded, independent raters Product usage that led to higher degrees of subject satisfaction: Maximizing Pan-facial Aesthetic Outcomes: Findings and Recommendations from the HARMONYTM Study Michael Kaminer, MD1; Joel L. Cohen, MD2; Vic Narurkar, MD3; Ava Shamban, MD4; Phil Werschler, MD5; Garrett T. Shumate, BS6; Conor J. Gallagher, PhD6 1SkinCare Physicians, Inc., Chestnut Hill, MA, USA; 2AboutSkin Dermatology and DermSurgery, Englewood, CO, USA; 3Bay Area Laser Institute, San Francisco, CA, USA; 4AVA MD, Santa Monica, CA, USA; 5University of Washington, School of Medicine, Seattle, WA, USA; 6Allergan plc, Irvine, CA • Highest improvement was achieved with more volume in the zygomaticomalar and less in the anteromedial cheek • More overall volume did not translate into a higher improvement for the patient Fall Clinical Dermatology Conference, Las Vegas, October 12-15, 2017 ACKNOWLEDGMENTS: This study was funded by Allergan plc. Medical writing and editorial assistance was provided to the authors by Cactus Communications, and was funded by Allergan plc. All authors met the ICMJE authorship criteria. Neither honoraria nor other form of payments were made for authorship. FINANCIAL DISCLOSURES: M Kaminer received consulting fees from Cytrellis, Soliton, and Zeltiq; has ownership in Cytrellis and Soliton; received honoraria from Cutera and Soliton; and received funding from Allergan, Cytrellis, Soliton, Sciton, Cutera, Cynosure, Galderma, and L’Oreal. JL Cohen and P Werschler serve as investigators for Allergan plc. V Narurkar received consulting fees from Allergan plc, Philips, and Revance; served on the advisory boards for Cabocon Aesthetics and Clarisonic; has ownership in the Cosmetic Boot Camp LLC; and received funding from Allergan plc, Merz Aesthetics, Solta Medical, Myoscience, Polyremedy LLC, and Syneron Candela. Ava Shamban is an investigator for Allergan plc, Medicis, and Galderma; and a consultant for Allergan plc and Merz. GT Shumate and CJ Gallagher are employees of Allergan plc and may own stock or stock options in the company. • Aesthetic medicine has evolved from targeting individual treatment areas to a more global approach of facial rejuvenation (i.e. pan-facial treatment). • A multimodal approach to pan-facial aesthetic treatment has not been systematically evaluated in controlled clinical studies. As a result, there is a paucity of universal best practices. • HARMONYTM was the first clinical trial to evaluate the impact of combined treatment with hyaluronic acid fillers, onabotulinumtoxinA, and bimatoprost 0.03% using a range of validated measures • Objective: Understand the treatment strategies that enabled the clinical sites with the highest improvements on the Primary Endpoint (FACE-Q Satisfaction with Face Overall) to achieve incrementally greater results, as compared to those sites with the lowest improvements BACKGROUND CONCLUSIONS Study Design • Data from the clinical sites with the lowest (2 sites) and highest (2 sites) improvements based on the primary endpoint (FACE-Q Satisfaction with Face Overall) were separated to understand “how” the highest improvements were achieved • Note that all clinical sites exhibited a significant improvement • A comparative analysis of the treatment characteristics (e.g. product selection, injection location, and injection volume) was performed to understand the factors enabling the highest performing sites to achieve incrementally greater improvements. Subjects • Evaluation indicated similarity across most of the demographic characteristics: Characteristic HIGHEST SITES LOWEST SITES Gender All Female All Female Age (mean) 51.8 years 52 years Fitzpatrick Skin Phototype (mean) 2.9 3.2 • Evaluation indicated similar baselines across most of the endpoints: Endpoint LOWEST SITES (mean) HIGHEST SITES (mean) FACE-Q: Satisfaction with Facial Appearance Overall 22.7 22.4 FACE-Q: Aging Appearance Appraisal 19.2 18.5 FACE-Q: Social Confidence Scale 22.6 22.1 FACE-Q: Psych Well-Being Scale 28.4 27.8 Self-Perception of Age (years) 0.3 0.5 Overall Mid-Face Volume Deficit 3.0 3.1 Nasolabial Folds (NLFSS) 2.5 2.4 Oral Commissures (OCSS) 2.1 2.1 Perioral Lines (POLSS) 1.8 1.9 Glabellar Line Severity at Maximum Frown (FWS) 2.6 2.2 Crow’s Feet Line Severity (FWS) 2.4 2.3 Eyelash Prominence (GEA) 1.9 1.6 MATERIALS AND METHODS RESULTS Efficacy Outcomes Voluma XC: Midface Category LOWEST SITES (mean) HIGHEST SITES (mean) DIFFERENCE (%) FACE-Q: Satisfaction with Facial Appearance 9.1 13.8 52 FACE-Q: Aging Appearance Appraisal -4.3 -8.7 103 FACE-Q: Aging Appearance Appraisal (Visual Analog Scale) -3.6 -6.1 70 FACE-Q: Social Confidence Scale 4.2 7.3 75 FACE-Q: Psych Well-being Scale 5.1 8.2 60 Self-Perception of Age -3.4 -6.3 89 Appearance of Periorbital Lines -10.4 -14.2 37 Global Aesthetic Improvement (Subject) 1.5 1.7 16 Global Aesthetic Improvement (Evaluating Investigator) 1.1 1.6 55 Category LOWEST SITES (mean) HIGHEST SITES (mean) DIFFERENCE (%) Glabellar Lines (max frown) -1.70 -1.21 -29 Eyelash Prominence 1.90 1.47 -22 Crow’s Feet Lines (max smile) -0.88 -1.37 63 MidFace -1.20 -1.95 62 Nasolabial Folds -0.90 -1.32 46 Perioral Lines -0.72 -1.26 75 Oral Commissures -0.68 -1.32 92 Location HIGHEST SITES Mean volume injected per subject (% of subjects treated) LOWEST SITES Mean volume injected per subject (% of subjects treated) Zygomaticomalar V1, V2 1.3 (100%) 1.0 (90%) Anteromedial Cheek V3 0.9 (100%) 1.2 (90%) Submalar V4 0.9 (53%) 0.7 (75%) Overall Midface Total V1-V4 2.7 (100%) 2.9 (90%) Ultra XC & Ultra Plus XC Ultra XC & Ultra Plus XC Layering Use of Touch-Ups Location Product HIGHEST SITES Mean volume injected per subject (% of subjects treated) LOWEST SITES Mean volume injected per subject (% of subjects treated) Radial Cheek Total Ultra XC + Ultra Plus XC 0.0 (0%) 0.8 (30%) Ultra XC 0.0 (0%) 0.5 (30%) Ultra Plus XC 0.0 (0%) 0.7 (15%) Perioral Region Total Ultra XC + Ultra Plus XC 0.8 (79%) 0.6 (55%) Ultra XC 0.7 (68%) 0.6 (55%) Ultra Plus XC 1.0 (16%) 0.3 (15%) Overall Use Total Ultra XC + Ultra Plus XC 4.0 (100%) 3.4 (100%) Ultra XC 3.0 (84%) 1.7 (65%) Ultra Plus XC 2.2 (68%) 2.4 (95%) Location Product HIGHEST SITES Mean volume injected per subject (% of subjects treated) LOWEST SITES Mean volume injected per subject (% of subjects treated) NLF Total Ultra XC + Ultra Plus XC 2.0 (89%) 1.2 (95%) Ultra XC 2.0 (79%) 0.6 (20%) Ultra Plus XC 0.7 (32%) 1.1 (90%) Oral Commissures Total Ultra XC + Ultra Plus XC 0.9 (100%) 1.0 (90%) Ultra XC 1.0 (40%) 0.5 (65%) Ultra Plus XC 0.7 (68%) 0.7 (75%) Marionette Lines Total Ultra XC + Ultra Plus XC 1.2 (50%) 1.1 (75%) Ultra XC 0.3 (10%) 0.5 (40%) Ultra Plus XC 1.1 (53%) 0.8 (75%) Location HIGHEST SITES % of sub that rec’d both products (% rec’d both products in same visit) LOWEST SITES % of sub that rec’d both products (% rec’d both products in same visit) Nasolabial Fold 17.6 (11.8) 15.8 (5.3) Marionette Lines 20.0 (10.0) 53.3 (53.3) Oral Commissures 5.3 (0.0) 55.6 (33.3) Radial Cheek 0.0 (0.0) 50.0 (50.0) Perioral 6.7 (0.0) 27.2 (18.2) • Highest improvement was achieved when using only one product per location Product HIGHEST SITES Mean volume injected per subject (% of subjects treated) LOWEST SITES Mean volume injected per subject (% of subjects treated) Voluma XC 1.3 (53%) 0.9 (70%) Ultra XC 1.8 (58%) 0.9 (35%) Ultra Plus XC 1.1 (48%) 0.9 (60%) • Highest improvement was achieved using more touch-up volume for all fillers Scan to obtain PDF of poster • Highest sites exhibited greater improvement across all PROs • Highest sites had less improvement in glabellar lines and eyelash prominence, which could be attributed to baseline differences • Highest sites exhibited greater improvement in all other filler and toxin related outcomes Category Ultra XC Ultra Plus XC Ultra XC + Ultra Plus XC Voluma XC Zygomaticomalar Anteromedial Cheek Lower Face NLF Marionette Lines Oral Commissure Radial Cheek Perioral Touch Up Key: Highest sites used more volume Highest sites used less volume Product preferred by both highest and lowest sites Product Overlay: • Highest improvements were achieved when using only one product per location Highest Sites Lowest Sites Perceived Age Perceived Age 6.3 years younger 3.4 years younger Midface: Midface: Lower face: Lower face: 2.7 mL Voluma XC V1 + V2 = 1.3 mL V1 + V2 = 1.0 mL Nasolabial Folds Nasolabial Folds Marionette lines Marionette lines Oral commissures Oral commissures Perioral lines Perioral lines V3 = 0.9 mL V3 = 1.2 mL 2.0 mL combined 1.2 mL combined 1.2 mL combined 1.1 mL combined 0.9 mL combined 1.0 mL combined 0.8 mL combined 0.6 mL combined 2.9 mL Voluma XC 4.0 mL Ultra XC + Ultra Plus XC 3.4 mL Ultra XC + Ultra Plus XC To obtain a PDF of this poster: Scan the QR code OR Visit www.allergancongressposters.com/516224 Charges may apply. No personal information is stored. Enter a valid e-mail to send this QR code or click to download. Please ensure that qrcode@allergancongressposters.com has been added to your safe senders list or spam filter. FC17PosterAllerganKaminerMaximizingPanFacialAestheticOutcomes.pdf