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A Randomized, Evaluatorblinded, Controlled Study of The A Randomized, Evaluator-Blinded, Controlled Study of the Effectiveness and Safety of Small Gel Particle Hyaluronic Acid for Lip Augmentation † ‡ § RICHARD G. GLOGAU, MD,* DAVID BANK, MD, FREDRIC BRANDT, MD, SUE ELLEN COX, MD, ¶ †† ‡‡ LISA DONOFRIO, MD, JEFFREY DOVER, MD,** STEVEN GREKIN, DO, IRA LAWRENCE, MD, ‡‡ §§¶¶ XIAOMING LIN, MS, RN, MARK NESTOR, MD, PHD, AVA SHAMBAN, MD,*** ††† ‡‡‡ §§§ DANIEL STEWART, DO, ROBERT WEISS, MD, ROBERT A. AXFORD-GATLEY, MD, §§§ ¶¶¶ MICHAEL J. THEISEN,PHD, AND STACY SMITH,MD OBJECTIVES To assess the effectiveness and safety of small gel particle hyaluronic acid (SGP-HA) for lip augmentation. METHODS Adults (n = 180; aged 18–65) scoring 1 (very thin) to 2 (thin) on the 5-point validated Medicis Lip Fullness Scale (MLFS) for the upper or lower lip were randomized (3:1) to SGP-HA ( 1.5 mL/lip) or no treatment. Co-primary effectiveness end points were blinded-evaluator MLFS score for upper or lower lip at week 8. Secondary end points (MLFS score, independent photographic review, Global Aesthetic Improvement Scale [GAIS], safety assessments) were measured throughout the study. RESULTS Statistically significantly more MLFS responders ( 1 grades of MLFS improvement at week 8) received SGP-HA (93% combined upper and lower lip responders [95% upper lip; 94% lower lip]) than no treatment (29% combined; p < .001). SGP-HA improved self-assessed combined lip GAIS (97% week 8; 74% week 24) significantly more than no treatment (0% throughout; p < .001). The SGP-HA group reported anticipated swelling (58%) and bruising (44%), 88% mild or 11% moderate severity, without unanticipated device adverse events. CONCLUSIONS SGP-HA is highly effective and well tolerated for lip augmentation. Statistically significant improvement was evident based on the MLFS at 8 weeks, with visible results reported in the majority of participants 6 months after treatment. Medicis Aesthetics Inc. (Scottsdale, AZ) provided funding and materials for this study. Canfield loaned photographic equipment. Complete Healthcare Communications, Inc. (Chadds Ford, PA) provided editorial support. Dr. Glogau is a consultant to Medicis and Allergan. Dr. Nestor is a consultant to Medicis. Dr. Shamban serves on the advisory board to Medicis. urable, nonpermanent dermal fillers, such as lips and perioral areas, including increasing the D hyaluronic acid (HA) products and formerly overall volume of the lip or enhancing the vermilion collagen, are used in procedures for augmenting the border, and sculpting and accentuating lip † *Richard G. Glogau, MD, Inc., San Francisco, California; Center for Dermatology, Cosmetic and Laser Surgery, ‡ § Mount Kisco, New York; Dermatology Research Institute LLC, Coral Gables, Florida; Aesthetic Solutions, Chapel ¶ Hill, North Carolina; The Savin Center, New Haven, Connecticut; **SkinCare Physicians, Chestnut Hill, †† ‡‡ §§ Massachusetts; Grekin Skin Institute, Warren, Michigan; Medicis Aesthetics, Scottsdale, Arizona; Center for ¶¶ Clinical and Cosmetic Research, Aventura, Florida; Department of Dermatology, University of Miami Miller School of ††† Medicine, Miami, Florida; ***Ava T Shamban, MD, Inc., Santa Monica, California; Michigan Center for Skin Care ‡‡‡ §§§ Research, Clinton Township, Michigan; Maryland Laser Skin and Vein Institute, Hunt Valley, Maryland; Complete ¶¶¶ Healthcare Communications, Inc., Chadds Ford, Pennsylvania; Dermatology and Consulting, Cardiff, California © 2012 by the American Society for Dermatologic Surgery, Inc. Published by Wiley Periodicals, Inc. ISSN: 1076-0512 Dermatol Surg 2012;38:1180–1192 DOI: 10.1111/j.1524-4725.2012.02473.x 1180 GLOGAU ET AL – contours.1 3 The clinical effectiveness of filler agents suppuration at the injection site required drainage in is judged on aesthetic outcomes, including lip one patient and were self-limiting with warm com- fullness, smoothness, softness and flexibility, and presses and topical corticosteroid cream in a second – absence of nodules.4 7 patient. Many reports, including an open-label study, in the literature describe the effectiveness of Restylane (Medicis Aesthetics Inc., Scottsdale, AZ) HA in lip augmentation.6,12,13 In a small, open-label is a nonanimal-source small gel particle hyaluronic pilot study, 89% (16/18) of patients treated with acid (SGP-HA) that the U.S. Food and Drug SGP-HA had greater lip fullness, as measured by an Administration (FDA) has approved for mid to deep improvement of one grade or more on the validated dermal implantation for the correction of moderate Medicis Lip Fullness Scale (MLFS) in both lips after to severe facial wrinkles and folds.8 It is supplied as 8 weeks.13 This prespecified improvement criterion a clear gel formulation of small particles of HA in a was met in 18 (100%) patients for the upper lip and single-use syringe. The physical characteristics and in 16 (89%) for the lower lip. The clinical relevance structure of an HA soft tissue filler and its rheolog- of this MLFS improvement was consistent with ical properties are established during the manufac- improved scores on the subjective Global Aesthetic turing process. SGP-HA is formed by passing Improvement Scale (GAIS). No treatment-related stabilized gel through screens with a specific pore adverse events (AEs) were reported. size, producing well-defined gel particles that are uniform in shape and diameter. This manufacturing This article presents the results of a randomized, no method coupled with other variables such as HA treatment–controlled, evaluator-blinded study that concentration and percentage of cross-linking results assessed the safety and effectiveness of SGP-HA for in a gel particle that is stiff but elastic, capable of soft tissue lip augmentation. resisting deformation and maintaining its original shape when subjected to external and skin tension – forces.9 11 Such characteristics may play an impor- Methods tant role in predicting how an HA filler may behave Patients in the skin and its ability to provide structural support, definition, volume, and lift. Eligible patients were adult men and women no older than 65 seeking lip augmentation at 12 The effectiveness and safety of SGP-HA in the investigational centers and scoring 1 or 2 on the 5- treatment of facial wrinkles and folds was evaluated point MLFS (1 = very thin, 5 = very full) for the in three prospective, randomized comparator trials upper and lower lips in patients with Fitzpatrick skin involving 430 treated patients.8 The injection of type I, II, or III or for one or both lips in patients SGP-HA was found to be as effective as the with skin type IV, V, or VI, as assessed at baseline by correction of moderate to severe facial folds and the treating investigator. Participants were required wrinkles as a bovine collagen product (previously in to abstain from any other facial plastic surgery or common use, but no longer available in the United cosmetic procedures during the 9-month study States) and another HA dermal filler. period. Exclusion criteria included a history of severe or multiple allergies, including allergy or A retrospective review of 685 patients treated with hypersensitivity to injectable HA gel or local anes- SGP-HA for lip augmentation in clinical practice thetics; history of any disease resulting in edema of found that 61% were satisfied with their results after the face or changes in facial contour during the study 9 months.12 Adverse effects, other than transient period; history of any tissue augmentation therapy injection site erythema and occasional bruising, were or aesthetic facial surgical therapy below the level of rare and easily managed; induration and sterile the lower orbital rim; any contraindication to the 38:7 PART II:JULY 2012 1181 L IP A UGMENTATION WITH SMALL GEL P ARTICLE H YALURONIC A CID implant procedures, including use of anticoagulants; ment, function, sensation, and mass formation). and significant abnormalities of the lips. A central Diaries were dispensed to all patients with instruc- institutional review board (Quorum Review IRB, tions to record daily the extent (none, tolerable, Seattle, WA) approved the study protocol and affects activities, disabling) of bruising, redness, documents. Patients provided written informed swelling, pain, tenderness, itching, and other events consent before being admitted to the study. The around or on the lips for the first 14 days after study was conducted in accordance with the Decla- treatment. Seventy-two hours after treatment, a ration of Helsinki and Good Clinical Practice. safety visit assessed safety parameters and inter- viewed the patient regarding AEs. At weeks 2 and 4 Treatments after treatment, MLFS (treating investigator), GAIS (treating investigator and patient), safety parame- Patients were randomly assigned 3:1 to receive SGP- ters, and AEs were assessed; photographs obtained; HA or no treatment. A centralized randomization and diaries returned (week 2). At weeks 8, 12, 16, system was used to ensure enrollment of a minimum 20, and 24 after treatment, MLFS (live evaluations of 30 patients with darker skin types based on of patients by treating and blinded investigators), classification of Fitzpatrick skin types IV, V, or VI. GAIS (treating investigator and patient), safety Patients randomized to the no-treatment group were parameters, and AEs were assessed, and photo- untreated after screening and baseline assessments graphs were obtained. (described below). Patients randomized to SGP-HA were treated initially with SGP-HA for optimal lip The MLFS is a validated, 5-point scale of lip
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