Safety and performance of cohesive polydensified matrix hyaluronic acid fillers with lidocaine in the clinical setting - an open-label, multicenter study

Ulrich Kühne, Jørgen Esmann, Dennis von Heimburg, Matthias Imhof, Petra Weissenberger, Gerhard Sattler, Ulrich Kühne, Jørgen Esmann, Dennis von Heimburg, Matthias Imhof, Petra Weissenberger, Gerhard Sattler

Abstract

Cohesive polydensified matrix (CPM®) hyaluronic acid fillers are now available with or without lidocaine. The aim of this study was to investigate the safety and performance of CPM® fillers with lidocaine in the clinical setting. In an open-label, prospective, postmarketing study, 108 patients from seven sites in Germany and Denmark were treated with one or more lidocaine-containing CPM® fillers. Performance was assessed using the Merz Aesthetics Scales® (MAS). Pain was rated on an 11-point visual analog scale. Patients' and physicians' satisfaction as well as adverse events were recorded. Improvements of ≥1-point on MAS immediately after and 17 days posttreatment were observed in ~90% of patients compared with baseline. All investigators assessed ejection force, product positioning, and performance as similar or superior to the respective nonlidocaine products. Overall, 94% of investigators were satisfied with the esthetic outcomes and were willing to continue using the products. All patients except one were satisfied with the results, and all were willing to repeat the treatment. Mean pain scores were low during (<3.0) and after injection (<0.6). Except for one case of bruising, all adverse events were mild to moderate. CPM® fillers with lidocaine are safe and effective for a wide range of esthetic facial indications.

Keywords: Belotero; Esthélis; Fortélis; Modélis; cohesive polydensified matrix; dermal fillers.

Conflict of interest statement

DisclosureUlrich Kühne has acted as a speaker for Merz, Galderma, and Procutis and has conducted clinical trials for Merz. Jørgen Esmann reports no conflicts of interest in this work. Dennis von Heimburg has acted as a speaker and consultant for Merz. Matthias Imhof has acted as a consultant, speaker, and investigator in clinical trials for Merz. Petra Weissenberger is an employee of Merz. Gerhard Sattler has acted as a speaker for Merz, Allergan, and Galderma, and the Rosenparkklinik has received research support and has conducted clinical trials for Merz, Galderma, and Allergan. The authors report no other conflicts of interest in this work.

Figures

Figure 1
Figure 1
Mean improvements on Merz Aesthetics Scales® (MAS) compared with baseline scores at V1 (postinjection) and V2 (preinjection) by treated area for Soft-L. Abbreviations: Soft-L, Soft Lidocaine; NLF, nasolabial folds.
Figure 2
Figure 2
Mean improvements on Merz Aesthetics Scales® (MAS) compared with baseline scores at V1 (postinjection) and V2 (preinjection) by treated area for Basic-L. Abbreviations: Basic-L; Basic Lidocaine; NLF, nasolabial folds.
Figure 3
Figure 3
Mean improvements on Merz Aesthetics Scales® (MAS) compared with baseline scores at V1 (postinjection) and V2 (preinjection) by treated area for Extra/Intense-L. Abbreviations: Extra/Intense-L, Extra/Intense Lidocaine; NLF, nasolabial folds.
Figure 4
Figure 4
Mean improvements on Merz Aesthetics Scales® (MAS) compared with baseline scores at V1 (postinjection) and V2 (preinjection) by treated area for Modélis-L. Abbreviation: Modélis-L, Modélis® Shape Lidocaine.

References

    1. Cohen JL, Dayan S, Brandt FS, et al. Systematic review of clinical trials of small- and large-gel-particle hyaluronic acid injectable fillers for aesthetic soft tissue augmentation. Dermatol Surg. 2013;39(2):205–231.
    1. Lorenc ZP, Fagien S, Flynn TC, Waldorf HA. Review of key Belotero Balance safety and efficacy trials. Plast Reconstr Surg. 2013;132(4 suppl 2):33S–40S.
    1. Prager W, Wissmueller E, Havermann I, et al. A prospective, split-face, randomized, comparative study of safety and 12-month longevity of three formulations of hyaluronic acid dermal filler for treatment of nasolabial folds. Dermatol Surg. 2012;38(7 pt 2):1143–1150.
    1. Buntrock H, Reuther T, Prager W, Kerscher M. Efficacy, safety, and patient satisfaction of a monophasic cohesive polydensified matrix versus a biphasic nonanimal stabilized hyaluronic acid filler after single injection in nasolabial folds. J Dermatol Surg. 2013;39(7):1097–1105.
    1. Micheels P. Fortélis extra resorbable and non-surgical volumising implant of Swiss conception. J Cosmet Surg Med. 2011;6:30–34.
    1. Micheels P, Ascher B, Beilin G, et al. Évaluation clinique de l’efficacité et l’innocuité d’un acide hyaluronique volumateur de technologie CPM® pour le traitement de multiples zones du visage [Clinical evaluation of the efficacy and safety of a volumizing hyaluronic acid with CPM technology for the treatment of multiple areas of the face] Realités Thérapeutiques en Dermato-Vénérologie. 2014;235:1–8.
    1. Gregory I. A study of the clinical effectiveness of a new polydensified monophasic hyaluronic acid dermal filler. J Cosmet Surg Med. 2007;3:32–34.
    1. Sundaram H, Cassuto D. Biophysical characteristics of hyaluronic acid soft-tissue fillers and their relevance to aesthetic applications. Plast Reconstr Surg. 2013;132(4 suppl 2):5S–21S.
    1. Pavicic T. Efficacy and tolerability of a new monophasic, double-cross-linked hyaluronic acid filler for correction of deep lines and wrinkles. J Drugs Dermatol. 2011;10(2):134–139.
    1. Gold M. The science and art of hyaluronic acid dermal filler use in esthetic applications. J Cosmet Dermatol. 2009;8(4):301–307.
    1. Hevia O, Cohen BH, Howell DJ. Safety and efficacy of a cohesive polydensified matrix hyaluronic acid for the correction of infraorbital hollow: an observational study with results at 40 weeks. J Drugs Dermatol. 2014;13(9):1030–1036.
    1. Wollina U. Improvement of tear trough by monophasic hyaluronic acid and calcium hydroxylapatite. J Clin Aesthet Dermatol. 2014;7(10):38–43.
    1. Carruthers A, Carruthers J, Hardas B, et al. A validated grading scale for marionette lines. Dermatol Surg. 2008;34(suppl 2):S167–S172.
    1. Carruthers J, Flynn TC, Geister TL, et al. Validated assessment scales for the mid face. Dermatol Surg. 2012;38(2 Spec):320–332.
    1. Narins RS, Carruthers J, Flynn TC, et al. Validated assessment scales for the lower face. Dermatol Surg. 2012;38(2 Spec No):333–342.
    1. Fabi SG, Champagne JP, Nettar KD, et al. 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. Dermatol Surg. 2013;39:1613–1620.
    1. Philipp-Dormston WG, Hilton S, Nathan M. A prospective, open-label, multicenter, observational, postmarket study of the use of a 15 mg/mL hyaluronic acid dermal filler in the lips. J Cosmet Dermatol. 2014;13:125–134.
    1. Muhn C, Rosen N, Solish N, et al. The evolving role of hyaluronic acid fillers for facial volume restoration and contouring: a Canadian overview. Clin Cosmet Investig Dermatol. 2012;5:147–158.
    1. Goh AS, Kohn JC, Rootman DB, Lin JL, Goldberg RA. Hyaluronic acid gel distribution pattern in periocular area with high-resolution ultrasound imaging. Aesthet Surg J. 2014;34:510–515.
    1. Tran C, Carraux P, Micheels P, Kaya G, Salomon D. In vivo bio-integration of three hyaluronic acid fillers in human skin: a histological study. Dermatology. 2014;228:47–54.
    1. Prager W, Micheels P. A prospective, comparative survey to investigate practitioners’ satisfaction with a cohesive, polydensified-matrix®, hyaluronic acid-based filler gel with and without lidocaine for the treatment of facial wrinkles. J Cosmet Dermatol. 2015;14:124–129.
    1. Royo de la Torre J, Moreno-Moraga J, Isarria MJ, et al. The evaluation of hyaluronic acid, with and without lidocaine, in the filling of nasolabial folds as measured by ultrastructural changes and pain management. J Drugs Dermatol. 2013;12(3):e46–e52.
    1. Moradi A, Shirazi A, Moradi-Poehler J, Turner J, Howell DJ. A blinded, randomized, split-face pilot study of bruising and pain with hyaluronic acid for correction of perioral lines using no lidocaine, lidocaine alone, and lidocaine and epinephrine. Aesthet Surg J. 2015;35:443–455.
    1. Micheels P, Vandeputte J, Kravtsov M. Treatment of age-related mid-face atrophy by injection of cohesive polydensified matrix hyaluronic acid volumizer. J Clin Aesthet Dermatol. 2015;8(3):28–34.
    1. Funt D, Pavicic T. Dermal fillers in aesthetics: an overview of adverse events and treatment approaches. Clin Cosmet Investig Dermatol. 2013;6:295–316.
    1. Sherman RN. Avoiding dermal filler complications. Clin Dermatol. 2009;27(suppl):S23–S32.

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