Mid-Face Volumization With Hyaluronic Acid: Injection Technique and Safety Aspects from a Controlled, Randomized, Double-Blind Clinical Study

April 2017 | Volume 16 | Issue 4 | Original Article | 351 | Copyright © 2017

Welf Prager MD,a Karla Agsten MD,b Maria Kravtsov MSc,c and Prof. Martina Kerscher MDd

aPrager & Partner Dermatologische Praxis, Hamburg, Germany bSCIderm GmbH, Hamburg, Germany cAnteis S.A, Geneva, Switzerland dUniversity of Hamburg, Hamburg, Germany

Abstract

BACKGROUND: Injection of hyaluronic acid (HA) volumizing fillers in the malar area is intended for rejuvenation of the mid-face. The choice of products, depth, and technique of injection depends on the desired level of volume enhancement and practitioners’ preferences.

OBJECTIVE: To describe a volumizing injection technique in the scope of a controlled, randomized, double-blind, single-center, split-face clinical study. Materials & Methods: A total of 45 subjects with bilateral symmetrical moderate to severe volume loss in the malar area received a single 2 mL injection of CPM®-26 (Cohesive Polydensified Matrix®) on one side and VYC®-20 (VYCROSS®) on the contralateral side of the face. The same injection technique was applied for both sides of the face. Use of anesthetics, overcorrection, and touch-ups were not permitted. The investigator completed a product satisfaction questionnaire. Adverse events (AE) and injection-site reactions (ISRs) were reported during the study.

RESULTS: The products were placed at the epiperiosteal depth in 88.9% (n=40), at the subdermal depth in 8.9% (n=4) and at both levels in 2.2% (n=1) of subjects. Fanning technique using cannulae was applied in most cases (97.8%, n=44). Results of the investigator satisfaction questionnaire allowed to characterize CPM-26 in comparison to other volumizing gels. Both study products were generally well tolerated. Local reactions were transient and of mild to moderate intensity, with the most frequent ones being redness, pain, and swelling.

CONCLUSION: Adequate injection technique in volumizing treatments is essential to create a natural aesthetic rejuvenation while respecting the safety aspect of the procedures. A 22G blunt cannula used with CPM-26 was preferred due to an easier and a more homogeneous distribution of the product. The investigator also appreciated CPM-26 for its ease of injection, positioning, lifting, and volumizing capacity.

J Drugs Dermatol. 2017;16(4):351-357.

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INTRODUCTION

Volumetric changes in the mid-face occur naturally as the human face ages. They are characterized by the atrophy and gravity-induced repositioning of facial fat and skeletal remodeling.1-4 The resulting flattening of the convex facial contours is translated into a sad and tired appearance encouraging patients to seek aesthetic procedures, such as treatment with hyaluronic acid (HA) volumizing fillers.5 These products should be cohesive and robust, as they give structural support to soft tissues and thus elevate the projection of the cheeks and cheekbones. Enhanced mid-facial contours majorly contribute to the global rejuvenation, as the lifting effect also impacts the adjacent areas, resulting in smoothening of the nasolabial folds and the nasojugal groove.2,6,7 Various HA volumizing fillers produced with different technologies are currently available on the market. They differ in composition, duration of effect, palpability, administration techniques, safety, and other factors.8CPM®-26 (Modélis® SHAPE, Anteis S.A, Geneva, Switzerland; commercialized as Belotero® Volume, Merz Pharmaceuticals GmbH, Frankfurt, Germany) is a CE-marked gel manufactured with the patented Cohesive Polydensified Matrix® (CPM®) technology. It is composed of 26 mg/ml HA from biofermentation origin cross-linked with 1,4-butanediol diglycidylether (BDDE). The product presents variable densities within the gel, where denser areas ensure volumizing effect and less dense areas ensure cohesivity of the matrix. These properties allow the gel to be easily extruded through the needle/cannula during the injection and prevent it from migrating once implanted. CPM-26 is also characterized by the plasticity of the gel, which allows the practitioner to mold and sculpt the product as required in order to meet the individual needs of each patient.9 VYC®-20 (Juvéderm® VOLUMA®, Allergan Inc., Pringy, France) is a 20 mg/ml bacteria-sourced HA gel manufactured with the

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