Clinical Evaluation of a Cross-Linked Hyaluronic Acid Dermal Filler Applied for Facial Augmentation

January 2015 | Volume 14 | Issue 1 | Original Article | 19 | Copyright © 2015

Scott KM Barr MD FRCPC,a Arie Benchetrit MD FRCPC,b Mariusz Sapijaszko MD FRCP,c
and Anneke Andriessen PhDd

aBarr Plastic Surgery, Consultant Skin MediSpa, Sudbury, Ontario, Canada
bCosmedica Clinic, Pointe-Claire, Québec, Canada
cYouthful Image Clinic, Medical Director, Edmonton, Alberta, Canada
dAndriessen Consultants, Nijmegen, The Netherlands

Abstract

BACKGROUND: Hyaluronic Acid (HA) fillers are widely used for restoring facial volume.
OBJECTIVE: A 24-week study evaluated clinical efficacy with HA.
METHODS AND MATERIALS: Included were 15 healthy subjects recruited from 4 centers, between ages of 35 to 65 years, who had a Wrinkle Severity Rating Scale (WSRS) score ≥ 3, indicating moderate volume loss. Revanesse® Ultra (Prollenium), a HA dermal filler, was used. Primary study outcome was physicians scored facial volume correction, using the Global Aesthetic Improvement Scale (GAIS), comparing baseline (day 0) versus 24 weeks (end) and blindly assessed photographs. Subject satisfaction and comfort was evaluated using self-administered questionnaires at day 0 and at week 24.
RESULTS: N = 15, 13 female and 2 males with a mean age (years) of 48.52 ( SD ± 10.46) received treatment with HA and completed the 24-week study. At screening they had a moderate (mean 2.85, SD ± 0.45) WSRS score. At week 24 a market facial volume restoration was shown and no adverse events were reported. All patients reported to be satisfied with the obtained results.
CONCLUSION: Good – excellent volume enhancement was noted almost immediately after the HA injections, improving patient reported quality of life aspects. HA treatment was shown to be safe.

J Drugs Dermatol. 2015;14(1):19-23.

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INTRODUCTION

Facial aging concerns all facial structures, including skin, soft tissues, muscle, and bone.1-3 In the aging face, redistribution of superficial and deep fat leads to volume loss, contributing to the loss of malar projection and apparent deepening of the nasolabial folds.4 The loss of facial volume results in a loss of support for the skin, which appears to become redundant, such as around the orbicularis oris muscle.1-3

Dermal fillers, such as those containing Hyaluronic Acid (HA), are best used for three-dimensional facial contouring and reflation of the face, correcting volume loss and addressing static rhytides. 3-5 These low viscous HA dermal fillers have been successfully used for facial correction and can be combined with the use of neuromodulators for correcting dynamic rhytides. 3, 6-9

Hyaluronic Acid fillers are the most frequently used class of injectable products for soft tissue augmentation, accounting for 85% of such procedures in 2010.8 In a systematic review on HA injectable fillers used for soft tissue augmentation the authors concluded HA to be safe and well established for correction of nasolabial folds.9 A cross-linked HA dermal filler has been introduced for facial volume correction. Case ascertainment was conducted to evaluate clinical efficacy when using the hyaluronic acid dermal filler for restoring facial volume resulting in correction of nasolabial and mesolabial folds as well as vermillion border lines.

MATERIALS AND METHODS

Revanesse® Ultra (Prollenium) is a HA dermal filler containing 25mg/ml of cross linked HA.

Study Objectives

Primary objective: Physician assessed clinical efficacy
  • Restoring facial volume resulting in a correction of nasolabial folds, mesolabial folds and vermillion border lines, using the GAIS [10,11] comparing baseline (day 0) versus 24 weeks (end).
  • Blindly assessed standardized photographs at baseline and at 24 weeks (end).

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