Effect of Midfacial Volume Augmentation With Non Animal Stabilized Hyaluronic Acid on the Nasolabial Fold and Global Aethestic Appearance

September 2015 | Volume 14 | Issue 9 | Original Article | 943 | Copyright © September 2015


Brian S. Biesman MD FACSa and Whitney P. Bowe MDb

aDepartment of Ophthalmology, Dermatology, Otolaryngology, Vanderbilt University Medical Center, Nashville, TN
bDepartment of Dermatology, Icahn School of Medicine at Mount Sinai Medical Center, New York, NY

Abstract
INTRODUCTION: Non animal stabilized hyaluronic acid (Perlane, Galderma, SA) was FDA approved in 2007 for the treatment of facial wrinkles and folds. Off-label use led to the observation that injection of Perlane in the midface improved both global aesthetic appearance and reduced the depth of nasolabial folds. A proof-of-concept trial was undertaken to explore this clinical observation further.
METHODS: Twenty subjects with moderate midfacial volume loss and prominence of nasolabial folds underwent injection of the midface with Perlane between May and July, 2009. The average volume administered was 3.68 +/- 0.55 ml. Assessments were performed by the injecting physician and subject self-assessment for 6 months following treatment.
RESULTS: 17 of 20 subjects completed all study visits. At the 6-month follow up visit 16 of 17 subjects were found to have clinically significant improvement of the midface and 14 of 17 subjects were found to have clinically significant improvement of the nasolabial folds. No serious adverse events occurred.
CONCLUSION: In this early stage, proof-of-concept trial, the majority of patients treated demonstrated clinically significant, aesthetically pleasing improvement 6 months after injection of Perlane in the midface.

J Drugs Dermatol. 2015;14(9):943-947.

INTRODUCTION

Hyaluronic acid (HA) gels are the most commonly utilized injectable fillers throughout the world1, and the demand for this form of nonsurgical rejuvenation continues to grow.2 Initially used for correction of lines and folds, over the past decade enhanced understanding of soft tissue changes that occur with aging have led to the broadened use of HA gels for volume restoration as a foundation upon which to build a rejuvenation platform.3,4 Today practitioners and patients alike have recognized that treating individual lines or folds, without addressing midfacial volume loss, results in less than ideal aesthetic outcomes. Approximately 10 years ago one of the authors (BSB) observed that volume enhancement of the midface with nonanimal stabilized hyaluronic acid (Perlane, Galderma, S.A.) seemed to produce an enhanced global aesthetic appearance as well as reduction in the depth of the nasolabial fold. The need to inject the nasolabial fold, an extremely common practice at the time, was noted to be markedly reduced if the midface were injected first. To explore this observation further, a preliminary, proof of concept study was designed to assess whether midfacial soft tissue augmentation with non animal stabilized hyaluronic acid (Perlane, Galderma S.A.) did in fact reduce the relative severity of nasolabial folds and improve the overall aesthetic outcome.

METHODS

Study Design

The study enrolled subjects 40 to 65 years of age who exhibited moderate mid-facial volume loss and prominence of nasolabial folds as judged by the physician evaluator. Patients with mild or severe midfacial volume loss were excluded. Patients who had undergone any surgical facial procedures in the midface or nasolabial folds (eg, Mohs repair, surgical correction of traumatic injuries) were excluded. Any patients with history of soft tissue augmentation, laser or skin tightening treatment in the 12 months prior to the study onset were excluded.
Patients underwent midfacial injections by one of the authors (BSB), and initial treatment was followed by an optional touch-up 2 weeks later if optimal midfacial augmentation was not achieved based on investigator and patient assessment. Enrollment took place between May 2009 and July 2009. The study was approved by the Western Institutional Review Board. All patients provided written informed consent prior to any study-related procedures.
Subjects: Twenty patients were enrolled. All patients were Caucasian and female with a mean age of 54.65 years (range 46 to 61; SD 4.34 years). Of the 20 patient enrolled, all 20 completed initial follow up visits, but 3 were unable to complete all follow
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