Stabilized Hyaluronic Acid-based Gel of Non-animal Origin for Skin Rejuvenation: Face, Hand, and Decolletage

September 2013 | Volume 12 | Issue 9 | Original Article | 990 | Copyright © September 2013


Meike Streker MD, Tilmann Reuther MD, Nils Krueger MD PhD, and Martina Kerscher MD

Division of Cosmetic Sciences, University of Hamburg, Hamburg, Germany

Abstract
BACKGROUND: Mid-dermal injection of stabilized hyaluronic acid (HA) is well established as a treatment to reduce the effects of skin aging.
OBJECTIVE: To assess the efficacy and safety of a stabilized HA-based gel of non-animal origin manufactured using the patented NASHA® technology (Restylane® Vital Light, Q-Med AB, Uppsala, Sweden) administered using a pre-filled micropuncture injector device for rejuvenation of the skin.
METHODS: Three treatment sessions 4 weeks apart were performed on one side of the face, the dorsum of one of the hands and one side of the decolletage, leaving the other side untreated. Skin quality was assessed via blinded live evaluation and subject satisfaction by questionnaire. Aesthetic change was evaluated independently by the subject and a blinded evaluator. Subjects were followed up to week 36.
RESULTS: Thirty subjects aged 40–65 years were enrolled. Overall skin quality across all three treatment areas was judged to be improved on the treated side in over 80% of subjects throughout the study. Significant aesthetic improvements on the treated sides were observed at all visits, with the exception of the decolletage at week 36.
CONCLUSIONS: This was the first study that used a micropuncture injector device for injection of NASHA gel, and reveals that this is a promising treatment option for rejuvenation of the skin.

J Drugs Dermatol. 2013;12(9):990-994.

INTRODUCTION

During skin aging, several complex molecular interactions between skin proteins, lipids, glycosaminoglycans and water occur, leading to the occurrence of wrinkles, reduced elasticity, sagging and skin atrophy.1,2 Although the exact underlying molecular mechanisms involved are not completely understood, the association between aging and changes in skin appearance is well established.1,3 Changes in lifestyle and the desire for a youthful appearance have led to an increased demand for non-surgical and minimally invasive procedures that rejuvenate the skin. Since 1997, there has been a 60% increase in demand for skin rejuvenation procedures (including chemical peels, laser treatment and skin tightening), while in 2011 alone over 1.2 million procedures involving the injection of hyaluronic acid (HA) were undertaken in the US.4
HA makes up approximately two-thirds of the glycosaminoglycans present in the skin.5 It is a naturally occurring component of the dermal extracellular matrix, as such, it is both biocompatible and biodegradable.3 Within the dermal matrix, HA has many roles, though a major function is the binding of water,6 and it is this which is a determinant of skin viscoelasticity, hydration, structure and firmness.7 Skin aging can result from many extrinsic factors such as smoking, excessive alcohol consumption, poor nutrition, and chronic exposure to the sun,8 however, the progressive reduction of HA with age represents the intrinsic aging process common to all and has been proposed as contributing to the most striking alterations over time.9 As such, mid-dermal injection of stabilized HA of non-animal origin manufactured using the patented NASHA® technology (Q-Med AB, Uppsala, Sweden) is well established as a treatment used to reduce the effects of aging on skin.
Injections of NASHA gel products such as Restylane® (Q-Med AB, Uppsala, Sweden) skinboosters have been shown to be efficacious and well tolerated.10-12 They are designed to gradually rejuvenate the skin in areas such as the face, hands, neck and décolletage.13 Previous clinical studies have shown that the use of NASHA gel products can improve the hydration and elasticity of treated skin,11,12 as well as its structure and firmness.10 These treatments can act as a reservoir of long-lasting hydration, thereby leaving the skin smooth and soft, whilst improving skin quality and luster.12
The delivery of NASHA gel using a micropuncture technique has proven effective in skin rejuvenation.11,14 This method involves performing numerous injections of small amounts of gel in a semi-random distribution across the treatment area. In this study, an injector device (Restylane® Injector; Q-Med AB, Uppsala, Sweden) was used. The injector delivers a controlled volume (10 μL per injection), allowing the operator to concentrate solely on the placement of gel into the mid-dermal layers and facilitating an even distribution of gel across the injected area. This ‘split-side’ study was designed to assess the efficacy and safety of a NASHA gel formulation containing 12 mg/mL HA, administered using the injector device for the rejuvenation of the skin. This was the first study to use the injector device for NAHSA gel skin rejuvenation. Investigated areas were the face, the dorsum of the hand and the décolletage.
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