Efficacy and Tolerability of a New Monophasic, Double-Crosslinked Hyaluronic Acid Filler for Correction of Deep Lines and Wrinkles

February 2011 | Volume 10 | Issue 2 | Original Article | 134 | Copyright © February 2011

Tatjana Pavicic PhD
Clinic and Polyclinic for Dermatology and Allergology, Ludwig-Maximilians-University, Munich, Germany

Abstract
Background: A monophasic, highly crosslinked hyaluronic acid dermal filler offers further treatment options for deep lines.
Objective: To investigate the efficacy and tolerability of Belotero.
Methods and Materials: A total of 149 patients received injections. Efficacy was assessed on the Wrinkle Severity Rating Scale (WSRS) and the Global Aesthetic Improvement Scale (GAIS). Adverse events were recorded at each evaluation session.
Results: Mean WSRS improved significantly (P<0.001) by 1.9 score points without any decline throughout the 12-week period. Improvement was found in 89.9 percent of patients on the (GAIS), 59.7 percent of whom were designated as very much/much improved. Investigator and patient satisfaction was stated in more than 90 percent of cases as excellent/good. Adverse events, exclusively localized to the injection area, occurred in 85.9 percent of patients immediately after injection and declined to 12.8 percent in week 2. None were serious.
Conclusion: The findings indicate the benefit of the highly cross-linked, monophasic hyaluronic acid dermal filler, especially in the treatment of patients with deep and extremely deep folds. Overall, the filler appears to be well tolerated. This evaluation raised no major safety concerns.

J Drugs Dermatol. 2011;10(2):134-139.

Introduction

During the past years, dermal fillers based on hyaluronic acid are increasingly being used in minimal invasive aesthetic dermatology. Hyaluronic acid is an important component of the skin and connective tissues. It consists of an unbranched strongly hydrophilic polysaccharide chain. Thus, in relation to its molecular mass, hyaluronic acid has remarkable water-binding capacity.1 This strong moisturizing property results in a soft, smooth, hydrated and elastic skin.
The injection of dermal fillers based on hyaluronic acid is one of the most relevant methods in the cosmetic treatments of wrinkles, lip augmentation, correction of facial deformities, treatment of HIV-associated lipoatrophy and restoration of facial contour.2
Hyaluronic acid fillers appear to be similar, but their physical characteristics can be quite different. According to these characteristics, they are classified as biphasic or monophasic. Biphasic products are heterogeneous and remain so even after being injected. In contrast to biphasic fillers, which disintegrate to form visible particles, monophasic fillers are purely stabilised, non-particulate gels.
The first monophasic hyaluronic acid filler, which is manufactured using a production process called Cohesive Polydensified Matrix (CPM®) technology, was introduced as Belotero® Basic and Belotero Soft in Germany in 2005. This CPM technology is based on a dynamic double-crosslinking process with BDDE (1,4 Butandiol-Diglycidylether) leading to a cohesive monophasic gel, which has different densities within the gel. This technology adds to its monophasic nature and gives the CPM Gel an unusual elasticity.3 Thus, this CPM Gel is easy to inject through small diameter needles and requires even less injection pressure. The gel diffuses self-acting into the tissue. Those parts with higher density refill and expand the tissue, those with lower density diffuse into the fine pericellular tissue spaces. As a result the injected areas remain smooth.
This monophasic hyaluronic acid filler's range comprises three different concentrations: Belotero Soft (hyaluronic acid concentration 20.0 mg/mL) for the treatment of fine wrinkles and superficial lines, Belotero Basic (hyaluronic acid concentration 22.5 mg/mL) for the correction of medium-to-deep wrinkles and lip augmentation and, recently, Belotero Intense (hyaluronic acid concentration 25.5 mg/mL) for deeper lines and wrinkles, lip augmentation and volume enhancement. For optimum results, the products may be used in combination.
The purpose of this evaluation was to investigate the efficacy and tolerability of the highest hyaluronic acid concentrated gel using the product in mono application as well as in combination with CPM Gel Basic (sandwich procedure).