Open-Label, Post-Marketing Study to Evaluate the Performance and Safety of Calcium Hydroxylapatite With Integral Lidocaine to Correct Facial Volume Loss

January 2019 | Volume 18 | Issue 1 | Original Article | 86 | Copyright © 2019

Gabriele F. Muti MDa

aPlastic Surgery Department, Istituto Dermatologico Europeo, Milan, Italy

Abstract

BACKGROUND: Calcium hydroxylapatite (CaHA, Radiesse®) with integral 0.3% lidocaine (CaHA(+)) has recently been approved for use in aesthetic medicine. This study assessed the performance of CaHA(+) in subjects undergoing treatment for facial volume loss and evaluated subject and physician satisfaction. METHODS: In a prospective, open-label, post-marketing study, 25 women seeking treatment for age-related facial volume loss received CaHA(+) injections in 1–3 facial areas including the cheeks, marionette lines, prejowl sulcus, and jawline. Subjects returned for follow-up at 14 and 120 days, with the option of touch-up injections at day 14 if required to achieve optimal correction. Filler performance was assessed using the Merz Aesthetics Scales (MAS) and subject satisfaction using the Global Impression of Change Scale (GICS). Physician satisfaction was assessed in terms of CaHA(+)-related properties (eg, ease of injection, distribution, positioning) and aesthetic outcomes. Adverse events were recorded. RESULTS: Mean MAS scores at baseline were ~2 corresponding to moderate facial volume loss/sagging in the treated area. At day 14, the mean score had improved to less than equal to 1.4 for all treated areas, indicating mild volume loss. At day 120, mean scores had further improved to less than equal to 1.1. At both follow-up visits, mean GICS scores were less than equal to 2 indicating facial appearance was ‘much improved’ compared with baseline. All subjects reported willingness to repeat treatment and recommend it to family/friends. Physician ratings were high for ease of CaHA(+) injection, distribution, positioning, sculpturing outcome, and effect on skin tension. Compared to CaHA without lidocaine, the physician rated CaHA(+) as better or similar in performance. Adverse events were mostly mild and expected with CaHA and filler injections in general. CONCLUSION: The well-established efficacy and safety profile of CaHA appears unchanged by the addition of integral lidocaine. CaHA(+) was effective for volume enhancement in a number of facial areas and associated with high subject and physician satisfaction. J Drugs Dermatol. 2019;18(1):86-91.

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INTRODUCTION

Research in the past decade has brought significant insight into the mechanisms of facial aging along with the recognition that loss of facial volume plays a major role in an aged facial appearance. This occurs at many levels via a combination of tissue laxity (collagen and elastic tissue breakdown), bone resorption (osteopenia of the facial skeleton), and lipoatrophy.1–4 Dermal fillers have become widely adopted minimally invasive treatment options for a variety of aesthetic indications5 and there is now an array of products that differ significantly in their chemical composition, mechanism and duration of action, safety and interaction with host tissues. Calcium hydroxylapatite (CaHA, Radiesse®, Merz North America, Inc., Raleigh, NC) is a highly effective agent for many areas of facial soft-tissue augmentation that is associated with a long and well-established safety profile.6 In the US, approved aesthetic indications of CaHA are for the correction of moderate-to-severe facial wrinkles and folds, such as nasolabial folds and to correct volume loss in the dorsum of the hands.7–10 CaHA is well suited for facial volume enhancement as a result of its high elasticity and viscosity,11 which provide it with a lifting capacity when molded and contoured into place. Aesthetic benefits from CaHA injection are not just derived from the volume of product injected, but also from the long-term stimulation of the patient's own collagen production12,13 leading to a long duration of effect.14 These physical properties of CaHA provide it with a versatility that makes it suitable for most aspects of facial rejuvenation: line filling, skin tightening, lifting, contouring, and volumizing.

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